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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