ZOLL Medical has received CE Mark approval to market and distribute its SuperSaturated oxygen (SSO2) therapy system in Europe. A press release reports that SSO2 therapy provides interventional cardiologists with the first and only clinically proven treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in myocardial infarction patients.
SSO2 therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularisation via angioplasty and stenting of the blocked coronary artery. It is indicated for patients who experience the most serious kind of myocardial infarction—left anterior descending ST-elevation myocardial infarction (LAD STEMI)—and who are treated within six hours of symptom onset. The press release states SSO2 therapy has been shown in prospective clinical trials to safely reduce infarct size in patients with this type of myocardial infarction. Research has demonstrated that infarct size reduction is correlated with reduced mortality and heart failure, and better left ventricular function.
Antonio L Bartorelli (Centro Cardiologico Monzino, University of Milan, Milan, Italy) says: “I am very happy to know that ZOLL received CE mark approval for the TherOx system. We were among the first in Europe to observe the beneficial impact of SSO2 therapy on left ventricular recovery after primary coronary intervention in patients with LAD STEMI and we look forward to being able to use this effective treatment again in our patients.”
SSO2 therapy is the first and only US Food and Drug Administration (FDA) approved device beyond PCI to reduce muscle damage in heart attack patients.