A SERVICE
OF 
Thoratec Plans to
Test Implantable VAD; Patient Discharged with Portable VAD Driver
PLEASANTON, Calif. · March 1, 2001· by TNN Medical
Reporter Virginia Baskerville
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Thoratec Corporation has issued two announcements concerning its
ventricular assist device technology.
- On February 21, Thoratec said it received conditional approval
from the Food and Drug Administration of an investigational device exemption
for its implantable ventricular assist device. The device is expected to be
tested in up to 30 patients at up to 10 centers. The IVAD is an implantable
version of Thoratec's paracorporeal VAD, which pumps blood to the body in heart
failure patients awaiting transplantation or recovery from open-heart surgery.
Thoratec said that, at less than a pound, the device is about half the size of
other commercially available implantable VADs.
"The IVAD utilizes the
same internal working components as the approved Thoratec VAD System blood pump
but has an outer housing made of a titanium alloy suitable for implantation. We
believe the approval pathway for this device will be via the abbreviated PMA
supplement process since the blood path for the IVAD is designed to be
essentially the same as the currently approved paracorporeal VAD," said D.
Keith Grossman, president and chief executive officer of Thoratec.
- On February 27, Thoratec said that a 46-year-old woman has
become the first U.S. patient to be discharged from the hospital supported by
Thoratec's TLC-II portable VAD driver, which powers the paracorporeal VAD. The
patient is a heart transplant candidate who has been supported by a Thoratec
VAD since September. Thoratec has conditional approval from the FDA to test the
VAD driver on a home-discharge basis. It has been approved for sale in Europe
for more than two years.
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