ZOLL SSO2 TherOx Therapy Patient User Guide

ZOLL SSO2 TherOx Therapy Patient

Indications for Use

The TherOx® System is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.

Patient Selection Criteria

• Patient must be ≥ 18 years and < 80 years of age.
• Less than 6 hours from symptom onset to successful reperfusion by means of PCI with stenting of left anterior descending coronary artery ST-elevation AMI.
• Successful revascularization by means of PCI with stenting as documented by < 50% diameter residual stenosis and TIMI flow grade II or III in the target vessel.
• Systemic arterial pO2 greater than or equal to 10.7 kPa or 80 mmHg with supplemental oxygen.

Contraindications

• Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated.
• Presence of an intra-aortic balloon pump.
• Proximal coronary stenosis that restricts flow with the SSO2 Catheter in place.
• Presence of a post-intervention non-stented coronary dissection or perforation.
• Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy.
• Pregnant or nursing women.
• Cardiogenic shock.
• Patients contraindicated for anticoagulation therapy.
• Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
• Hemoglobin < 10 g/dL.
• Gastrointestinal or genitourinary bleeding within the last two months, or any major surgery (including CABG) within the previous six weeks.

Patient-Related Warnings

• SuperSaturated Oxygen Therapy must be performed in the cardiac catheterization laboratory (cath lab). The patient must not be moved while the catheter is in place.
• Under no circumstances should the extracorporeal circuit be disconnected and restarted outside the cath lab.
• Do not use any type of catheter for SSO2 Therapy other than the SSO2 Catheter.
• The DownStream System may not be operated concomitantly with magnetic resonance imaging.
• Use aseptic technique throughout procedure.
• Use only 0.9% Normal saline (Isotonic solution).
• Do not exceed the SSO2 Therapy duration of 60 minutes.
• Provide adequate anticoagulation prior to and during therapy per clinical practice standards. (Refer to anticoagulation section for details).

Anticoagulation Protocol

Bivalirudin is recommended for SSO2 Therapy, but patient anticoagulation must consist of one of the following regimens:

• Bivalirudin and cangrelor, with provisional (bail-out) use of GP IIb/IIIa inhibitors allowed
• Bivalirudin, with provisional (bail-out) use of GP IIb/IIIa inhibitors allowed
• Heparin and cangrelor, with provisional (bail-out) use of GP IIb/IIIa inhibitors allowed
• Heparin and routine use of GP IIb/IIIa inhibitors

Procedural anticoagulation must consist of either bivalirudin with or without the addition of cangrelor (in which case GP IIb/IIIa inhibition is not recommended unless required for refractory procedural thrombotic complications) or heparin with either cangrelor or with routine use of a GP IIb/IIIa inhibitor. If a GP IIb/IIIa inhibitor is used, it should be continued during the SSO2 infusion and for a total of at least 12 hours post procedure, as per standard of care. Intravenous cangrelor may also be used according to label per physician discretion, administered as a bolus plus infusion, with the infusion continued for 2-4 hours post-PCI.

• If unfractionated heparin is selected, local dosing regimens may be used, although it is recommended that an initial bolus of 60 IU/kg is administered, followed by titration to the ACT of 200-250 seconds in patients receiving a GP IIb/IIIa inhibitor.
• If bivalirudin is selected as the procedural anticoagulant, it should be administered as a bolus of 0.75 mg/kg IV prior to PCI, followed by an infusion of 1.75 mg/kg/h initiated as soon as possible. Intravenous cangrelor may also be used according to label per physician discretion, administered as a bolus plus infusion, with the infusion continued for 2-4 hours post-PCI.
• Please refer to the Instructions for Use package insert for detailed instructions and a complete list of all contraindications, warnings, and precautions.
• For additional support, please contact our Technical Support Line: 1-800-699-4361. For Live Case Support, Press 1.

Caution: Federal (USA) Law restricts this device to the sale by or on the order of a physician.
ZOLL Medical Corporation • Chelmsford, MA, USA • 800-348-9011 • www.zoll.com
© 2020 ZOLL Medical Corporation. All rights reserved. TherOx and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All other trademarks are the property of their respective owners. MCN HP 2001 0375 30307-0001 Rev.1

References

• Medical Devices and Technology Solutions - ZOLL Medical

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