X-Message-Number: 18701

Subject: SF Gate: FDA panel backs first heart pump for long-term heart failure 
treatment
From: "Peter Christiansen" <>
Date: Mon, 4 Mar 2002 16:00 -0800

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This article was sent to you by someone who found it on SF Gate.
The original article can be found on SFGate.com here:


http://www.sfgate.com/cgi-bin/article.cgi?file=/news/archive/2002/03/04/national1845EST0789.DTL
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Monday, March 4, 2002 (AP)
FDA panel backs first heart pump for long-term heart failure treatment



   (03-04) 15:45 PST WASHINGTON (AP) --
   A heart pump long used to keep people alive as they awaited heart
transplants works well enough to be implanted permanently in certain
terminally ill patients too sick to get a new heart, government advisers
recommended Monday.
   Thoratec Inc.'s HeartMate is known as an assist device because it
temporarily boosts weakly beating hearts by taking over the work of the
organ's main pumping chamber, the left ventricle, until patients can get a
new heart implanted.
   Thousands of people with congestive heart failure are so sick that they
don't qualify to get one of the scarce hearts available for transplant.
Thoratec studied about 130 of these severely ill patients, implanted the
HeartMate into half of them and gave the rest standard drug treatment.
   The HeartMate cut deaths by 27 percent after the first year, prompting
Thoratec to seek Food and Drug Administration approval to market the
device as a permanent solution for these patients who otherwise would die
in months.
   FDA advisers recommended Monday that HeartMate get that new approval.
Because the device itself is risky, however, the panel put a list of
conditions on approval to ensure only the most optimal patient get a
permanent HeartMate -- and that he or she understands the device is not a
miracle artificial heart.
   HeartMate wasn't originally designed for long-term use and thus can break
down, a risk that increases over time, explained FDA heart device chief
Dr. Dan Schultz. The failure rate in the study was 20 to 30 percent, he
said.
   Side effects also included stroke, bleeding and infections, he said.
Infections are a particular problem, because with the HeartMate, a wire
leading through the skin connects the pump to a battery pack worn on a
shoulder strap.
   The FDA panel wants those risks as explicit as possible, through patient
warning brochures and additional data analyses, "to make sure that people
understand exactly what they're getting into," Schultz said.
   The FDA is not bound by its advisers' decisions but typically follows
them.

On the Net: HeartMate: www.thoratec.com/products/heartmate_lvas.htm

 
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Copyright 2002 AP

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