FDA Approves Device To Clear Blood Clots

[Guest guest]

FDA Approves Device To Clear Blood Clots

August 16, 2004

WASHINGTON (AP) -- The first device to

remove blood clots from the brains of people suffering strokes -- a new

treatment option that could save lives and shave the $53 billion annual

bill to treat strokes, has been approved by the government.

In 80 percent of strokes, a blood vessel

in the brain becomes clogged by a blood clot, increasing the chance of

severe disability or death.

The Merci Retriever, a tiny corkscrew

threaded through an artery to remove the clot and restore blood flow, is

produced by Mountain View, Calif.-based Concentric Medical.

The device, approved by the Food and

Drug Adminstration, was tested at 25 medical

centers around the nation in 141 patients ineligible for a drug that

clears clots but must be used within three hours of suffering a stroke.

Dr. Duckwiler,

a University of California-Los Angeles professor among the investigators involved in that

clinical trial, said 40 percent of patients whose blood clots were

successfully removed had positive outcomes.

Duckwiler said the recovery included instantly regaining the

ability to move or speak -- while the patient was still in the emergency

room.

" I've had patients who have had

dramatic recovery on the table, " he said. " Our neurologists

there, and in the study, were convinced this is going to save lives and

save brain function in many patients. "

Dr. Larry Goldstein, director of Duke University's Center for Cerebrovascular

Disease, called the approval " interesting " but added that it

remains unclear how many patients would benefit from the new treatment

option.

As part of the patient assessment, a

catheter must be inserted through the groin and snaked up the artery for

descriptive dye to outline blood vessels and point to obstruction,

Goldstein said. The task requires skilled medical workers.

" It's not the kind of thing that is

capable of being done in any hospital anywhere, " Goldstein said.

" The patient has to have a clot that is not only visible, but

accessible. That is a major, major limitation to begin with. "

Duckwiler agreed. But many patients don't qualify for the

current treatment -- a clot-busting drug -- because too many hours pass

before they recognize they've had a stroke. Some can't qualify because

they're taking drugs that impact blood clotting.

Duckwiler said the new device dramatically increases the

number of severe stroke sufferers who now can be treated.

The clinical trial results were

announced on Thursday night at the American Society of Interventional and

Therapeutic Neuroradiology's meeting in Boca Raton, Fla., said Duckwiler, the society's

president.

" It's been a hugely exciting event

for this society and its members who are anxious to have this tool to

treat stroke patients, " Duckwiler said.

According to the American Stroke

Association, strokes are the third-leading cause of death among

Americans. And stroke is the No. 1 ailment to nudge the elderly into

nursing homes. An estimated 700,000 people suffer strokes each year; some

163,538 died in 2001, the most recent annual data available.

Copyright 2004 The

Associated Press. All rights reserved.

Hugs,

Deanna

LUPUS Serenity

Prayer...

Lord, grant me the serenity to accept the things I cannot

change, the courage to change the things I can, and the wisdom to hide the

bodies of doctors I shot when they said, You're perfectly healthy, it's all in

your head "