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

ZOLL^® Medical Corporation 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

References

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.