The New England Journal of Medicine
CO2 Laser Procedure Improves Patient Outcomes in Multi-Center Randomized Trial
FRANKLIN, Mass., Sept. 29 /PRNewswire/ -- PLC Systems Inc. (Amex: PLC),
today announced that researchers report in The New England Journal of Medicine
that patients with severe angina have significantly improved outcomes
following transmyocardial revascularization (TMR) with PLC's carbon dioxide
(CO2) heart laser. Study results demonstrated significantly reduced chest
pain, improved quality of life and increased blood flow to the heart following
the carbon dioxide laser treatment. PLC's CO2 heart laser is the only TMR
laser that has demonstrated increased blood flow to the heart.
"The study published in The New England Journal of Medicine reaffirms the
efforts we have put forth to become the leader in the TMR market," stated PLC
Systems' Chairman, President and CEO Ed Pendergast. "As the TMR marketplace
continues to build momentum, PLC is well positioned to provide this effective
procedure to the growing number of patients who suffer from severe angina."
Each year, approximately 80,000 Americans develop severe coronary artery
disease (CAD) that cannot be treated by conventional techniques, including
bypass surgery or angioplasty. Typically, they experience unrelenting angina
pain, despite being on maximum drug therapy, and are severely restricted in
their daily activities.
In the new study, a subset of patients in this population were randomly
assigned to undergo TMR using PLC's The Heart Laser SystemTM or receive only
cardiac medication therapy. Investigators compared both groups across a
spectrum of outcomes including severity of angina, quality of life and cardiac
blood flow. In the one-year, multi-center trial, they found:
-- A significant improvement in angina in the TMR patients:
72 percent as compared to 13 percent of those assigned to only
medication therapy.
-- Significantly improved quality of life for TMR patients as compared to
those receiving medication therapy.
-- A 20 percent improvement in blood flow to the heart in TMR patients.
Blood flow declined by 27 percent in the medication therapy.
-- Only two percent of patients assigned to the TMR group were
hospitalized for unstable angina in the first year of follow up, as
compared to 69 percent of those receiving medication therapy.
"Because severe CAD patients have run out of options, short of transplant,
the results from this study are encouraging," said O. Howard Frazier, M.D.,
the lead author and Chief of Cardiopulmonary Transplantation at the Texas
Heart Institute in Houston. "While not every CAD patient may be a candidate
for TMR or benefit from the procedure, the CO2 laser treatment does offer an
effective approach for treating patients with intractable heart disease."
"This index study also demonstrated significant improvement in overall
quality of life experienced by those patients who had the laser procedure,"
said Robert J. March, M.D., a principal investigator and a surgeon in the
Department of Cardiovascular-Thoracic Surgery at Rush-Presbyterian-St. Luke's
Medical Center in Chicago. "From decreased chest pain to being able to
comfortably climb a flight of stairs, those in the TMR group recorded a 38
percent improvement in their quality of life. Only six percent of the medical
treatment group improved."
"The one-year randomized comparison of TMR to maximum medication therapy
confirms the superiority of the laser procedure," said Keith A. Horvath, M.D.,
one of the principal investigators and an Assistant Professor of
Cardiothoracic Surgery at Northwestern Medical Center in Chicago.
Working with leading researchers and premier heart surgery centers around
the world, PLC Systems Inc. developed the world's first FDA-approved TMR
device, a high-powered laser known as The Heart Laser System. This computer
synchronized laser isdesigned to perform TMR in the safest manner possible.
The Heart Laser System was approved by the U.S. Food and Drug Administration
in August 1998 for treatment of the estimated 80,000 domestic patients each
year who suffer from severe coronary artery disease but cannot be treated with
conventional coronary revascularization techniques such as bypass surgery or
angioplasty.
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, 1998, and the Company's other SEC reports.
SOURCE PLC Systems Inc.
-0- 09/29/1999
/CONTACT: Investor Contact: John Jordan of PLC Systems Inc.,
508-541-8800, ext. 145; Media Contact: Kate Nixon of Wanger Associates,
617-965-6469/
/Web site: plcmed.com
(PLC)
CO: PLC Systems Inc.
ST: Massachusetts
IN: MTC
SU:
KO
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