PRESS RELEASE:PLC Systems Gets CE Mark OK For Laser Sys
08 Mar 09:45
PLC Systems Receives CE Mark Approval to Market Next-Generation CO2 Heart
Laser 2(TM) System Throughout the European Union
FRANKLIN, Mass., March 8 /PRNewswire/ -- PLC Systems Inc. (AMEX: PLC), the
leader in carbon dioxide (CO2) transmyocardial revascularization (TMR), today
announced that the Company received CE Mark approval for its next-generation
CO2 Heart Laser 2. The CE Mark allows PLC to begin marketing the smaller, more
mobile TMR laser throughout the European Union and other countries that base
regulatory clearance on the European CE Mark. In January of this year, PLC
announced that the Company received U.S. Food and Drug Administration (FDA)
approval to market the next-generation CO2 Heart Laser 2 system.
(Photo: newscom.com )
Building on the strong clinical performance of PLC's first-generation TMR
laser, the next-generation CO2 TMR heart laser has greater mobility due to its
significantly smaller size. PLC's first- and next-generation TMR heart lasers
provide equivalent clinical outcomes. To address the worldwide TMR
opportunity, PLC is introducing a stratified pricing structure and will
continue to market and sell its first-generation heart laser.
"The international TMR market is a great opportunity and we are excited to
introduce our next-generation CO2 Heart Laser 2 to cardiac surgeons on a
worldwide basis," said PLC Systems' President and CEO Mark R. Tauscher. "We
believe the potential for the international TMR market is approximately 35,000
to 70,000 patients per year, which is based on an adoption rate of 10 to 20
percent of the total number of coronary artery bypasses performed each year. As
a result of the CO2 Heart Laser 2 introduction, PLC pricing structure addresses
the needs of different market segments and economic models. The
first-generation heart laser will now be marketed to small volume or capital
constrained heart center accounts that could not previously afford a heart
laser."
The CO2 TMR therapy is a surgical procedure that improves blood flow to the
myocardium of the left ventricle of the heart, which relieves chest pain in
severely debilitated heart patients. A cardiac surgeon utilizes the laser to
create approximately 20 to 40 channels to allow oxygen-rich blood to reach
previously deprived areas of the patient's heart. More than 7,000 patients
have been treated with a CO2 heart laser.
The CO2 heart laser is the only TMR laser that has reported and published
long-term angina relief results. On November 15, 2000, Dr. Keith Horvath of
Northwestern University Medical Center presented results from the first multi-
center, long-term study on the efficacy of TMR using a CO2 heart laser. This
data demonstrated that the CO2 TMR procedure provided patients angina relief
for five years. Dr. Horvath provided the long-term data at the American Heart
Association's Scientific Sessions 2000.
PLC is the leader in the development of products for performing a surgical
laser procedure known as CO2 TMR. TMR offers a treatment option for patients
who suffer from severe coronary artery disease. Coronary artery disease, the
leading cause of death in the United States and Europe, is expected to increase
as the worldwide population continues to age.
Working with leading researchers and premier heart surgery centers around the
world, PLC developed the world's first FDA-approved TMR device, a high- powered
laser known as the Heart Laser System. Designed to perform TMR in the safest
manner possible, the CO2 Heart Laser 2 was approved by the U.S. Food and Drug
Administration for the treatment of areas of the heart not amenable to direct
revascularization, which is the same indication for use as PLC's first
generation heart laser.
For more information on PLC and its products, please visit the Company's Web
site at www.plcmed.com.
Note: Certain of the above statements are forward-looking statements that
involve risks and uncertainties. Actual results could differ materially from
those indicated by such forward-looking statements as a result of a variety of
factors, including operational changes, competitive developments, regulatory
approval requirements, the ability to convince health care professionals and
third party payers of the medical and economic benefits of The Heart Laser
System, no assurance that all payers will reimburse health care providers who
perform TMR procedures or that reimbursement, if provided, will be adequate,
and risk factors described in the Company's annual report, SEC form 10-K for
fiscal year ended December 31, 1999, and the Company's other SEC reports.
SOURCE PLC Systems Inc.
/CONTACT: John Jordan, Director of Investor Relations of PLC Systems Inc.,
508-541-8800, ext. 145/
/Photo: NewsCom: newscom.com
AP Archive: photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 201-369-3467/
/Web site: plcmed.com
(PLC) CO: PLC Systems Inc. ST: Massachusetts IN: MTC SU: PDT
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