Technology | Cath Lab | September 29, 2017

FDA Begins Final Review of TherOx SSO2 Therapy System

Oxygen therapy system is designed to improve outcomes for acute myocardial infarction patients

TherOx Gains FDA PMA Approval for SSO2 Therapy System

September 29, 2017 — TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the premarket approval (PMA) application for its Supersaturated Oxygen (SSO2) Therapy system. The second-generation SSO2 Therapy system is designed to reduce infarct size and thereby improve outcomes in anterior acute myocardial infarction (AMI) patients treated within six hours of symptom onset.

Although percutaneous coronary intervention (PCI) is the standard of care in treating AMI, for many patients it does not sufficiently reduce infarct size to achieve maximum clinical benefit. In SSO2 Therapy, the patient’s blood is supersaturated with oxygen and then returned directly to the targeted ischemic area of the heart through a small catheter. Adjunctive to PCI, SSO2 Therapy is intended to salvage heart muscle and reduce infarct size.

The PMA application includes data from the IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study, a confirmatory study that enrolled 100 patients at 15 investigational centers in the United States. The primary objective of the IC-HOT study was to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in the treatment of anterior ST-elevation AMI patients who have undergone successful PCI with stenting within six hours of experiencing AMI symptoms.

For more information: www.therox.com

Related Content

Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy
News | Cath Lab | September 03, 2019
Shockwave Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)...
Compound Could Help Improve Heart Attack Recovery
News | Cath Lab | August 27, 2019
Imagine there were a drug that you could take soon after a heart attack that could reduce damage by protecting healthy...
New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Overlay Init