Zoll has received FDA approval of the second-generation TherOx system, which—a press release reports—provides super-saturated oxygen (SSO2) therapy. SSO2 therapy is designed to deliver hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularisation via angioplasty and stenting of the blocked coronary artery.
The press release states that the therapy is indicated for patients who have the most serious kind of myocardial infarction—left anterior descending ST-segment elevation myocardial infarction (STEMI) and who are treated within six hours of symptom onset. It adds that a left anterior descending STEMI is also known as a “widowmaker” because of its associated high mortality rate. SSO2 therapy is the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to reduce muscle damage in heart attack patients.
Neil Johnston, president, Zoll Circulation, comments: “The TherOx SSO2 therapy system is another example of Zoll’s commitment to technology that provides advanced clinical performance to improve outcomes. We are pleased to provide the interventional cardiologist with a new treatment that augments the standard of care for patients.”
Richard A Schatz (Scripps Memorial Hospital, La Jolla, USA) says: “SSO2 therapy is the only point-of-care treatment for left anterior descending STEMI patients, which results in a predictable reduction in infarct size and improved left ventricular function. This can translate to heart failure prevention and patient survival.”