ZOLL Medical receives FDA approval for TherOx System
08 April 2020
ZOLL Medical has received approval from the US Food and Drug Administration (FDA) for its TherOx System that delivers SuperSaturated Oxygen (SSO2) Therapy and reduces heart muscle damage in ‘widowmaker’ heart attack patients.
SSO2 Therapy provides hyperbaric levels of oxygen directly to the damaged heart muscle soon after successful revascularisation through angioplasty and stenting of the blocked coronary artery. The therapy is suitable for patients with left anterior descending ST-elevation myocardial infarction (LAD STEMIan) and for those who are treated within six hours of symptom onset.
LAD STEMIan is also known as ‘widowmaker’ due to a high mortality rate. It is considered one among the most fatal heart attacks. ZOLL Circulation president Neil Johnston said: “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.” Considered to be the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI), the therapy reduces muscle damage in heart attack patients. Angioplasty and stenting, the standard care for heart attacks, do not provide maximum clinical benefit to the patients.
In addition, more than 30% of severe heart attack patients develop heart failure, while 50% among them die within five years. SSO2 Therapy is the only point-of-care treatment for LAD STEMI patients that results in a predictable reduction in infarct size and improved left ventricular function. In prospective clinical trials, it has safely reduced infarct size in ‘widowmaker’ heart attack patients.
Published by medicaldevice-network.com on March 31, 2020
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