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: www.therox.com

Related Content

News | Heart Failure| May 22, 2017
Serelaxin failed to meet the primary endpoints of the phase 3 RELAX-AHF-2 trial, according to late-breaking results...
Consumers Warned About Accuracy of Heart Rate Apps in New Study
News | Mobile Devices| May 22, 2017
May 22, 2017 — Consumers are being warned about the accuracy of heart rate apps after a study found huge variability
Abbott recalls its NC Balloon catheters
News | Balloon Catheter| May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Biosense Webster multi-electrode RF ablation balloon

Biosense Webster's multi-electrode RF ablation balloon with irrigation. The system allows operators to change the energy levels of each electrode to avoid damaging sensitive underlying critical structures like the esophagus or phrenic nerve.

Feature | Ablation Systems| May 17, 2017 | Dave Fornell
May 17, 2017 – Clinical trial results from a first-in-human study evaluating the acute feasibility of an investigatio
Spectranetics Bridge Occlusion Balloon in the SVC

An illustration of how the Bridge balloon can seal the SVC after an accidental tear from lead extration.

Feature | EP Lab| May 17, 2017 | Dave Fornell
May 17, 2017 — A new intravenous occlusion balloon designed to seal any accidental tears in the superior vena cava (S
Contego Medical Receives CE Mark for Vanguard IEP Peripheral Balloon Angioplasty System
News | Peripheral Arterial Disease (PAD)| May 17, 2017
Contego Medical LLC announced recently that it has received CE Marking of its Vanguard IEP Peripheral Balloon...
Early Treatment for NSTEMI Patients Shows Greater Rate of Survival
News | Cath Lab| May 16, 2017
An analysis of non ST-elevation myocardial infarction (NSTEMI) patients who undergo coronary revascularization within...
micra leadless pacemaker
Feature | Pacemakers| May 16, 2017
May 16, 2017 - The preliminary results for the Medtronic Micra Transcatheter Pacing System (TPS) Post-Approval Regist
Medtronic Reveal Linq implantable cardiac monitor

The Medtronic Reveal Linq implantable cardiac monitor is the smallest implantable monitor on the market. It is used as a long-term Holter monitor for 24-hour a day, 365-day a year patient monitoring. The device uses wireless connectivity to download the patient data with a patient bedside base unit to send the information over the internet so it is accessible by physicians.

Feature | Atrial Fibrillation| May 16, 2017
May 16, 2017 - The study using small, subcutaneous implantable cardiac monitors for long-term, 24-hour a day monitori
Overlay Init