First to cut infarct size since PCI
The FDA approved SuperSaturated Oxygen (SSO2) therapy to reduce cardiac infarct size in left anterior descending ST-elevation myocardial infarction (LAD STEMI, sometimes called "the widowmaker") within 6 hours of symptom onset, TherOx announced.
The company called it the first treatment other than percutaneous coronary intervention (PCI) to significantly reduce heart attack muscle damage.
TherOx said the one-time treatment consists of a 60-minute infusion of the patient's own blood superoxygenated to hyperbaric levels, delivered directly to the ischemic heart muscle via catheter immediately after reopening the LAD artery with angioplasty and stenting.
Approval was based on a 26% relative reduction in infarct size seen with SSO2 in the pivotal randomized controlled trial compared with PCI alone.
"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," said Gregg W. Stone, MD, of Columbia University Medical Center in New York City, in TherOx's press release. "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."
Read the original article on Medpage Today: 'Widowmaker' Heart Attack Tx Approved