Occlutech P200032C ASD Occluder Every Beat Counts Instruction Manual

Occlutech P200032C ASD Occluder Every Beat Counts

Product Information

Specifications:

• Product: Occlutech ASD Occluder
• Model: P17F02.009
• Version: 06
• Intended Use: Transcatheter closure of ostium secundum-type atrial septal defects (ASD)

Product Usage Instructions

Indication for Use and Area of Application:
The Occlutech ASD Occluder is intended for patients with echocardiographic evidence of ostium secundum-type ASD and clinical evidence of right ventricular (RV) volume overload. These patients typically have a hemodynamically significant left-to-right shunt with 4S4V or RV enlargement.

Contraindications:

• Patient with extensive congenital cardiac anomalies requiring cardiac surgery
• Patient with sepsis or systemic infection within 1 month prior to implantation
• Patient with bleeding disorder, untreated ulcer, or contraindications to aspirin therapy
• Patient with intracardiac thrombi on echocardiography
• Patient unsuitable for cardiac catheterization due to size or condition
• Patient with defect margins less than 5 mm to critical structures

Warnings:

• Device must be implanted by trained physicians experienced in transcatheter ASD closure
• Physicians must be prepared to manage procedure-related emergencies
• Proper device sizing is crucial for optimal results
• Do not use damaged or malfunctioning devices for implantation
• Certain patients may have higher risks and require closer follow-up

Frequently Asked Questions (FAQ)

1. Q: How should I prepare for the implantation procedure?
   A: Prior to the procedure, ensure that the patient meets the indicated criteria and has been properly evaluated for contraindications. Follow all necessary pre-operative protocols as per standard medical practice.

2. Q: What post-implantation care is required for patients?
   A: Patients should undergo regular follow-up visits to monitor the device’s functionality and assess any potential complications.
   Follow the recommended post-procedural care guidelines provided by healthcare professionals.

3. Q: What should I do if I suspect a complication after implantation?
   A: In case of any suspected complications, immediately contact the healthcare provider who performed the implantation for further evaluation and management.

Product Description
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.

Indication for Use and Area of Application
The Occlutech ASD Occluder is a medical device intended for transcatheter closure of ostium secundum-type atrial septal defects (ASD). Patients indicated for ASD closure have:

• echocardiographic evidence of ostium secundum-type ASD,
• clinical evidence of right ventricular (RV) volume overload (hemodynamically significant left-to-right shunt with Qp / Qs ≥ 1.5 or RV enlargement).

Contraindications

The Occlutech ASD Occluder is contraindicated for the following:

• Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
• Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be  administered for 6 months.
• Any patient known to have demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
• Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
• Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

Warnings

• The Occlutech ASD Occluder must be implanted exclusively by physicians trained in its use and are experienced with interventional transcatheter ASD closure techniques.
• Physicians who implant the Occlutech ASD Occluder must be able to recognize, assess and manage procedure-associated emergencies. On-site cardiac surgical support with corresponding personnel must be available.
• The use of improperly size-matched devices could seriously affect hemodynamics and optimal results. Before using this device, physicians shall carefully review the hemodynamic parameters as well as sizing information printed on the labels of the  Occlutech ASD Occluder and its accessories (OPP and Occlutech Delivery Set III (ODS III)). Physicians shall also review the sizing and compatibility chart in section 5.1 (Table 1: Device Sizes and Recommended Occlutech Delivery Sets) before starting a procedure. Careful consideration shall be given to ensure accurate size-matching of its accessories with the corresponding device (i.e., review of device labels and color-coding).
• Before using the Occlutech ASD Occluder, the physician shall carefully review section 9 (Implantation Procedure) including relevant instructions therein on connecting the Occlutech ASD Occluder to the OPP. If a secure connection between the Occlutech ASD Occluder and OPP is not verified as described, disconnection of the device from the pusher may occur and the Occlutech ASD Occluder may embolize causing a life-threatening situation.
• The Occlutech ASD Occluder should not be used with delivery sets other than those recommended in section 5.1 (Table 1: Device Sizes and Recommended Occlutech Delivery Sets).
• After deployment and release of the Occlutech ASD Occluder, complications such as device dislocation or embolization may occur as a result of erroneous positioning or sizing of the device. These complications can present a life-threatening situation to the patient.
• An embolized Occlutech ASD Occluder must be retrieved using a snare and a larger delivery sheath. An emergency kit for the retrieval of the Occlutech ASD Occluder must be available in the catheterization laboratory during the procedure.
• The Occlutech ASD Occluder should only be released from the OPP after the physician has confirmed that the device is positioned correctly. This should be determined by performing fluoroscopy and/or Transesophageal (TEE) or Intracardiac Echocardiography (ICE) to visualize the Occlutech ASD Occluder and to confirm that the device is positioned properly.
• While still connected to the OPP, the Occlutech ASD Occluder can be retrieved or re- positioned using the recommended ODS III.
• The Occlutech ASD Occluder must be used exclusively in accordance with this IFU and its implantation is to be carried out as described in this IFU.
• The physician shall inspect all packaging and labels of all devices before opening and follow the Instructions for Use. If the product box or sterile packaging is damaged in any manner, the Occlutech ASD Occluder shall be considered as unsterile and should not be used.
• The physician shall not use this device or any of its components if a seal appears to be broken (contents may not be sterile); if the label appears marked with text or symbols other than those on the label shown in this IFU or if the label is illegible, inappropriate, or absent.
• The physician shall not use this device or any of its components after the “use by” (expiration) date.
• The Occlutech ASD Occluder and OPP is intended for single use only and is not suitable for re-sterilization. As soon as the Occlutech ASD Occluder and OPP devices are removed from the sterile packaging and used, they are contaminated. Re-use or re-sterilization may compromise the structural integrity of the devices, lead to device failure, and result in patient injury, illness or death.
• If, after inspection by the physician, the Occlutech ASD Occluder appears damaged or does not appear to function properly, the device is not suitable for implantation.
• Patients with a rim < 5 mm from the aortic root may have a higher risk of erosion and if closed using a device, they will require closer follow up. Patients with rim sizes < 5 mm to the coronary sinus, inferior vena cava rim, an atrioventricular valve, or the right upper pulmonary vein may have a higher risk of device embolization and it is best to avoid doing such cases.
• Patients should be advised to avoid strenuous physical activity for a period of at least 2 weeks after device implantation.
• The Occlutech ASD Occluder contains nitinol, an alloy of nickel and titanium. Patients allergic to nickel and/or titanium and/or nickel/titanium-based materials may suffer an allergic reaction to this device. Certain allergic reactions can be serious. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials. Patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty in breathing, or inflammation of the face or throat.

Precautions

• Patients  <8 kg might be at higher risk for complications.
• The use of a single Occlutech ASD Occluder to repair multiple ASDs might bear a risk of inadequate closure or residual shunts.
• Cryptogenic stroke caused by ASD related left circulatory embolism has not been clinically evaluated for the Occlutech ASD Occluder. The use of the Occlutech ASD Occluder has not been studied in patients with patent foramen ovale.
• Use standard interventional cardiac catheterization techniques to place the Occlutech ASD Occluder.
• Placement of the Occlutech ASD Occluder may impact future cardiac interventions, for example transseptal puncture and mitral valve repair.

Device Size

A suitable Occlutech ASD Occluder is determined by the ASD assessment (see section 9.3 Measurement of Defect and Device Sizing) and the device-related sizing information in Table 1 in relation to Figure 1.

Ø LA: Left Atrial Disc Diameter
Ø RA: Right Atrial Disc Diameter
Ø Waist: Maximum Waist Diameter

Figure 1: Schematic picture of the Occlutech ASD Occluder
Table 1: Device Sizes and Recommended Occlutech Delivery Sets

Occlutech ASD Procedure
Pack
Article no.| Occlutech Delivery Set III
Article no.| Occlutech Pistol Pusher Article no.| Ø
Waist [mm]| Ø
LA Disc [mm]| Ø
RA Disc [mm]| Atrial Septal Defect Size (D)
[mm]
---|---|---|---|---|---|---
37ASD06P| 98DS007| 38PP125
(light blue)| 6| 16.5| 12.5| 5 < D :5 6
37ASD07P| 98DS007| 38PP125
(light blue)| 7.5| 18| 14| 6 < D :5 7.5

37ASD09P

| ****

98DS007

| 38PP125
(light blue)| ****

9

| ****

20,5

| ****

16,5

| ****

7.5 < D :5 9

37ASD10P| 98DS007| 38PP125
(light blue)| 10.5| 22| 18| 9 < D :5 10.5
37ASD12P| 98DS009| 38PP165
(yellow)| 12| 27| 23| 10.5 < D :5 12
37ASD13P| 98DS009| 38PP165
(yellow)| 13.5| 28.5| 24.5| 12 < D :5 13.5

37ASD15P

| ****

98DS009

| 38PP165

(yellow)

| ****

15

| ****

30

| ****

26

| ****

12 < D :5 15

37ASD16P| 98DS009| 38PP165
(yellow)| 16.5| 31.5| 27.5| 15 < D :5 16.5
37ASD18P| 98DS009| 38PP165
(yellow)| 18| 33| 29| 15 < D :5 18
37ASD19P| 98DS010| 38PP165
(yellow)| 19.5| 34.5| 30.5| 16.5 < D :5 19.5
37ASD21P| 98DS011| 38PP185
(purple)| 21| 36| 32| 18 < D :5 21
37ASD24P| 98DS011| 38PP185
(purple)| 24| 39| 35| 21 < D :5 24
37ASD27P| 98DS012| 38PP210
(blue)| 27| 42| 38| 24 < D :5 27
37ASD30P| 98DS012| 38PP210
(blue)| 30| 45| 41| 27 < D :5 30
37ASD33P| 98DS012| 38PP210
(blue)| 33| 48| 43| 30 < D :5 33

Pre-Implantation Check
Prior to introducing the Occlutech ASD Occluder in the patient, it is recommended to check whether the device reverts to its original shape after it has been pulled in and pushed out of the loader while immersed in a sterile heparinized saline solution. If the Occlutech ASD Occluder does not revert to its intended shape, it is not suitable for implantation and (see section 9. Implantation Procedure). The physician shall inspect the device prior to its use and check the following:

• OPP size is correct as matched by the label color codes,
• Occlutech ASD Occluder can be properly connected to the OPP,
• Occlutech ASD Occluder can be released from the OPP by operating the release mechanism,
• Occlutech ASD Occluder is firmly attached to the OPP by gently pulling the device a few times and ensuring the Occlutech ASD Occluder can rotate freely.
  In case any of these criteria are not met, the physician should select another device.

Procedural

• This device should only be used by physicians who have been trained in transcatheter techniques and are able to determine suitable patients for procedures using this device.
• Although the device is designed to be used only by experienced users (physicians, professional health care personnel), physicians should participate in the physician training program for new customers to ensure that all implanting physicians are trained on the use of the Occlutech ASD Occluder.
• Standard endocarditis prophylactic therapy should be administered during the procedure.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
• Patient is administered Aspirin 48 hours prior to the procedure, based on patient weight, at a dose of 3 – 5 mg / kg per day.
• Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
• If TEE is used, the patient’s esophageal anatomy must be adequate for placement and manipulation of the TEE probe. 5.4.

Post-Implant

• Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for  6 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6 months is at the discretion of the physician.
• Patients should take appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
• Clinical follow-up with a cardiologist, including visualization of the Occlutech ASD Occluder such as the use of echocardiograms, are recommended at the time of implant, 1-day post-implant, pre-discharge and again at 1 month, 2 months, 6 months, and 12 months post-implant. Immediate follow-up with a cardiologist with the onset of any new symptoms suggestive of erosion or impending erosion, and routine clinical follow-up annually thereafter.

Use in Specific Populations

• Pregnancy – Care should be taken to minimize the radiation exposure to the fetus and the mother.
• Nursing mothers – There has been no quantitative assessment of the presence of leachables from the device/procedure in breast milk, and the risk to nursing mothers is unknown.

Magnetic Resonance Imaging (MRI) Safety Information

Non-clinical testing has demonstrated that the Occlutech ASD Occluder is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

• Static magnetic field of 1.5 T and 3 T only,
• Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m),
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (Normal Operating Mode).
• Under the scan conditions defined above, the Occlutech ASD Occluder is expected to produce a maximum temperature rise of 3ºC after 15 minutes of continuous scanning.

Artifact Information
In non-clinical testing, the image artifact caused by the device extends approximately 5 mm from the Occlutech ASD Occluder when imaged with a gradient echo pulse sequence and a 3 T MRI system.

Potential Adverse Events
Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:

• Air embolism
• Allergic reactions
• Anesthesia reactions
• Apnea
• Arrhythmias
• AV-Fistula
• Bleeding (hemorrhage) requiring treatment
• Cardiac / vascular perforation
• Cardiac tamponade
• Death
• Embolization (peri & post procedural)
• Esophageal injury
• Femoral access complication
• Fever
• Hematoma
• Hypertension or Hypotension
• (Immediate) surgical interventions
• Infections, including endocarditis
• Pericardial effusions
• Pericarditis
• Post-pericardiotomy syndrome
• Pseudo aneurysm
• Pulmonary edema
• Seizure
• Stroke
• Tissue erosion
• Thrombus formation on device
• Thrombosis
• Valvular regurgitation

Tissue Erosion
Tissue erosion refers to the erosion or abrasion of the tissue of the atrium, primarily in the area of the roof of either or both atria, and/or the adjacent aortic root (non-coronary sinus). Tissue erosion, while rare, is a surgical emergency due to the occurrence or impending risk of hemodynamic instability resulting from cardiac tamponade and may lead to severe morbidity or death. Absence of the anterior superior (aortic) rim and device oversizing may be related to the causation of erosion due to the increased likelihood of device- tissue contact in the dynamic anatomic area at highest risk for erosion.

Clinical Summary

The Occlutech ASD Occluder is identical to the Figulla Flex II ASD Occluder and was clinically evaluated as Figulla Flex II ASD Occluder in pre-market clinical trial.

Summary of Premarket Clinical Study
The Figulla Flex II ASD Occluder was assessed in a prospective, international, multicenter randomized controlled trial to investigate the efficacy and safety of the Figulla Flex II ASD Occluder compared to that of the Amplatzer Atrial Septal Occluder (ASO) for transcatheter ASD closure of secundum type. A total of 176 patients were randomized to receive the Figulla Flex II (n=116) or the Amplatzer ASO (n=60) in a 2:1 ratio, respectively. One patient was randomized to the Figulla Flex II ASD Occluder group but was excluded from the analysis because a non-study device was implanted.
The study was performed according to ISO14155 (GCP) and the Declaration of Helsinki in 7 study centers throughout Germany and France. The primary efficacy endpoint was early efficacy success rate, which was defined as the rate of a successful placement of the device, and successful closure of the defects without major complication, surgical reintervention, device embolization or moderate or large residual shunt the day after procedure but no later than 36 hours after the procedure.
An early success rate of 94.8% in the Figulla Flex II ASD Occluder group versus 88.1% in the Amplatzer ASO group (p-value = 0.000066) was achieved. This trial showed statistically significant non-inferior early success for the Figulla Flex II ASD Occluder compared with the Amplatzer ASO. Major complication rates at 36 hours, 6-months, and 12-months are provided below.

Study Design
Occlutech conducted a randomized, controlled, multi-center, open trial to investigate the efficacy and safety of the Figulla Flex II ASD Occluder family compared to that of a control device (the Amplatzer ASO) for transcatheter ASD closure of secundum-type. This study was performed according to ISO14155 (GCP) guidelines and the Declaration of Helsinki in 7 study centers throughout Germany and France from October 2012 to July 2015. Upon reaching the non- inferiority (vs. the Amplatzer ASO) endpoint during a planned interim analysis (75% of patients were enrolled), an independent Data and Safety Monitoring Board (DSMB) recommended the early termination of the study.

The inclusion criteria for patient recruitment into the study included:

• echocardiographic evidence of secundum-type ASD,
• defect diameter of < 38 mm, left-to-right shunt with a Qp / Qs ratio of ≥ 1.5: 1 or the presence of right ventricular volume overload as assessed by TTE or clinical symptoms due to the ASD,

• 5 mm distance from the ASD margins to the coronary sinus, arterio-ventricular valves, and right upper pulmonary vein as measured by echocardiography.

The key exclusion criteria were:

• multiple ASDs which could not adequately be covered by the devices,
• associated congenital cardiac anomalies that required cardiac surgery,
• other ASD types, like ostium primum or sinus venous ASDs, or
• partial anomalous pulmonary venous drainage,
• pulmonary vascular resistance above 7 wood units,
• right and/or left ventricular decompensation with ejection fraction of <30%,
• body weight < 8 kg.

Study Population Demographics and Baseline Parameters

Major demographic data and medical history of the patient cohort are shown below in Table 2 and Table 3.

Table 2: Demographic Summary by Treatment Group

Parameter| Figulla Flex II ASD Occluder
(N=115)| Amplatzer ASO (N=60)
---|---|---
Mean Age (years) (SD)

Min, Max

| 20.4 (18.89)
3, 79| 21.1 (20.77)
3, 77
Gender n (%)
Male Female| 39 (33.9%)
76 (66.1%)| 21 (35.0%)
39 (65.0%)
Mean Weight (kg) (SD)
Min, Max| 45.8 (27.16)
13, 104| 47.0 (29.48)
13, 125
Ages 2-17 years Mean Weight (kg)
Min, Max| N = 70
27.6
13, 70| N = 38
28.7
13, 73
Ages ≥18 years
Mean Weight (kg) Min, Max| N = 45
74.1
45, 104| N = 22
78.6
54, 125
Mean Height (cm) (SD)| 143.0 (27.77)| 143.3 (26.87)

Table 3: Patient Medical History by Treatment Group

Most Common Medical History –Body System| Figulla Flex II ASD Occluder (N=115)| Amplatzer ASO (N=60) n (%)
---|---|---
| n (%)|
---|---|---
Congenital/Chromosomal Abnormality1| 115 (100.0)| 60 (100.0)
Any Past and/or Concomitant Diseases or Past Surgeries/Interventions| 115 (100.0)| 60 (100.0)
Circulatory System| 69 ( 60.0)| 33 ( 55.0)
Head, Eyes, Ears, Nose, Throat| 25 ( 21.7)| 12 ( 20.0)
Respiratory System| 21 ( 18.3)| 13 ( 21.7)

1. ASD was considered a congenital abnormality, so all patients have this condition.

ASD Sizing and Device Selection

Device size was selected based predominantly on the stretched ASD diameter using a sizing balloon, “Stop-Flow Technique” and standard imaging methods. Mean ASD size in both groups is reported in Table 4 below.

Table 4: ASD Size

ASD Size

| Figulla Flex II ASD Occluder (N=115)| Amplatzer ASO (N=60)
---|---|---
Mean MM (SD) [range]| 16.02 +/- 4.878
[4.0, 31.0]| 15.07 +/- 5.550
[5.3, 29.0]

Performance
Procedural and fluoroscopy exposure time (Table 5), successful acute device placement (Table 6), successful defect closure and level of residual shunt (Table 7), and were assessed as device performance evaluations.

Table 5: Evaluation of Device Performance

**Parameter| ****Figulla Flex II ASD Occluder (N=115)| ****Amplatzer ASO (N=59)**
---|---|---
Mean Duration of Procedure (min)| 47.8 (35.22)| 53.8 (41.16)
Mean Fluoroscopy Time (min) (SD)| 2.4 (4.40)| 3.7 (5.99)

Table 6: Acute Device Placement Success

**Parameter| ****Figulla Flex II ASD Occluder (N=115)| ****Amplatzer ASO (N=59)**
---|---|---
Successful Device Placement| 115/115 (100%)| 57/59 (96.7%)

After device placement, an echo evaluation was performed to determine closure status. Results below are from the Central Lab read. Six patients did not have Central Lab reads completed and therefore were not evaluable.

Table 7: Residual Shunt Post Implant

**Residual shunt| Figulla Flex II ASD Occluder (N=115)| Amplatzer ASO (N=59)**
---|---|---
n| 110 (100.0)| 58 (100.0)
No Shunt| 99 (90.0)| 48 (82.8)
Trivial| 4 (3.6)| 2 (3.4)
Small| 4 (3.6)| 4 (6.9)
Moderate| 3 (2.7)| 3 (5.2)
Large| 0| 1 (1.7)

Effectiveness and Safety Results
Device Efficacy
Primary Efficacy Results
The primary efficacy endpoint was early efficacy success rate, which was defined as the rate of a successful placement of the device, and successful closure of the defects without major complication, surgical re-intervention, device embolization or moderate or large residual shunt the day after procedure but no later than 36 hours after the procedure. The assessments showed statistically non-inferior early success for the Figulla Flex II ASD Occluder compared with the Amplatzer ASO.
The early success rates are presented in Table 8.

Secondary Efficacy Results
Secondary efficacy endpoints were:

• the rate of closure success (residual shunt ≤2 mm, assessed by an echocardiography core laboratory) within 6 months after the procedure, without the need for surgical repair.

The secondary efficacy endpoint results are presented in Table 8.

Table 8: Primary and Secondary Endpoints- Closure Success Rate

Assessment| Occlutech ASD
Occluder (N=115)| Amplatzer
ASO (N=59)|
---|---|---|---
Primary Efficacy Results| 109/115 (94.8%)| **** 52/59 (88.1%)| p-value
0.000066
Secondary Efficacy Results| 94/115 (81.7%)| 42/59 (71.2%)| 95% CI
-2.99, 24.10

Safety
The safety assessment was performed with data at 36 hours, 6- and 12-months post implantation (Table 9).

Safety events of interest included the following:

• Major complications rate at 6- and 12-months post procedure
• Minor complications rate at 6-months and 12-months post procedure
• All other device or procedure related adverse events at 6- and 12-months post procedure

Major complications were defined as stroke, cardiac perforation with tamponade, endocarditis, repeat surgery, death, pericardial effusion with tamponade, arrhythmia requiring major treatment, and device embolization requiring surgery. Minor complications were defined as device embolization requiring percutaneous treatment, arrhythmia requiring medical therapy, vascular access site complications.

Table 9: Major Complication Rates

| Figulla Flex II ASD Occluder| Amplatzer ASO
---|---|---
Major complication rate 36 hours Patients (%)| 3/115 (2.61 %)| 4/60 (6.67 %)
Major complication rate 6 months Patients (%)| 5/99 (5.05 %)| 6/49 (12.25 %)
Major complication rate 12 months Patients (%)| 6/76 (7.90 %)| 6/39 (15.39 %)

Table 10: Number (%) of Patients with Most Frequent Treatment-emergent Adverse Events (≥ 5 % for any group)

| Figulla Flex II ASD Occluder (N= 115)| Amplatzer ASO (N= 60)
---|---|---
| n (%)| n (%)
Total Patients with Any TEAE| 82 (71.3)| 43 (71.7)
Adverse Event| |
Headache| 13 (11.3)| 8 (13.3)
Related study devicea| 0 (0.0)| 0 (0.0)
Related study procedureb| 1 (0.9)| 1 (1.7)
Hematoma| 13 (11.3)| 3 (5.0)
Related study devicea| 1 (0.9)| 0 (0.0)
Related study procedureb| 12 (10.4)| 2 (3.3)
Chest pain| 9 (7.8)| 2 (3.3)
Related study devicea| 2 (1.7)| 2 (3.3)
Related study procedureb| 2 (1.7)| 0 (0.0)
Vomiting| 6 (5.2)| 5 (8.3)
Related study devicea| 0 (0.0)| 0 (0.0)
Related study procedureb| 0 (0.0)| 2 (3.3)
Palpitations| 7 (6.1)| 2 (3.3)
Related study devicea| 0 (0.0)| 0 (0.0)
---|---|---
Related study procedureb| 0 (0.0)| 0 (0.0)
Epistaxis| 7 (6.1)| 1 (1.7)
Related study devicea| 1 (0.9)| 1 (1.7)
Related study procedureb| 0 (0.0)| 0 (0.0)
Infection| 3 (2.6)| 4 (6.7)
Related study devicea| 0 (0.0)| 0 (0.0)
Related study procedureb| 0 (0.0)| 0 (0.0)
Groin pain| 3 (2.6)| 3 (5.0)
Related study devicea| 0 (0.0)| 0 (0.0)
Related study procedureb| 3 (2.6)| 3 (5.0)
Respiratory tract infection| 2 (1.7)| 3 (5.0)
Related study devicea| 0 (0.0)| 0 (0.0)
Related study procedureb| 0 (0.0)| 0 (0.0)
Device dislocation| 1 (0.9)| 3 (5.0)
Related study devicea| 0 (0.0)| 3 (5.0)
Related study procedureb| 1 (0.9)| 3 (5.0)
Bronchitis| 1 (0.9)| 3 (5.0)
Related study devicea| 0 (0.0)| 0 (0.0)
Related study procedureb| 0 (0.0)| 0 (0.0)

Implantation Procedure: Directions for Use

The Occlutech ASD Occluder is intended for transcatheter delivery. To minimize the risk of adverse events occurring, the following manufacturer’s recommendations must be reviewed before implantation of the device.
The Occlutech ASD Occluder shall only be implanted by an experienced and trained physician, and in a specialized catheterization laboratory.

Required Accessories (not included in the Occlutech ASD Occluder Procedure Pack)

• Occlutech Delivery Set III (ODS III)
• Guide wire
• Appropriate accessories to manage potential adverse events.

Recommended Imaging Tools

• X-ray, fluoroscopy
• TEE or ICE (recommended before, during and after implantation. If TEE is used, the patient’s esophageal anatomy must be adequate for the placement and manipulation of the TEE probe).

Recommended Measurement of Defect and Device Sizing
Warning: The use of improperly size-matched devices could seriously affect hemodynamics and optimal results. Before using this device, physicians shall carefully review the hemodynamic parameters. Sizing shall be based on echocardiographic assessment of type, size and number of atrial septal defects and matched with the sizing information printed on the labels of the Occlutech ASD Occluder and its accessories (OPP and ODS III).
Physicians shall review the sizing and compatibility chart (see section 5.1 Table 1: Device Sizes and Recommended Occlutech Delivery Sets) before starting a procedure. Careful consideration shall be given to ensure accurate size- matching of its accessories with the corresponding Occlutech ASD Occluder (i.e., review of device labels and color-coding).

1. Access the right femoral vein and perform a routine right heart catheterization.
2. Assess the secundum ASD simultaneously either by TEE or ICE resulting in a comprehensive echocardiographic study of all aspects of the ASD anatomy, including location, size, presence of additional defects and adequacy of the Superior/Superior Vena Cava rim; Anterior-Superior/Aortic rim; Inferior/Inferior Vena Cava and Coronary Sinus rim; and Posterior rim.
3. Select a guide wire (0.035”-0.038”), and with the use of a multipurpose catheter (e.g., 5- French) cross the atrial septal defect and place the guide wire in the upper pulmonary vein.
4. Prepare an appropriate sizing balloon according to the manufacturer`s guideline.
5. Remove the multipurpose catheter.
6. Advance the sizing balloon using the over-the-wire technique into the heart and place it across the ASD under fluoroscopic and echocardiographic guidance.
7. Defect sizing should be performed using the “stop-flow-technique”: The TEE/ICE ultrasound probe shall be in place and color doppler mode activated to visualize the ASD shunt flow. Inflate the balloon by inserting diluted X-ray contrast medium (typically 1:2 concentration) over the side port of the balloon. The left-to-right shunt ceases and a clearly defined waist becomes visible as observed by color-Doppler TEE/ICE.
8. Perform precise ASD measurement by echocardiographic and/or fluoroscopic visualization of indentation made by the ASD margins (ASD margins can be measured if the balloon is displayed in the long axis during imaging). Ideally, two orthogonal measurements are taken to evaluate the potentially ellipsoidal shape of the ASD. If reference measurements are required to calibrate the x-ray quantification, markers are visible on the balloon catheter. Please refer to the manufacturer`s guidelines for further details on additional imaging techniques.
9. All borders, so called “rims” and distances to surrounding structures shall be measured. Warning: Improper evaluation of the ASD bears the risk of erosion. Deficient retro-aortic rim <5 mm (“naked aorta”), or a deficient superior rim significantly increases the risk of erosion.

Implantation

1. Based on precise ASD measurement and device-related sizing information (see section 5.1. Table 1: Device Sizes and Recommended Occlutech Delivery Sets), select an appropriate Occlutech ASD Occluder and the size-matched recommended ODS III.

2. Unpack and prepare the ODS III as described in its IFU.
   Flush the loader assembly via the side port with three-way stopcock ensuring it is free of air prior to use.
   Percutaneous delivery shall be performed using the over-the-wire method, with the use of the dilator. Delivery sheath placement shall be performed under the guidance of imaging methods, like TEE, fluoroscopy or ICE.

3. After positioning of the delivery sheath in the left atrium, the guide wire and dilator can be entirely removed.
   Warning: Do not abruptly remove the dilator from the left atrium as the risk for causing an air embolism can occur.

4. Remove the OPP and the Occlutech ASD Occluder from its sterile packaging and check for device integrity and pusher functionality.

5. Place the Occlutech ASD Occluder in a bowl filled with a sterile heparinized saline solution. Follow the instructions in Table 11, to connect the Occlutech ASD Occluder to the OPP.

6. Insert the distal end (jaw-container) of the OPP through the hemostasis valve of the loader.
   Table 11: Occlutech ASD Occluder-OPP Connection Instructions 6a. Open the jaws of the OPP (see pusher IFU for detailed device components and descriptions).
   The OPP is provided in the “Un-lock” position.
   Be sure that the ‘Unlock button’ is in the correct ‘Unlock’ position.| Pull the trigger of the OPP while the pusher cable is in a straight position.

---|---
6b. Connect the open jaws o the OPP to the Occlutech ASD Occluder’s ball connector.
Note: After connecting the OPP to the Occlutech ASD Occluder, make sure that the occluder can rotate freely. If not, disconnect and re- connect the Occlutech ASD Occluder to the OPP.| ****

7. The Occlutech ASD Occluder is now attached to the OPP and shall be pulled into the loader while both the occluder and loader (distal end) are immersed in a sterile heparinized saline solution.

8. The following steps constitute a potential risk of introducing air into the ODS III, which may lead to an air embolism. It is important to ensure that all air-bubbles are removed from the loader and the delivery sheath as described:

   • After the Occlutech ASD Occluder has been completely retracted into the loader, the loader-occluder assembly must be thoroughly flushed using the sterile heparinized saline solution to remove any air-bubbles by using a full 20 mL syringe connected to the side-port of the loader.

9.  Introducing the catheter: Make sure that there is no air in the delivery sheath and the loader, as there is a risk of air embolism.

10. Once the loader-occluder assembly is connected to the delivery sheath, the Occlutech ASD Occluder can be pushed from the loader into the delivery sheath by advancing the OPP. Use x-ray guidance to visualize the Occlutech ASD Occluder advancement up to the distal end of the delivery sheath which should be positioned in the left atrium.

11. Once in place, the left atrial disc of the Occlutech ASD Occluder is opened by carefully advancing the OPP towards the distal end of the delivery sheath. After the left atrial disc has been successfully deployed in the left atrium, it is pulled carefully together with the sheath towards the atrial septum until resistance is felt. TEE, TTE or ICE imaging should be used to confirm proper positioning of the left atrial disc at this time.

12. Upon confirmation that the left atrial disc is engaged with the septum and the delivery sheath is in the left atrium, the right atrial disc of the Occlutech ASD Occluder is opened in the right atrium. Gently retract the delivery sheath over the OPP cable, while keeping the OPP cable in a stable position until the device has been completely deployed. Do not disconnect the Occlutech ASD Occluder from the OPP.

13. Correct positioning of the Occlutech ASD Occluder must be confirmed through a combination of fluoroscopic analysis and/or echocardiography.

14. If the Occlutech ASD Occluder does not adequately fit upon deployment, a correction of its position must be considered (see section 9.5. Notes for Troubleshooting). If repositioning of the device cannot be achieved, or a significant shunt remains, the Occlutech ASD Occluder should be withdrawn back into the delivery sheath and removed.

15. If the optimal fit and positioning of the Occlutech ASD Occluder has been established and confirmed by use of TEE, TTE, fluoroscopy or ICE, then the OPP can be safely disconnected from the Occlutech ASD Occluder (see Table 12).
    Note: Do not disconnect the Occlutech ASD Occluder from the OPP if the occluder does not conform to its original configuration, if the device position appears unstable, or if the device interferes with any adjacent cardiac structures such as:

    • the superior vena cava (SVC),
    • pulmonary vein (PV),
    • mitral valve (MV),
    • coronary sinus (CS)
    • aorta (AO).
      In this case, the device position must be corrected. see section 9.5. Notes for Troubleshooting. If it is not possible to improve the position of the Occlutech ASD Occluder, the device must be removed and discarded.
      Note: The physician should only disconnect the Occlutech ASD Occluder from the OPP once proper positioning of the device has been confirmed using echocardiographic imaging.
      Table 12: Releasing the Occlutech ASD Occluder from the OPP. 15a. Unlocking the Occlutech ASD Occluder-OPP-connection.| Move the ‘Unlock’ button to the handle of the OPP to its ‘Unlocked’ position.
      ---|---
      15b. Open the jaws and disconnect / release the Occlutech ASD Occluder.| Slowly pull the trigger mechanism located on the handle at the proximal OPP end.

16. After the Occlutech ASD Occluder has been disconnected, the delivery sheath together with the OPP and the loader can be entirely retracted and discarded (see section 12. Disposal).

Notes for Troubleshooting
Incorrectly Positioned Device
If the Occlutech ASD Occluder is not properly positioned after opening both discs, a correction of the position is required. To do so, the device must be completely withdrawn into the delivery sheath. Thereafter, another attempt to place and position the Occlutech ASD Occluder can be made. If positioning of the device cannot be improved, the Occlutech ASD Occluder should be withdrawn into the delivery sheath and removed and, and distributor should be contacted.

Misconfigured Device
If the Occlutech ASD Occluder does not conform to its intended shape during positioning, the device must be withdrawn completely into the delivery sheath by retracting the pusher. The Occlutech ASD Occluder should be removed and distributor should be contacted.

Storage Conditions

• Temperature: 5 to 30 °C (41 to 86 °F).
• Store in a dry place.

Disposal
All Occlutech devices should be disposed of properly according to the applicable regulations, guidelines or instructions on waste disposal given by the individual clinic.
Note: The empty outer and sterile packaging and IFU can be disposed separately. Put in the corresponding collection containers for recycling purposes.

Warranty
Occlutech Holding, Switzerland warrants to buyer that, for a period equal to the validated shelf life of the product, this product shall meet the product specifications established by the manufacturer when used in accordance with the manufacturer`s instructions for use and shall be free from defects in materials and workmanship.
Occlutech Holding, Switzerland disclaims all warranties, both express and implied, including, but not limited to, any implied warranty of merchantability, fitness for a particular purpose, or non-infringement.

Glossary of Symbols

Appendix: Information that appears on the IFU cover only

Occlutech GmbH
Winzerlaer Straße 2
07745 Jena, Germany

Distributed by:
B. Braun Interventional Systems Inc. Bethlehem, PA 18018-3524 Customer Service:
TEL: 877-836-2228
FAX: 610-849-1334
for Occlutech Holding AG
Feldstrasse 22
8200 Schaffhausen, Switzerland
For contact and additional product information, please visit www.bisusa.com
Issue date: Rev. 0X, YYYY-MM-DD

Product Description

The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.

Figure 1: Representative image of Occlutech Pistol Pusher and its proximal, body and distal parts.
The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism – grab and secure the ball connector of the compatible Occlutech ASD Occluder, allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release.
The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.
For compatibility between the Occlutech Pistol Pusher, Occlutech Delivery Set III (ODS III) and Occlutech ASD Occluder, see the Occlutech ASD Occluder Instructions for Use (IFU), (Table 1. Device Sizes and Recommended Occlutech Delivery Sets).
Physicians must also carefully read the IFU of the Occlutech ASD Occluder provided within the same product box.

Table 1: Recommended Occlutech Pistol Pusher with compatible ODS III and internal diameters.

Occlutech Pistol Pusher article number
(with color codes)| Length [cm]| Jaw container outer diameter
ØD max [mm]| **Minimum internal diameters of compatible delivery systems*
---|---|---|---
38PP125
Light blue| 120| 2.13| 7F

(≥ 2.23 mm)

38PP165
Yellow| 120| 2.73| 8F (2.83 mm)
38PP185
Purple| 120| 2.93| 9F (3.03 mm)
38PP210
Blue| 120|

3.23

| 10F (3.33 mm)

*Based on compatibility testing performed with ODS III (Article no. 98DSXXX)
** Delivery sheath diameter labeled as 7F, since tolerances of internal delivery sheath diameter may be insufficient to ensure compatibility of smaller delivery sheath at the lower limit of the internal diameter (6F).

Indication for Use
The Occlutech Pistol Pusher is a percutaneous, transcatheter pusher system designed for the delivery of the Occlutech ASD Occluder to the implantation area. It is used via a minimally invasive catheter delivery system technique.

Contraindications
For contraindications, please see the IFU of the Occlutech ASD Occluder.

Warnings
For Procedure

• The Occlutech Pistol Pusher shall not be used with ODS III other than those listed in Table 1. Furthermore, the correct size of the Occlutech Pistol Pusher and compatible ODS III must be followed. Should the recommended size-matched systems not be followed, the device may be damaged and/or serious adverse events can occur.

• The Occlutech Pistol Pushers shall only be used in connection with the Occlutech ASD Occluder!

• The Occlutech Pistol Pushers are supplied sterile for single use!

• Prior to the application the Occlutech Pistol Pusher must be checked for functionality, distal tip surface properties and damage!

• Only intact and sterile Occlutech Pistol Pushers should be used!

• The Occlutech Pistol Pusher should only be used once!

• Compare the size of the Occlutech Pistol Pusher with the size of the ODS III!

• Before use ensure that the sticker color on the procedure pack as well as the occluder pouch matches with the color of the Occlutech Pistol
  Pusher proximal part!

• The Occlutech Pistol Pusher shall be used exclusively by physicians, who are trained in this type of cardiac treatment and experienced in the process of interventional transcatheter ASD closure techniques.

• Physicians who implant the Occlutech ASD Occluder must be able to recognize, assess and manage procedure associated emergencies. On-site cardiac surgical support with corresponding personnel must be available.

• In cases where the “Handling” (section 6) is not followed and the “Warnings” (section 4)are overlooked, severe complications can occur.

• Disconnection of the Occlutech Pistol Pusher from the Occlutech ASD Occluder can occur undetected, resulting in Occlutech ASD Occluder embolization during
  implantation. This presents a life-threatening situation for the patients.

• The Occlutech Pistol Pusher is only recommended for the Occlutech ASD Occluder.

Labeling and Packaging
Identifications for the Occlutech Pistol Pusher including correct labeling should be verified before proceeding. The following are considerations:

• Occlutech Pistol Pusher packaging damaged. This can impair sterility. ? Occlutech Pistol Pusher marked by an illegible or inappropriate label.
• Occlutech Pistol Pusher for which the labeling is missing.

If the packaging box or double plastic pouches are damaged in any way, the Occlutech Pistol Pusher shall be considered unsterile and should not be used.
If, after inspection by the physician, the Occlutech Pistol Pusher appears damaged or does not appear to function properly, it is not suitable for use and the distributor should be contacted.

Re-use

• The Occlutech Pistol Pusher is intended for single use only. The Occlutech Pistol Pusher and the Occlutech ASD Occluders are not suitable for re-sterilization. As soon as the Occlutech Pistol Pusher is used, it is contaminated. Re-use of a contaminated Occlutech Pistol Pusher, may cause a high risk of injury to the patient, including sepsis.

Adverse Events

The adverse events that may occur during or after a procedure include but are not limited to:

• Cardiac arrhythmia
• Formation of blood clots, vascular injury and occlusion due to existing vascular calcification and heart disease
• Unintentional injuries to the heart
• Injuries to the blood vessels
• Bleeding or secondary bleeding in the heart or pericardium due to injury of the heart
• Infection via the point of introduction
• Pulmonary embolism
• Arterial embolism
• Cardiac tamponade
• Perforation
• Cardiac arrest
• Damage of heart valves and other structures
• Death

For compatible Occluder-related adverse events, please see the Occlutech ASD Occluder IFU.

Handling

Preparation
Note: Prior to the application, the Occlutech Pistol Pusher shall be checked for functionality (opening and closing of the jaws), the parts shall not contain any burr marks or sharp edges nor be curved or oppressed. The surface of the distal tip should be smooth and not roughened or damaged. All delivery sheaths and related equipment should be flushed and deaired according to local practice before insertion into the patient.

1. Remove the Occlutech Pistol Pusher and compatible ODS III (delivery sheath and loader) from its sterile packaging and check for device functionality. Flush the loader assembly via the side port with three-way stopcock ensuring it is free of air prior to use.
2. Insert the distal end (jaw-container) of the Occlutech Pistol Pusher through the hemostasis valve of the loader.
3. Remove the compatible Occlutech ASD Occluder from its sterile packaging and check for occluder integrity. Follow the instructions in Table 2, on how to connect the Occlutech ASD Occluder to the Occlutech Pistol Pusher.
   Table 2. Occlutech ASD Occluder-Occlutech Pistol Pusher Connection Instructions 3b. Connect the open jaws of the Occlutech Pistol Pusher to the Occlutech ASD Occluder’s ball connector.
   Note: After connecting the Occlutech Pistol Pusher to the Occlutech ASD Occluder, ensure that the occluder can rotate freely. If not, disconnect and re-connect the Occlutech ASD Occluder to the Occlutech Pistol Pusher.|
   ---|---
   3c. Secure the Occlutech ASD Occluder – Occlutech Pistol Pusher connection.
   Note : A secure occluder – Occlutech Pistol Pusher connection is required to prevent any unintentional release of the occluder from the Occlutech Pistol Pusher.| Push the ‘Lock’ button of the Occlutech Pistol Pusher to its ‘Locked’ position while the pusher cable is in a straight position.

Note: Be sure that the Occlutech Pistol Pusher is in ‘Locked’ position before pulling the Occlutech ASD Occluder into the loader.

4. The Occlutech ASD Occluder is now attached to the Occlutech Pistol Pusher and shall be pulled into the loader while both the occluder and loader (distal end) are immersed in a sterile heparinized saline solution.
5. The following steps constitute a potential risk of introducing air into the ODS III, which may lead to an air embolism. It is important to ensure that all air-bubbles are removed from the loader and the delivery sheath as described:
   • After the Occlutech ASD Occluder has been completely retracted into the loader, the loader-occluder assembly must be thoroughly flushed using the sterile heparinized saline solution to remove any air-bubbles by using a full 20 mL syringe connected to the side-port of the loader.

Introducing the Delivery Sheath
Note. See the Occlutech ASD Occluder IFU for detailed information on the Occlutech ASD Occluder implantation procedure.

1. Ensure that there is no air in the delivery sheath and the loader, as there is a risk of air embolism. Secure the loader by screwing the swivel ring tightly on the delivery sheath.
2. Once the loader-occluder assembly is connected to the delivery sheath, the Occlutech ASD Occluder can be pushed from the loader into the delivery sheath by advancing the Occlutech Pistol Pusher. Use x-ray guidance to visualize the occluder advancement up to the distal end of the delivery sheath which should be positioned in the left atrium.
3. Once in place, the left atrial disc of the Occlutech ASD Occluder is opened by carefully advancing the Occlutech Pistol Pusher towards the distal end of the delivery sheath. After the left atrial disc has been successfully deployed in the left atrium, it is pulled carefully together with the delivery sheath towards the atrial septum until resistance is felt. Maintain the relationship between the OPP and the delivery sheath while withdrawing the system, until the left atrial disc is engaged with the septum. TEE, TTE or ICE imaging should be used to confirm proper positioning of the left atrial disc at this time.
4. Upon confirmation that the left atrial disc is engaged with the septum and the delivery sheath is in the left atrium, the right atrial disc of the Occlutech ASD Occluder is opened in the right atrium. Gently retract the delivery sheath over the Occlutech Pistol Pusher cable, while keeping the Occlutech Pistol Pusher cable in a stable position until the occluder has been completely deployed. Do not disconnect the Occlutech ASD Occluder from the Occlutech Pistol Pusher.
5. If the optimal fit and positioning of the occluder has been established and confirmed by use of TEE, TTE, fluoroscopy or ICE, then the Occlutech Pistol Pusher can be safely disconnected (see the Occlutech ASD Occluder IFU for detailed occluder implantation).
6. Follow the instructions in Table 3, to release the occluder from the Occlutech Pistol Pusher.
   Table 3: Releasing the Occlutech ASD Occluder from the Occlutech Pistol Pusher. 6a. Unlocking the Occlutech ASD Occluder-Occlutech Pistol Pusher connection.| Move the ‘Unlock’ button on the handle of the Occlutech Pistol Pusher to its ‘Unlocked’ position.

---|---
6b. Open the jaws and disconnect / release the Occlutech ASD Occluder.| Slowly pull the trigger mechanism located on the handle at the proximal Occlutech Pistol Pusher end.

7.  After the Occlutech ASD Occluder has been disconnected, the delivery sheath together with the Occlutech Pistol Pusher and the loader can be entirely retracted and discarded (see section 8. Disposal).

Due to the anatomy of the heart, circumstances may arise where the geometric arrangement of the Occlutech ASD Occluder and the Occlutech Pistol Pusher is unfavorable and as such, the release is made more difficult. To solve the problem, slide the Occlutech Pistol Pusher forward slightly and attempt to release by turning the fixture between the Occlutech Pistol Pusher and the Occlutech ASD Occluder. Ensure that the jaws of the Occlutech Pistol Pusher do not penetrate into the cardiac tissue/occluder tissue and only carry out this procedure under X-ray screening.

Storage Conditions
Temperature: 5°C – +30°C (41 to 86 °F).
Do not place objects on the instruments and/or their packaging!
Do not store in the vicinity of a chemicals, disinfectants or radiation!
Do not expose the instrument to direct or indirect sunlight or other ultraviolet radiation!
No complaints can be made with respect to improperly stored instruments.

Disposal
All Occlutech devices should be disposed of properly according to the applicable regulations, guidelines or instructions on waste disposal given by the individual clinic.
Note: The empty outer and sterile packaging and IFU can be disposed separately in the corresponding collection containers for recycling purposes.

Warranty
Occlutech Holding, Switzerland warrants to buyer that, for a period equal to the validated shelf life of the product, this product shall meet the product specifications established by the manufacturer when used in accordance with the manufacturer`s instructions for use and shall be free from defects in materials and workmanship.
Occlutech Holding, Switzerland disclaims all warranties, both express and implied, including, but not limited to, any implied warranty of merchantability, fitness for a particular purpose, or non-infringement.

Glossary of Symbols

Issue Date: Rev. 0X, YYYY-MM-DD

Appendix: Information that appears on the IFU cover only
Occlutech Tibbi Ürünler San. Ve Tic. Ltd. Sti
Yesilköy SB Mah., E Blok Sok.
Occlutech Apt. No: 6
34149 Bakirköy / Istanbul, Türkiye
for Occlutech Holding AG Feldstrasse 22 8200 Schaffhausen, Switzerland

Distributed by:
B. Braun Interventional Systems Inc.
Bethlehem, PA 18018-3524

Customer Service:
TEL: 877-836-2228
FAX: 610-849-1334
For contact and additional product information, please visit www.bisusa.com

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