Healthcare Industry News: acute myocardial infarction
News Release - November 4, 2013
Supersaturated Oxygen Therapy IDE Study Results in Smaller Infarct Size for Next-Generation SystemTherOx Study Results Presented at TCT 2013
IRVINE, Calif.--(Healthcare Sales & Marketing Network)--TherOx, Inc., a privately held medical device company focused on the treatment of acute myocardial infarction (AMI), released results from the company's multicenter Investigational Device Exemption (IDE) pilot study that showed a 9.6% infarct size at 30 days in high-risk patients treated with its next-generation system for Supersaturated Oxygen (SSO2) Therapy. This groundbreaking 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 SSO2 system shows great potential in improving upon the earlier successful results of a first-generation system. Patients treated with the second-generation SSO2 Therapy system had a 9.6% median infarct size measured at 30 days. In a previous prospective, multi-center, randomized IDE trial, AMIHOT II, patients treated with the first-generation SSO2 system had a 20% infarct size, and control group patients treated with PCI alone had a 26.5% median infarct size. The pilot IDE study enrolled 20 patients at three prominent cardiac centers in the U.S.
“In the successful AMIHOT II study performed with the prior system, SSO2 Therapy was proven to reduce median infarct size by 26%, 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 one million people in the U.S. 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.
“We’re very pleased with the data and we believe it moves us another step closer to our goal of providing substantially better options for treating heart attack patients,” said Kevin T. Larkin, president and chief executive officer of TherOx.
About SSO2 Therapy
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 adjunctive to PCI and is intended to salvage the jeopardized myocardium and thus reduce infarct size, which correlates with improved cardiac function and mortality in heart attack patients.
A heart attack is typically caused when blood and oxygen flow to the heart is blocked or reduced. If not quickly restored, irreversible damage to the heart muscle, or infarction, will occur. SSO2 Therapy is designed to reduce infarct size by boosting oxygen delivery to the heart muscle immediately after the coronary artery has been opened by PCI. The TherOx system creates SSO2 Therapy by mixing highly oxygenated saline with the patient’s blood and delivers it through a catheter directly to the targeted ischemic area of the heart.
The first generation system to deliver SSO2 Therapy received the CE Mark and was successful in meeting the safety and effectiveness endpoints in the AMIHOT II trial. Statistical results from the AMIHOT II trial of SSO2 Therapy, together with PCI and stenting, demonstrated a relative reduction of 26% in infarct size compared to PCI and stenting alone. In addition, the finding of device effectiveness was supported by additional analyses that showed a 53% increased likelihood of having a small (less than 5% damage of the left ventricle) infarct among SSO2 Therapy patients. The results were published in Circulation: Cardiovascular Interventions.1
This second-generation system builds on the success of AMIHOT II and includes the additional benefits of shortening the treatment time to 60 minutes and broadening the treatment area to the entire left coronary system so that no ischemic area goes untreated. SSO2 Therapy is consistent with the 90-minute “door to balloon” initiative and supports the current guidelines for interventional cardiology procedures.
About TherOx, Inc.
TherOx is a privately held medical device company based in Irvine, Calif., focused on developing and commercializing SSO2 Therapy for this sizeable patient population to save hearts, and ultimately save lives. The major investors in TherOx include Kleiner Perkins Caufield & Byers, New Science Ventures, Integral Capital Partners, Aperture Venture Partners, DAG Ventures, and Cross Creek Capital. For more information about TherOx, visit http://www.therox.com.
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.
1 Stone GW, Martin JL, Boer MJ, et al. Effect of Supersaturated Oxygen Delivery on Infarct Size After Percutaneous Coronary Intervention in acute myocardial infarction. Cir Cardiovasc Interv 2009;2:366-75.
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