US-based medical device company TherOx has successfully completed the patient enrollment in its multicenter investigational device exemption (IDE) pilot study to evaluate the second generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction (AMI).
SSO2 therapy is a new therapy that complements percutaneous coronary intervention (PCI) in recovering heart muscle in heart attack patients.
Columbia University Medical Center professor of medicine and principal investigator of SSO2 therapy IDE trial Dr Gregg W Stone noted final infarct size correlates with improved cardiac function and mortality in heart attack patients, as demonstrated by several randomized clinical studies.
"Additional reduction of infarct size is an unmet clinical need that SSO2 Therapy may help address," Dr Stone added.
TherOx president and CEO Kevin T Larkin noted the pilot phase of the multi-center IDE study enrolled 20 patients at three prominent cardiac centers in the US.
"We appreciate the cardiology community’s enthusiasm to evaluate the potential benefits of the next generation system to deliver SSO2 Therapy," Larkin added.