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June 14, 2001

Penn Participates in Trial of Stent Device Designed to Deliver Drugs to Reduce Re-clogging in Arteries

(Philadelphia, PA) - Stent implantation, or using a tube-like scaffold to reopen a blocked artery, has proven an effective way to reestablish blood flow in coronary artery disease. Unfortunately, restenosis - the re-clogging of arteries following stent surgery - affects up to 20 percent of all patients.

In an effort to find a solution to restenosis, physicians at the University of Pennsylvania Medical Center have performed studies in animals to help create a unique stent designed to deliver medications into the adjacent arterial wall. They are now participating in a human trial of this stent, designed to release a restenosis-preventing medication over time.

The SIRIUS Study is the first human trial of a coated stent: the Bx Velocity. The Bx Velocity functions like a normal stent, only it is covered with a medication called sirolimus, which has the potential to reduce the recurrence of symptoms after angioplasty in patients with blockages in their heart arteries.

"The stent releases the medication gradually over a period of 30 days - long enough to carry a patient through the critical time after the procedure when restenosis is likely to develop," said Robert L. Wilensky, MD, associate professor and director of Interventional Cardiology Research at the Penn Division of Cardiovascular Medicine Division.

The SIRIUS Study is a large, randomized, double-blinded clinical trial sponsored by Cordis, a Johnson & Johnson company. Cordis received approval on February 2, 2001 from the FDA to conduct the SIRIUS clinical trial.

Overall, the SIRIUS Study is designed to include 1,100 patients at 55 hospital centers across the United States. The clinical results of the study will be measured through on-going patient monitoring and review of angiographic follow-up. The study follows two pilot trials -totaling 45 patients - involving the Bx Velocity coated stent. In the pilot studies, there was no evidence of restenosis 12 months after the surgery or adverse events from the treatment.

"Using a stent to reopen a blocked cardiac artery is a well-established technique," said Wilensky, "and this device may solve stent implantation's biggest long-term problem."

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