Learn more about the PROACT Study
Until the completion and analysis of study data, On-X Life Technologies, Inc. (On-X LTI), continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X® valve.
Other Non-Randomized Reduced Anticoagulation Trials in Progress
For the past year, a non-randomized observational study of On-X® valve patients under standard labeling indications with an INR target range within 'yet at the lower limits of' American College of Cardiology and American Heart Association guidelines, has been conducted by Cardiac Surgical Associates (CSA) and the Tampa Bay Heart Institute. The study employs home monitoring to aid control of the anticoagulant therapy. The study has not reached significance, but according to Vinay Badhwar, M.D., "the observed results of our non-randomized reduced anticoagulation trial with the On-X® valve are extremely encouraging. The lack of bleeding complications and the combination of a durable prosthesis with manageable low INR anticoagulation is providing patients with significant lifestyle improvements."
In South Africa, 438 On-X® valve patients have been followed (95 percent) for five years. The patients are documented to have varying amounts of anticoagulation. Approximately 14 percent of On-X® valve patients were categorized as having "unsatisfactory" or anticoagulation below 1.5 INR. Another 29 percent had "no" or "unknown" anticoagulation, which was attributed to poor patient compliance to established protocols. The remarkable aspect of the study is that among aortic, mitral and double valve replacement patients, only one (0.2 percent per patient year) patient experienced thrombosis.
More about the On-X® Prosthetic Heart Valve
The On-X® valve is the result of a breakthrough in medical grade carbon technology: On-X® Carbon. In addition to providing
a more thrombo-resistant surface, the pure On-X® Carbon enabled On-X LTI to make significant valve design changes that resulted
in a prosthetic valve that treats blood more like a natural valve. It is well documented that the On-X® valve does not
produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and therefore
significantly reduces the potential for life-threatening blood clots.
First implanted in 1996, recent clinical evidence suggests that patients implanted with the On-X® heart valve may be able to forego or reduce the dosages of anticoagulation therapy traditionally required by mechanical heart valve recipients.
The FDA approved the On-X® aortic and mitral valves for commercial use in the United States on May 30, 2001, and March 6, 2002, respectively. More than 40,000 On-X® valves have been implanted since 1996.
About Cardiovascular Disease and Heart Valve Replacement
Cardiovascular disease is the number one cause of death worldwide. The American Heart Association reports that 95,000
surgeries were performed in the United States to repair or replace malfunctioning or diseased heart valves in 2003.
According to a June 2004 report issued by Millennium Research Group, life-threatening heart valve disease, including
stenosis and regurgitation, affected approximately five million people in the United States in 2003. Millennium Research
Group predicts the heart valve market will generate more than $650 million by 2008 due to advances in minimally invasive
techniques, the increasing incidents of cardiovascular disease and the aging population.
About On-X LTI
On-X Life Technologies, Inc., (On-X LTI, formerly MCRI) develops heart valve replacements that significantly improve the quality of life for patients. Jack Bokros, Ph.D., and his associates founded MCRI in 1994 to advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The On-X® valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue Replacement Products category. On-X LTI also provides OEM services utilizing its patented On-X® Carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices. On-X LTI is headquartered in Austin, Texas, and maintains a wholly owned subsidiary, MCRI Deutschland GmbH, in Hannover, Germany. More information about the company is located at www.onxlti.com.
