FDA Approves Next-Generation ZOLL® TherOx System for Widowmaker Heart Attack Patients

March 30, 2020 |

4 min read

March 30, 2020 13:23 UTC FDA Approves Next-Generation ZOLL ® TherOx System for Widowmaker Heart Attack Patients First and Only Treatment to Reduce Heart Muscle Damage Following Angioplasty and Stenting CHELMSFORD, Mass.--( BUSINESS WIRE )-- ZOLL ® Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced today it has received U.S. Food and Drug Administration (FDA) approval of the second-generation Ther

March 30, 2020 13:23 UTC

FDA Approves Next-Generation ZOLL^® TherOx System for Widowmaker Heart Attack Patients

First and Only Treatment to Reduce Heart Muscle Damage Following Angioplasty and Stenting

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced today it has received U.S. Food and Drug Administration (FDA) approval of the second-generation TherOx System, which provides SuperSaturated Oxygen (SSO₂) Therapy and reduces heart muscle damage in “widowmaker” heart attack patients.¹

“The TherOx SSO₂ Therapy system is another example of ZOLL’s commitment to technology that provides advanced clinical performance to improve outcomes,” said Neil Johnston, President, ZOLL Circulation. “We are pleased to provide the interventional cardiologist with a new treatment that augments the standard of care for patients.”

SSO₂ Therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization via angioplasty and stenting of the blocked coronary artery. It is indicated for patients who suffer the most serious kind of heart attack — left anterior descending ST-elevation myocardial infarction (LAD STEMI), also known as a “widowmaker” due to the high mortality rate — and who are treated within six hours of symptom onset. SSO₂ Therapy is the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to reduce muscle damage in heart attack patients.²

“SSO₂ Therapy is the only point-of-care treatment for LAD STEMI patients which results in a predictable reduction in infarct size and improved left ventricular function^1,5” said Richard A. Schatz, MD, Research Director, Cardiovascular Interventions, at Scripps Memorial Hospital in La Jolla, CA. “This can translate to heart failure prevention and patient survival.”

Historically, angioplasty and stenting have been the standard of care in treating heart attacks. Many patients do not achieve maximum clinical benefit and suffer from reduced heart function. More than 30% of severe heart attack patients develop heart failure,³ and of those, 50% will die within five years.³ SSO₂ Therapy has been shown in prospective clinical trials to safely reduce infarct size in “widowmaker” heart attack patients⁵. Decades of research on heart attack patients has demonstrated that infarct size reduction is correlated with reduced mortality and heart failure, and better left ventricular function.⁴

SSO₂ Therapy was developed by Irvine, California-based TherOx, Inc., now part of ZOLL Medical Corporation. Additional information about SSO₂ Therapy is available at https://www.therox.com/sso2-therapy.

About ZOLL Medical Corporation

ZOLL Medical Corporation, an Asahi Kasei Group 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 monitoring, circulation and CPR feedback, data management, fluid resuscitation, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com.

About Asahi Kasei

The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corporation, with operations in the material, homes, and health care business sectors. 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. With more than 40,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.

¹Stone GW, et al. Circ Cardiovasc Intervent 2009;2:5:366–375.
²Martin JL. Cardiac Interventions Today. 2019;13:4:28–30.
³Heart Failure Fact Sheet|Data & Statistics|DHDSP|CDC
⁴Stone, G.W. et al. J Am Coll Cardiol. 2016;67(14):1674–83.
⁵David SW, et al. Catheter Cardiovasc Interv. 2018;1–9.

©2020 ZOLL Medical Corporation. All rights reserved. TherOx and ZOLL are trademarks and/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.