TherOx has received premarket approval from the US Food and Drug Administration (FDA) for its SuperSaturated Oxygen (SSO2) therapy to reduce infarct size in heart attack patients.
The therapy is said to be the first FDA-approved heart attack treatment since percutaneous coronary intervention (PCI), which has been the standard of care for acute myocardial infarction (AMI) for more than two decades.
SSO2 is indicated for the treatment of left anterior descending ST-elevation myocardial infarction (LAD STEMI) within six hours of symptom onset. It involves direct delivery of hyperbaric oxygen to the ischemic heart muscle via a single catheter-delivered infusion, which is administered immediately following the opening of the coronary artery by PCI.
This therapy is given adjunctively, immediately after stent placement.
In various clinical trials, SSO2 demonstrated a consistent and safe reduction in infarct size in patients with anterior AMI. A pivotal randomised controlled trial showed a 26% relative reduction in infarct size, when compared to PCI alone.
TherOx noted that infarct size reduction is linked to improved patient outcomes, including a reduction in future heart failure.
Additional study findings indicate left ventricular stability at 30 days without deleterious enlargement.
TherOx president and CEO Kevin Larkin said: “We have repeatedly demonstrated that SSO2 therapy significantly reduces infarct size among patients who suffer from large anterior AMIs, which are the most serious of 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.”
American Heart Association’s statistics reveal that around 750,000 people in the US experience a heart attack each year. More than 30% of severe AMI patients are known to develop heart failure. Around 50% of these have a survival rate of less than five years.