Food And Drug Administration Notifies PLC Medical Systems Of Circulatory System
Devices Advisory Panel Meeting
FRANKLIN, Mass., May 19 /PRNewswire/ -- PLC Systems Inc., (AMEX:PLC) today announced that its wholly-owned subsidiary PLC
Medical Systems, Inc. has been informed by the Food and Drug Administration (FDA) reviewer of The Heart Laser(TM) TMR System that the
advisory panel meeting for circulatory system devices has been scheduled for July 28th and 29th. The meeting had previously been scheduled for
June. The FDA reviewer also informed the Company that TMR using The Heart Laser System is expected to be reviewed at the advisory panel
meeting.
Dr. Robert Rudko, Chairman of PLC Systems Inc., stated, ``We are very excited about presenting the clinical results of The Heart Laser TMR
System at the scheduled advisory panel meeting. Our clinical data continues to demonstrate statistical significance with respect to measurable
endpoints including angina (chest pain) relief and increases in myocardial perfusion (blood flow into the heart muscle).'' Dr. Rudko concluded,
``At this time, we will be contacting the clinical investigators of The Heart Laser TMR System and preparing for our presentation before the
panel.''
Official notification of the circulatory system devices advisory panel meeting will be posted in the Federal Register approximately 30 days prior to
the meeting. All FDA advisory panel schedules are subject to change.
PLC Systems Inc. is a cardiac revascularization company developing medical systems and technology with the potential to provide patients
suffering from coronary artery disease an alternative or adjunct to angioplasty and cardiac bypass surgery. PLC Medical Systems, Inc., a
wholly-owned subsidiary of PLC System Inc., has developed the high-powered CO2 Heart Laser system which uses the Company's patented
technology for a new cardiosurgical procedure known as Transmyocardial Revascularization (TMR). To date, more than 3,000 patients
worldwide have received treatment with The Heart Laser(TM) TMR system.
NOTE: Certain of the 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, no guarantee of FDA approval and other risk factors listed
from time to time in the Company's SEC reports.
SOURCE: PLC Systems, Inc. |
