Irvine, Calif.-based oxygenation therapy company TherOx said today it won FDA investigational device exemption approval to test its 2nd-generation Supersaturated Oxygen therapy system for treating acute myocardial infarction.
The company’s SSO2 therapy is designed to reduce infarct size by increasing oxygen delivery to heart muscle immediately after the coronary artery has been opened through a percutaneous coronary intervention procedure.
The system mixes highly oxygenated saline with a patient’s blood and delivers the mixture through a catheter to the targeted ischemic area of the heart, the company said.
“In multiple peer-reviewed studies, we have found the infarct size reduction achieved by SSO2 Therapy was clinically significant compared to PCI. I am excited about the potential that SSO2 therapy shows in improving outcomes for patients experiencing large anterior infarcts and treated within six hours of onset,” study investigator Simon Dixon of the Beaumont Hospital Royal Oak said in a press release.
The company is initiating a 100-patient study to support its premarket approval application to the FDA as it seeks clearance in the U.S.
“This IDE study is an important milestone toward bringing SSO2 Therapy to the U.S. market. Initiating this new study moves us another step closer to our goal of providing substantially better options for treating heart attack patients,” CEO Kevin Larkin said in prepared remarks.
TherOx’s 1st generation device received CE Mark approval in the European Union after meeting safety and effectiveness endpoints in a clinical trial which reported 26% reduction in infarct size compared to procedures using PCI and stenting alone, the company said.