TherOx wins FDA approval for SuperSaturated Oxygen therapy

TherOx said today that it won pre-market approval from the FDA for its SuperSaturated Oxygen Therapy system for acute myocardial infarction.

Irvine, Calif.-based TherOx touted the PMA as the first heart attack treatment approved to reduce infarct size since the federal safety watchdog OK’d percutaneous coronary interventions.

Indicated for patients suffering from left anterior descending ST-elevation myocardial infarction – the most deadly form of heart attack, known colloquially as the “widowmaker” – within six hours of onset and after stenting, SSO₂ therapy delivers hyperbaric levels of oxygen directly to heart muscle tissue that’s denied blood flow during the attack.

“We have repeatedly demonstrated that SSO₂ therapy significantly reduces infarct size among patients who suffer from large anterior AMIs, which are the most serious heart attacks,” president & CEO Kevin Larkin said in prepared remarks. “This FDA approval enables interventional cardiologists to provide the most advanced care available to further reduce infarct size, prevent heart failure and ultimately save lives.”

“Even after angioplasty with stenting, many heart attack patients suffer from irreversible damage to the heart muscle, which carries a poor prognosis in terms of mortality and the potential for future heart failure,” added Dr. Gregg Stone of New York City’s Columbia University Medical Center. “SuperSaturated Oxygen is the only therapy shown in a pivotal randomized trial to reduce infarct size in patients with large anterior myocardial infarction, offering the potential to further improve outcomes in these high-risk patients despite successful primary angioplasty.”

TherOx said a pivotal trial showed a 26% relative reduction in infarct size compared to PCI alone and left ventricular stability at 30 days with no adverse infarct enlargement.

from MassDevice https://ift.tt/2K5vYeI