Thoratec Laboratories has received Food and Drug Administration approval for an investigational device exemption (IDE) for its TLC-II Portable Ventricular Assist Device (VAD) Driver.
The company plans to begin enrollment for a clinical trial of the device at eight cardiac surgery centers by the end of the year. The trial, which will include up to 20 patients now using Thoratec's VAD System circulatory support device, is expected to be completed by mid 1999. The TLC-II powers Thoratec's VAD blood pumps and can be used interchangeably with the VAD System Dual Drive Console.
"The experience of these patients on the TLC-II will be compared with that while on the Dual Driver. We will be monitoring safety and effectiveness endpoints while in the hospital and during excursions away from the hospital," Thoratec said.
"We are hopeful this will lead to commercial release of the device in 1999," said D. Keith Grossman, Thoratec's president and chief executive officer. The TLC-II is available in Europe and was recently approved for use in Canada (see Transplant News Network, October 1, 1998). While using the TLC-II, some patients have returned home from the hospital while waiting for a transplant.
Thoratec said that the VAD System has been used successfully in more than 1000 patients, representing more than 37,500 VAD pump days of total usage. The youngest patient to have used the device is a seven-year-old, 38-pound boy who spent 22 days on the VAD System while awaiting a transplant.
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