TherOx has started an investigational device exemption (IDE) pilot study of its new supersaturated oxygen (SSO2) therapy device, designed to salvage damaged cardiac muscle in patients with acute myocardial infarction (AMI).
The TherOx device, which is designed as an alternative to percutaneous coronary intervention (PCI), uses a catheter to deliver SSO2 therapy by mixing highly oxygenated saline with the patient's blood.
The SSO2 therapy also reduces infarct size in the ischemic area of the heart and improves cardiac function, claims the company.
During the company's AMIHOT II trial, conducted at the US based Beaumont Hospital, the first generation SSO2 therapy device met the safety and effectiveness endpoints and showed a relative reduction of 26% in infarct size compared to PCI and stenting alone.
Beaumont Hospital cardiovascular medicine chair and study investigator Simon Dixon said significant reduction of infarct size shows great potential in improving outcomes for high-risk heart attack patients.
TherOx president and chief executive officer Kevin Larkin said the 20-patient based IDE study is an important milestone toward bringing SSO2 therapy to the US market.
"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," Larkin added.
In addition to Beaumont Health System, other US based centers involved in the IDE study include Providence Hospital Cardiology, Wellmont CVA Heart Institute at Holston Valley Medical Center and Scottsdale Heart Group.
