Steve,
Maybe we get approval in September???
FDA Advisory Panel Recommends Postponing Clearance For PLC Systems' Heart Laser TMR System
July 28, 1997 10:18 PM EDT
WASHINGTON, July 28 /PRNewswire/ -- PLC Systems Inc. (AMEX: PLC) today announced that an FDA Advisory Panel reviewed the data collected to date on The Heart Laser(TM) TMR System. At this point in the approval process, the Advisory Panel has recommended non-approval as well as the submission of additional data based on the existing study. After an in-depth discussion regarding approval requirements for this first-of-a-kind device, the Panel did not recommend a new study.
Dr. Robert Rudko, Chairman of PLC Systems Inc. stated, "The Panel has given us a better understanding of the data they desire and we will be working with the FDA over the weeks ahead to fulfill the data requests."
The Heart Laser TMR System remains on the expedited review path and will continue to be used by its clinical investigators.
"I believe all present at the Panel meeting recognized we were breaking new ground," said Dr. Rudko. "The Panel recommended that the company submit its 12-month follow-up and other data from the controlled randomized study of The Heart Laser TMR System." The last patients are due for their 12-month follow-up in early September.
TMR, or Transmyocardial Revascularization, uses The Heart Laser TMR System, a high-powered, computer synchronized carbon dioxide laser, to place channels into oxygen-deprived heart muscle of coronary artery disease patients. Although the exact mechanism of action is unknown, some researchers believe these channels then provide blood directly from the left ventricle to the deprived areas of the heart muscle, while others believe that angiogenesis also occurs. Recovery is generally quicker than that following bypass surgery. No blood transfusion is needed and, since the procedure is performed on a beating heart, there is no need for a heart-lung machine.
PLC Systems Inc. is a cardiac revascularization company developing medical systems and technology with the potential to provide patients suffering from coronary artery disease a third alternative or adjunct to angioplasty and cardiac bypass surgery. PLC Medical Systems, Inc., a wholly owned subsidiary of PLC Systems Inc., has developed The Heart Laser TMR System which uses PLC's patented 'heart-synchronized pulsed laser' technology for a new cardiosurgical procedure known as Transmyocardial Revascularization (TMR).
Note: Certain of the above statements may be forward-looking statements that involve risks and uncertainties. In such instances, actual results could differ materially as a result of a variety of factors, including competitive developments, regulatory approval requirements and risk factors listed from time to time in the Company's SEC reports. SOURCE PLC Systems Inc.
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