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MEDIA RELEASE

CONTACT:
Cindy Ficorelli
Phone: (810) 606-6270
Fax: (810) 606-6279
caficorelli@genesys.org

02/16/2004

Genesys chosen as testing site for new heart stent system

(Editor's note: if you would like to interview David Dobies, MD, FACC, interventional cardiologist and principal investigator of the study at Genesys, please call the Marketing department at 606-7399.)
(GRAND BLANC, MI) Boston Scientific, a worldwide developer, manufacturer and marketer of medical devices, has chosen the Genesys Heart Institute as the only health system in Michigan to serve as a clinical study site for a new stent called the TAXUS Express paclitaxel-eluting coronary system. Only 50 centers in the country were selected to participate.

The US Food and Drug Administration (FDA) has approved this clinical trial of some 2,000 patients nationwide. Hospitals began enrolling patients as recently as last week.

According to TAXUS studies conducted in Europe, this new stent "provides excellent target lesion revascularization and a huge reduction in restenosis cases," reports David Dobies, MD, FACC, interventional cardiologist at the Genesys Heart Institute who serves as the principal investigator of the study at Genesys.

In addition to its outstanding outcomes for patients with heart disease, the new stent is easier and safer to use than previous stent devices, Dr. Dobies notes. The laser-bonded trak tip provides a precise smooth insertion through the natural contour of the heart vessels, he adds.

The study is designed to collect and analyze "real world" safety and clinical outcomes when treating patients with coronary artery disease.

National co-principal investigators are David Cox, MD, from Mid Carolina Cardiology in Charlotte, North Carolina; and John Nasala, MD, PhD; from the Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, Missouri. Dr. Cox enrolled the first patients in the US on Feb. 4.

Genesys conducted its first case Monday, Feb. 16.

The Genesys Heart Institute has been involved in other heart clinical trials. The health system is the first one in Michigan and the 16th in the US to use a new investigational endovascular device that induces mild hypothermia to reduce heart muscle damage during a heart attack. The ICE-IT clinical trial (intravascular cooling adjunctive to primary coronary intervention) involves lowering the patient's body temperature to about 91.4 degrees to minimize or halt damage to the heart," says Dr. Dobies. The procedure must be conducted within six hours of a heart attack to minimize irreversible cardiac tissue damage that can occur. Pilot studies of ICE-IT have shown mild hypothermia has the potential to protect injured heart tissue and minimize heart muscle damage.

Genesys is one of only four hospitals in Michigan and one of 28 nationwide participating in an international heart research study to determine if angioplasty or heart medication is more effective in treating elderly patients who have suffered a heart attack. Results of this study "will help hospitals worldwide determine the best method for treating this rapidly growing population," Dr. Dobies points out.

The Genesys Heart Institute also was selected as a national training site for radial artery harvesting, an FDA-approved minimally invasive procedure to obtain an artery from the arm for bypass surgery. The radial artery is more durable than an artery from the leg. Heart surgeons and physician assistants from across the country travel to Genesys to learn this harvesting technique.

Consumers, for the third consecutive year, have named Genesys the hospital of choice for heart care. Blue Cross of Blue Shield of Michigan has designated Genesys as a "center of excellence" in cardiac care for the past four years.

Most recently, HealthGrades, a national quality rating organization, gave Genesys a five star rating (the highest possible) for clinical performance in cardiac services. Fewer than 15 percent of all hospitals in the country earn this distinction. For the last three years HealthGrades ranked Genesys in the top 10 percent of hospitals in the country for overall cardiac services.

For more information on the TAXUS study or other Genesys Heart Institute services, call the Marketing department at (810) 606-6270.

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