The Heart and Vascular Institute at McKay-Dee Hospital Center to participate in international heart valve clinical trial

Chris Dallin

 (801) 387-7750

 Chris.Dallin@imail.org

 7/16/2010

New heart valve technology may provide improved quality of life for heart valve recipients

Ogden-based Heart and Vascular Institute at McKay-Dee Hospital, announced recently that it will be one of 15 institutions around the world to test whether a new innovative heart valve can provide an improvement in the quality of life for heart valve recipients. The valve is the creation of a team of bio-engineers lead by heart valve pioneer Jack Bokros, PhD, called the On-X Prosthetic Heart Valve.

Replacement of an aortic valve is a common surgical intervention performed in nearly 1,000 institutions and for approximately 80,000 patients in the U.S. each year. Most patients face a challenging decision of whether to have a biologic (animal tissue) valve or a mechanical valve implanted. Biologic valves have a finite life expectancy of approximately 10-15 years thereby requiring recipients to have the valve replaced and face the risks of another major operation. On the other hand patients who select mechanical valves rarely face re-operation.

The study being conducted at McKay-Dee Hospital, the Prospective Randomized On-X SJM Evaluation, or PROSE Study, will help to determine how the On-X valve compares on quality of life metrics to the older generation mechanical heart valves.

Michael H. Buch, MD Primary Investigator for the PROSE study at McKay-Dee Hospital notes: "It is important that we continue to bring the latest in technology to our patients in this area. The PROSE study was organized and conducted by one of the world's most experienced valve researchers, Eric Jamison, MD, of the Vancouver British Columbia University. It is gratifying that The McKay-Dee Hospital's experience is being included in this important research."

"We began implanting the On-X valve a few years ago based upon the request of local patients and after extensive study of this new technology," notes David R. Goff, MD of McKay-Dee Hospital. "We have been pleased with the valve's performance thus far and are happy that patients are receiving the valve they consider consistent with their life choices."

The On-X valve has been FDA approved for use in the U.S. since 2002. There have been approximately 100,000 implants world-wide. The valve is presently the subject of the PROACT trial being conducted in 40 Institutions in the US including Emory University and The Cleveland Clinic. The PROACT trial will determine if the On-X valve may be maintained in some patients without the use of Warfarin, an anticoagulation drug.

Clyde Baker, President and CEO of On-X Life Technologies, Inc. and former Ogden resident notes "It is gratifying to be associated with this new heart valve technology which appears to provide such meaningful benefits to patients and to be able to work with the professionals at the McKay-Dee Heart and Vascular Institute. It is an additionally wonderful coincidence that we have the opportunity to have a portion of this study conducted in my hometown of Ogden Utah.


About Intermountain McKay-Dee Hospital Center
Intermountain McKay-Dee Hospital Center is a center of extraordinary care in the community. Announced as a Top 100 Hospital by Thomson Reuters, McKay-Dee Hospital is part of the Intermountain Healthcare system in Utah, the hospital was founded by Annie Taylor Dee in 1910 and continues to provide high-tech service with personalized care, regardless of the patient's ability to pay. McKay-Dee Hospital Center is a not-for-profit, 352-bed, full-service tertiary and acute care referral center located in Ogden, Utah. McKay-Dee Hospital's new facility that opened in 2002 is recognized as one of the finest facilities in the country. The Hospital offers the latest in diagnostics, surgery and medicine while integrating light, color, sound, and way-finding to provide a comfortable healing environment for patients and their family members.

With its affiliated clinics and medical staff, McKay-Dee Hospital Center provides nearly every specialty and the best options for care, making it possible to get world-class treatment without having to travel outside of the community.

About On-X Life Technologies, Inc.
On-X LTI develops heart valve replacements that significantly improve the quality of life for patients. The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. The company 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 was founded in 1994 by a team of heart valve material and design scientists and engineers led by pioneer Jack Bokros, PhD. Capitalizing on more than 30 years of heart valve design experience, the team developed and continues to manufacture the On-X Prosthetic Heart Valve. The valve is approved for use within the U.S. and throughout the world. On-X LTI is headquartered in Austin, Texas. More information is located on the On-X Life Technologies website, at: www.onxlti.com.

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