TherOx, Inc, a privately held medical device company focused on the treatment of Acute Myocardial Infarction (AMI), has announced the initiation of its multicenter Investigational Device Exemption (IDE) pilot study of a second generation system.
This system delivers Supersaturated Oxygen (SSO2) Therapy for reduction of infarct size after an Acute Myocardial Infarction (AMI). SSO2Therapy is intended to provide interventional cardiologists with the first treatment option beyond percutaneous coronary intervention (PCI) to salvage heart muscle in heart attack patients.
The first patient was treated by Amr Abbas, MD, Director of Interventional Cardiology Research at Beaumont Hospital in Royal Oak, Michigan. Simon Dixon, MD, chair of cardiovascular medicine at Beaumont Hospital and an investigator for this study, was involved in the previous SSO2Therapy trial, AMIHOT II.
He noted, “During AMIHOT II, we found the infarct size reduction achieved by SSO2Therapy was clinically significant. Because of this, I believe SSO2therapy shows great potential in improving outcomes for high-risk patients.”
According to the American Heart Association, every year approximately one million people in the US have heart attacks. Although PCI is the standard of care in treating AMI, for many patients it doesn’t do enough to reduce infarct size and achieve maximum clinical benefit. SSO2Therapy, adjunctive to PCI, is a solution of highly oxygenated saline mixed with the patient’s blood delivered through a catheter to the targeted ischemic area of the heart. SSO2Therapy is intended to salvage the jeopardised myocardium and thus reduce infarct size.
“Randomised clinical studies show that final infarct size correlates with improved cardiac function as well as mortality in heart attack patients. Further reducing infarct size in heart attack patients is an unmet clinical need which SSO2Therapy may help address,” said Gregg W. Stone, MD, principal investigator of the SSO2Therapy IDE trial and professor of medicine at Columbia University Medical Center.
“This IDE study is an important milestone toward bringing SSO2 Therapy to the US market,” said Kevin T. Larkin, president and chief executive officer of TherOx. “This second generation system improves upon our previous system by making SSO2Therapy easier to administer in the cath lab, and we anticipate even better results than achieved in AMIHOT II.”