Therox has announced the initiation of its multicentre investigational device exemption (IDE) pilot study of a second generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction.
A company press release reported that SSO2 therapy 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, director of Interventional Cardiology Research at Beaumont Hospital in Royal Oak, USA. Simon Dixon, chair of cardiovascular medicine at Beaumont Hospital and an investigator for this study, was involved in the previous SSO2 Therapy trial, AMIHOT II. He noted, “During AMIHOT II, we found the infarct size reduction achieved by SSO2 therapy was clinically significant. Because of this, I believe SSO2 therapy shows great potential in improving outcomes for high-risk patients.”
“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 SSO2 Therapy easier to administer in the cath lab, and we anticipate even better results than achieved in AMIHOT II.”
The pilot phase of the IDE study will enroll 20 patients in the USA.