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FDA Approves New Device to Unblock Heart Arteries

Washington, D.C., August 3, 1994 -- FDA today announced the approval of a medical device to unblock and keep open obstructed heart arteries. It has been shown to be superior in some respects to balloon angioplasty.

When used in clinical trials, the device, the Johnson & Johnson Palmaz-Schatz Balloon-Expandable Stent, outperformed balloon angioplasty by achieving greater enlargement of arteries and reducing the rate of repeat blockage by 25-35 percent over the next six months. However, patients were more likely to experience bleeding and clotting complications and required longer hospital stays.

"This device is an important treatment for certain patients with heart disease," said FDA Commissioner David A. Kessler, M.D. "For these patients, it will work better than balloon angioplasty."

In balloon angioplasty, a catheter incorporating a strong plastic balloon is inserted into an artery in the arm or leg and threaded to the blockage in the coronary artery. It is then inflated, compressing the plaque into the artery wall and opening the artery. The balloon catheter is then removed.

The stent is a stainless steel device that is permanently placed into the coronary artery by a catheter, similar to a balloon angioplasty catheter. Shaped like a small slotted tube, the stent acts as a "scaffolding device" that serves to enlarge and keep open the artery at the point of obstruction. The procedure significantly improves the flow of blood to the heart muscle.

The stent is designed for use in patients with atherosclerosis who have a short blockage in a large artery. Atherosclerosis is a progressive heart disease in which the heart arteries become blocked with fatty plaque, causing chest pain and heart attacks.

FDA's decision to approve the product was based on a review of safety and effectiveness data from clinical studies of some 2,000 men and women patients at 48 medical centers in North America and Europe, and on the recommendation of the Circulatory System Devices Panel of the agency's Medical Devices Advisory Committee.

FDA is one of eight Public Health Service agencies in HHS.

Source: U.S. Food and Drug Administration, Sharon Snider (301) 443-3285

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