Healthcare Industry News:  self-expanding 

Devices Interventional

 News Release - September 12, 2006

First Patient Enrolled in First U.S. Study of Stent Placement to Treat Blockages Below the Knee

Study to Evaluate Xpert(TM) self-expanding Stent System From Abbott Vascular

SAN JOSE, Calif., Sept. 12 (HSMN NewsFeed) -- The El Camino Hospital in Mountain View, Calif., has enrolled the first patient in the XCELL clinical trial, the first U.S. study to evaluate Abbott Vascular's Xpert(TM) self- expanding stent in blood vessels below the knee for the treatment of severe peripheral arterial disease (PAD). The study, which was recently cleared by the U.S. Food and Drug Administration (FDA), is sponsored by VIVA Physicians, Inc. (VPI) and supported by a restricted educational grant from Abbott.

The patient was an 87-year-old man with leg pain at rest and gangrenous ulcers on his left foot. The patient has multiple health problems, including diabetes, and all of the arteries in his left calf were completely blocked. The procedure was successful in opening the most critical blockage below his knee and restored blood flow to his ailing foot. The patient was discharged home with no complaints of pain the morning after his procedure. He will now return at 1 month, 3 months, 6 months, and 12 months after his procedure for close monitoring of the stents used to open the blockage in his left calf.

"The Xpert stent is particularly appropriate for this trial because it is the only self-expanding stent that comes in a variety of sizes small enough to treat the blood vessels below the knee," said James Joye, D.O., national principal investigator for the XCELL trial. "The study is also important because it is one of only a very few independent, physician-sponsored efforts. VPI set the protocol, applied for the IDE and has contracted with a coordinating center, Prairie Education and Research Cooperative, to assist them with their data collection, evaluation and reporting."

It is estimated that 25 million people suffer from blockages in the arteries of the lower leg. Of those, up to 500,000 people suffer from unrelieved Critical Limb Ischemia (CLI), with approximately 80,000 amputations performed in the U.S. each year.

"Those with advanced disease may be poor candidates for surgery and have few treatment options, making many of them at high risk of losing a limb," Dr. Joye of El Camino Hospital in Mountain View, Calif., said. "We are very pleased to participate in this important study, and anticipate the results will help establish the standard for future clinical trial designs."

The El Camino Hospital is one of 10 centers participating in the XCELL study, which is expected to enroll 140 patients. The primary endpoint of the study is avoidance of major amputation at 12-months follow-up after treatment. Other centers participating in the study, and their principal investigators include:
-- UCLA Medical Center, Los Angeles; Thomas McNamara, M.D.
-- St. John's Hospital/Memorial Medical Center, Springfield, Ill.; Nilesh
Goswami, M.D.
-- Midwest Cardiovascular Research Foundation, Davenport, Iowa; Eric
Dippel, M.D.
-- Ochsner Clinic Foundation, New Orleans; John Reilly, M.D.
-- Washington University, St. Louis, Mo.; Patrick Geraghty, M.D.
-- Riverside Methodist Hospital, Columbus, Ohio; Charles Botti, M.D.
-- Charleston Area Medical Center, Charleston, W.Va.; Mark Bates, M.D.
-- University of Virginia, Charlottesville, Va.; John Angle, M.D.
-- Presbyterian Hospital of Dallas, Dallas; Tony Das, M.D.

About the Stent

The Xpert self-expanding nitinol stent is placed in the artery during a minimally invasive interventional procedure. In the technique, a catheter is inserted through a small nick in the skin and threaded through the blood vessels to the site of the blockage under X-ray guidance. The stent is deployed through the catheter and expanded to prop open the diseased artery. The stent is manufactured by Abbott and is cleared in the U.S. to treat blockages in the biliary ducts that carry digestive enzymes from the liver. It is the only self-expanding stent that comes in a variety of sizes small enough to treat the blood vessels below the knee.

About Peripheral Arterial Disease

Peripheral Arterial Disease (PAD) is a condition in which the arteries outside of the heart are narrowed or clogged by an accumulation of fat, cholesterol and other deposits that interfere with the normal flow of blood. Symptoms of PAD in the legs may include pain while walking, numbness and tingling, cold feet or legs, and ulcers or sores that do not heal. It is estimated that 25 million people suffer from blockages in the arteries of the lower leg.

About VPI

VIVA Physicians, Inc. (VPI) is a multi-disciplinary group of independent physicians who are nationally known experts in the diagnosis and management of all peripheral vascular diseases, and who joined together to advance education in vascular medicine and support research and innovative treatment options. In 2002, the group of 10 specialists in vascular medicine, vascular surgery, interventional cardiology and interventional radiology, organized VIVA: The National Education Course for Endovascular Interventions, an annual educational symposium held in Las Vegas that provides a highly interactive, "turf neutral" educational forum. The XCELL study is VPI's first clinical trial and meets the group's goal of sponsoring and executing trials that will support standards of practice. VPI also is involved in developing objective performance criteria for limb salvage and interventions for lower extremity peripheral arterial disease, and is investigating strategies to deal with in-stent restenosis and acute stroke intervention.

Source: VIVA Physicians

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