FDA Approves Zoll Medical's Next-Generation TherOx System for LAD STEMI

March 30, 2020—Zoll Medical Corporation, an Asahi Kasei Group company, announced FDA approval of the second-generation TherOx system, which provides supersaturated oxygen (SSO2) therapy and reduces heart muscle damage in patients with left anterior descending ST-segment elevation myocardial infarction (LAD STEMI).

SSO2 therapy is indicated for patients experiencing LAD STEMI who are treated within 6 hours of symptom onset. The TherOx system delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization via angioplasty and stenting of the blocked coronary artery.

According to Zoll Medical, SSO2 therapy has been shown in prospective clinical trials to safely reduce infarct size in LAD STEMI patients, which is correlated with reduced mortality and heart failure, and improved left ventricular function.

In the company's announcement, Richard A. Schatz, MD, commented, "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. This can translate to heart failure prevention and patient survival." Dr. Schatz is Research Director, Cardiovascular Interventions, at Scripps Memorial Hospital in La Jolla, California.