TherOx has received US FDA premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. A press release reports that SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in myocardial infarction patients.
The press release adds that SSO2 Therapy delivers hyperbaric levels of oxygen directly to the ischaemic heart muscle immediately after the coronary artery has been successfully opened by PCI (angioplasty and stenting). It is indicated for patients who have the most serious kind of myocardial infarctions—left anterior descending ST-segment elevation myocardial infarction (STEMI), which is also known as the “widowmaker”—treated within six hours of symptom onset. SSO2 Therapy is adjunctively administered immediately following successful stent placement, with no delay in PCI treatment.
Gregg W Stone (Columbia University Medical Center, New York, USA), says: “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. SuperSaturated Oxygen is the only therapy shown in a pivotal randomised 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.”
According to the press release, SSO2 Therapy has been shown in multiple randomised prospective clinical trials to consistently and safely reduce infarct size in anterior acute myocardial infraction patients and thereby improve outcomes. A pivotal randomised controlled trial demonstrated a 26% relative reduction in infarct size compared to PCI alone. Additional clinical trial data show left ventricular stability at 30 days with no deleterious enlargement.
Kevin T Larkin, president and chief executive officer of TherOx, says: “We have repeatedly demonstrated that SSO2 Therapy significantly reduces infarct size among patients who suffer from large anterior acute myocardial infarctions, which are the most serious heart attacks. 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.”