US-based medical device company TherOx has commenced an investigational device exemption (IDE) pilot study of its new supersaturated oxygen (SSO2) therapy device.

Using a catheter, the TherOx device delivers SSO2 therapy by mixing highly oxygenated saline with the patient’s blood to salvage damaged myocardium in patients with acute myocardial infarction (AMI).

The SSO2 therapy, which is designed as an alternative to percutaneous coronary intervention (PCI), reduces infarct size in the ischemic area of the heart and improves cardiac function, according to 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 demonstrated a relative reduction of 26% in infarct size, compared to PCI and stenting alone.

"Using a catheter, the TherOx device delivers SSO2 therapy by mixing highly oxygenated saline with the patient’s blood to salvage damaged myocardium in patients with acute myocardial infarction (AMI)."

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 towards 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 said.

In addition to Beaumont Health System, other US-based centres involved in the IDE study include Providence Hospital Cardiology in Detroit; Wellmont CVA Heart Institute at Holston Valley Medical Center in Kingsport, Tennessee and Scottsdale Heart Group in Scottsdale, Arizona.