News | Cath Lab | May 19, 2017

TherOx Completes Enrollment in IC-HOT Study of Supersaturated Oxygen Therapy System

Study of 100 patients will evaluate ability of next-generation TherOx system to improve acute myocardial infarction outcomes

TherOx Completes Enrollment in IC-HOT Study of Supersaturated Oxygen Therapy System

May 19, 2017 — TherOx Inc. announced that it completed enrollment in the IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study. IC-HOT is a confirmatory study of the second-generation TherOx system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction (AMI).

The IC-HOT study enrolled 100 patients and is being conducted to support a premarket approval submission to the U.S. Food and Drug Administration (FDA). The primary study objective 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.

“Since the advent of angioplasty and stenting to treat heart attack we haven't seen any new treatment options to reduce infarct size in this vulnerable population, and SSO2 therapy appears to fulfill this unmet need,” said Nainesh Patel, M.D., interventional cardiologist at Lehigh Valley Health Network and an investigator for the study.

According to the American Heart Association, every year nearly 1 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 gherapy treats patients who have experienced the most serious large anterior wall heart attacks — patients who often have poor outcomes even after successful intervention,” said Frances Wood, M.D., interventional cardiologist at WakeMed Heart and Vascular - Structural Heart and study investigator. “This therapy is a promising new tool to reduce infarct size and thus improve outcomes for these higher risk patients.”

SSO2 therapy is intended to provide interventional cardiologists with the first treatment option beyond PCI to salvage heart muscle in heart attack patients. 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 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:

Related Content

Videos | Cath Lab | March 15, 2018
A discussion with Hitinder Gurm, M.D., MBBS, FACC, professor, internal medicine, and associate chief clinical officer
News | Cath Lab | February 27, 2018
The American College of Cardiology (ACC) and the Saudi Arabian Cardiac Interventional Society have partnered to...
News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Overlay Init