News | Cath Lab | February 22, 2016

TherOx Enrolls First Patient in Supersaturated Oxygen Therapy Study

IC-HOT study will evaluate safety and effectiveness of SS02 therapy in reducing infarct size for acute myocardial infarction patients

TherOx, IC-HOT study, supersaturated oxygen, SSO2 therapy, acute myocardial infarction, AMI

February 22, 2016 — TherOx Inc. announced the first patient has been enrolled in an Investigational Device Exemption (IDE) confirmatory study of its second-generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction (AMI). This study is being conducted to support a premarket approval submission to the U.S. Food and Drug Administration (FDA).

“Many heart attack patients suffer from large anterior infarcts after angioplasty and stenting, which carry a poorer prognosis in terms of mortality and the potential for future heart failure,” said Shukri David, M.D., FACC, physician chair of the Heart & Vascular Center of Excellence at St. John Providence Health System near Detroit, Mich., and an investigator for this study. “This important study of SSO2 therapy may provide physicians with an additional intervention that further improves outcomes for our heart attack patients.”

Called the IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study, it will enroll 100 subjects at up to 15 investigational centers in the United States. The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 therapy in treatment of anterior AMI patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.

According to the American Heart Association, every year nearly one million people in the United States have heart attacks. Although PCI is the standard of care in treating AMI, for many patients it doesn’t do enough to reduce infarct size and achieve maximum clinical benefit.

SSO2 therapy is intended to provide interventional cardiologists with the first treatment option beyond PCI to salvage heart muscle in heart attack patients.  SSO2 therapy, adjunctive to PCI, is a solution of highly oxygenated saline mixed with the patient’s blood delivered through a catheter to the targeted ischemic area of the heart. The therapy is intended to salvage the jeopardized myocardium and thus reduce infarct size. Multiple peer-reviewed studies have demonstrated the infarct size reduction achieved by SSO2 therapy was clinically significant compared to PCI alone.  

For more information: www.therox.com

Related Content

Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
Overlay Init