ZOLL Medical Receives FDA IDE Approval for Initiation of ISO SHOCK (Incorporating Supersaturated Oxygen in Shock) Feasibility Study

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ZOLL Medical Corporation
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ZOLL MEDICAL RECEIVES FDA IDE APPROVAL FOR INITIATION OF ISO SHOCK (INCORPORATING SUPERSATURATED OXYGEN IN SHOCK) FEASIBILITY STUDY

 

   

May 13, 2021 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for a randomized prospective study evaluating the use of TherOx® SuperSaturated Oxygen (SSO2) Therapy in patients presenting with ST Elevation Myocardial Infarction (STEMI) and cardiogenic shock and treated concurrently with a mechanical circulatory support device. The ISO SHOCK study will assess the safety and feasibility of SSO2 Therapy in patients with this complex and highly fatal condition and potentially lay the groundwork for future trials to benefit high-risk heart attack patients.

Multiple clinical trials have demonstrated the efficacy of SSO2 Therapy to reduce infarct size resulting from high-risk heart attacks such as LAD-STEMI1,2,3 by delivering hyperoxemic levels of dissolved oxygen (7–10x normal) directly to damaged heart muscle immediately after percutaneous coronary intervention (PCI). The ISO SHOCK study will determine the safety and feasibility of delivering SSO2 Therapy to patients presenting with STEMI and cardiogenic shock, a subset of high-risk patients with a mortality rate between 40 and 60 %,4 compared to standard practice and outcomes demonstrated in the National Cardiogenic Shock Initiative (NCSI).

A STEMI heart attack is associated with a 2-fold increased risk of developing cardiogenic shock,5 a life-threatening condition in which the heart cannot pump adequate oxygenated blood to vital organs. Cardiogenic shock represents the highest risk category of STEMI with the greatest myocardial damage from ischemia. SSO2 Therapy could potentially mitigate damaged tissue while improving left ventricular structure and function in this complex patient population.

“Cardiogenic shock remains one of the most challenging diagnoses for interventional cardiologists to manage, especially in the setting of STEMI,” said William O’Neill, MD, Cardiologist at Henry Ford Health System and co-investigator of ISO SHOCK along with M. Babar Basir, MD. “I have utilized SSO2 Therapy in previous trials for anterior STEMI and seen positive results, and I think there is a significant potential benefit for this high-risk population as well.”

The ISO SHOCK study will randomize 60 patients in 20 sites across the U.S. to assess whether SSO2 Therapy could provide benefit to these complex patients compared to the current standard of care. The primary safety endpoint will assess mortality at 30 days with the SSO2 Therapy group compared to the control group as well as against the historical 32% mortality from the NCSI. The feasibility endpoints will measure completion of a 60-minute SSO2 infusion after successful PCI, and obtaining an MRI 3–7 days after PCI.

“SSO2 Therapy was designed to recover damaged myocardium in heart attack patients, with the intention of preventing devastating heart failure and potentially death,” added Neil Johnston, President of ZOLL Circulation. “The initiation of the ISO SHOCK trial for the sickest of these patients — those in cardiogenic shock — only reinforces our commitment to this cause.”

SuperSaturated Oxygen (SSO2) Therapy is the first and only FDA-approved treatment to significantly reduce cardiac muscle damage in heart attack patients after percutaneous coronary intervention.1 It is currently indicated for patients who suffer LAD STEMI and are treated within six hours of symptom onset.

SSO2 Therapy was developed by Irvine, California-based TherOx, Inc., now part of ZOLL Medical Corporation.

About ZOLL Medical Corporation

ZOLL Medical Corporation, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75
2 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405
3 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9
4 Kapur NK, et al. Methodist Debakey Cardiovasc J. 2020 Jan-Mar; 16:1:16–21
5 Vahdatpour C, et al. J Am Heart Assoc. 2019 Apr 16;8:8:e011991

Copyright © 2021 ZOLL Medical Corporation. TherOx and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

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