Hospital first to use FDA-approved oxygen therapy device for patients with widowmaker heart attacks

Jan. 15, 2020

ZOLL Medical Corporation announced that Scripps Memorial Hospital La Jolla treated its first "widowmaker" heart attack patient with SuperSaturated Oxygen (SSO2) Therapy. This is the first-of-a-kind FDA-approved device proven through randomized clinical trials to reduce heart muscle damage. SSO2 Therapy was developed by Irvine, California-based TherOx, Inc., a subsidiary of ZOLL Medical Corporation.

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 are treated within six hours of symptom onset. SSO2 Therapy is the first and only FDA-approved device beyond percutaneous coronary intervention (PCI) to reduce muscle damage in heart attack patients.

"These most serious heart attacks often cause such severe damage to the heart that even if the patient survives, they remain at high risk for developing heart failure in the future," said Richard Schatz, MD, Research Director Cardiovascular Interventions, Scripps Clinic. "The use of hyperbaric oxygen is well known to improve the body's ability to heal, and similar clinical data in the heart have demonstrated the ability of SSO2Therapy to reduce tissue damage and thus reduce future complications."

A heart attack is typically caused when the flow of blood and oxygen to the heart is blocked or reduced. For many patients, even after blood flow is quickly restored with angioplasty and stenting, irreversible damage to the heart muscle may occur. SSO2 Therapy delivers localized superoxygenated blood, with the goal of improving microvascular blood flow and reducing damage to the heart muscle.

Although angioplasty and stenting have been the standard of care in treating heart attacks for 25 years, many patients do not achieve maximum clinical benefit and suffer from reduced heart function. More than 30% percent 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 randomized prospective clinical trials to safely reduce infarct size in widowmaker heart attack patients. 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

ZOLL has the announcement.