News | December 12, 2013

Supersaturated Oxygen Therapy IDE Study Results in Smaller Infarct Size for Next-Generation System

TherOx Study Results Presented at TCT 2013

December 12, 2013 – TherOx Inc. released results from the company's multicenter investigational device exemption (IDE) pilot study that showed a 9.6 percent smaller infarct size at 30 days in high-risk patients treated with its next-generation system for Supersaturated Oxygen (SSO2) Therapy. This new therapy is intended to provide interventional cardiologists with the first treatment option beyond percutaneous coronary intervention (PCI) to salvage heart muscle in heart attack patients. The study results were presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The next-generation SSOsystem shows great potential in improving upon the earlier successful results of a first-generation system. Patients treated with the second-generation SSO2Therapy system had a 9.6 percent median infarct size measured at 30 days. In a previous prospective, multi-center, randomized IDE trial, AMIHOT II, patients treated with the first-generation SSO2system had a 20 percent infarct size, and control group patients treated with PCI alone had a 26.5 percent median infarct size. The pilot IDE study enrolled 20 patients at three prominent cardiac centers in the United States.

“In the successful AMIHOT II study performed with the prior system, SSO2 Therapy was proven to reduce median infarct size by 26 percent, which is statistically significant. The new SSO2 system shows promise in producing even better results,” said Shukri David, MD, FACC, section chief of the division of cardiology at Providence Hospital near Detroit and the investigator for this study who presented the results at TCT.

The second-generation SSO2 Therapy system was designed to improve therapeutic effectiveness by perfusing the entire left coronary system so that no ischemic area goes untreated.  It also offers the additional benefit of shortening the treatment time to 60 minutes from 90 minutes. The original system only perfused the target artery treated with angioplasty and stenting.

According to the American Heart Association, every year approximately 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 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. SSO2 Therapy is intended to salvage the jeopardized myocardium and thus reduce infarct size, which correlates with improved cardiac function and mortality in heart attack patients. 

In the United States, SSO2 Therapy is delivered by an investigational device. It is limited by United States law to investigational use.  It is not for sale or distribution in the United States.

For more information:

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init