Zoll Medical wins FDA nod for second-gen TherOx system

Zoll Medical Corp. announced today that it received FDA approval for its second-generation TherOx system for SuperSaturated Oxygen (SSO₂) therapy in heart attack patients.
The Chelmsford, Mass.–based company’s TherOx system is designed to deliver the SSO₂ therapy that has been shown in clinical trials to reduce infarct size (heart muscle damage) in “widowmaker” heart attack patients, which is correlated with reduced mortality and heart failure as well as better left ventricular function, according to a news release.
SSO₂ therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization by way of angioplasty and stenting of the blocked coronary artery. This type of therapy is indicated for people who suffer the most serious kind of heart attack and are treated within six hours of symptom onset.
Zoll touts SSO₂ therapy as the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) for reducing muscle damage in heart attack patients.
“The TherOx SSO₂ therapy system is another example of Zoll’s commitment to technology that provides advanced clinical performance to improve outcomes,” Zoll circulation president Neil Johnston said in the release. “We are pleased to provide the interventional cardiologist with a new treatment that augments the standard of care for patients.”
Zoll completed the acquisition of Irvine, Calif.-based TherOx and its acute myocardial infarction treatment for an undisclosed amount in June 2019.
Original Article: (https://www.massdevice.com/zoll-medical-wins-fda-nod-for-second-gen-therox-system/)