Medicare Panel Discusses Transmyocardial Revascularization Angina Relief Therapy
2004年7月15日 - 10:35PM
PRニュース・ワイアー (英語)
Medicare Panel Discusses Transmyocardial Revascularization Angina
Relief Therapy FRANKLIN, Mass., July 15 /PRNewswire-FirstCall/ --
PLC Systems (AMEX:PLC) reported that the Center for Medicare and
Medicaid Services (CMS) convened the Medicare Coverage Advisory
Committee (MCAC) yesterday to review and discuss the evidence and
clinical data regarding transmyocardial revascularization (TMR) as
it relates to Medicare patients with severe angina. The MCAC is an
advisory panel consisting of clinicians and other medical experts
which is used to supplement CMS's internal expertise. During the
meeting, surgeons representing the Society of Thoracic Surgeons
(STS) discussed with the MCAC panel the clinical data, evidence,
and personal experiences that support the use of the TMR therapy.
"TMR has always enjoyed an active dialogue in the medical
community, which fostered the lively discussions at today's
meeting," said Mark R. Tauscher, president and CEO of PLC Systems.
"We believe that the MCAC process provided valuable information to
the Panel, to industry participants and to clinicians. We look
forward to working with the medical community in this process to
continue to add to the clinical body of evidence that supports the
use of TMR for patients suffering from severe angina." Since FDA
approval in 1998 and CMS's reimbursement coverage decision in 1999,
several well-qualified technical assessment bodies and physician
specialty societies have analyzed available TMR data. These
organizations have concluded that the evidence favorably supports
TMR for certain patients, and/or that TMR provides significant
angina relief in certain patients. These assessments or practice
guidelines include: -- Society of Thoracic Surgeons (STS) Workforce
on Evidence-Based Surgery 2004; -- American College of
Cardiology/American Heart Association (ACC/AHA) Task Force on
Practice Guidelines 2002 (published 2003); -- Blue Cross and Blue
Shield Association (BCBSA) Technology Evaluation Center Assessment
on TMR as an Adjunct to CABG Surgery for the Treatment of Coronary
Artery Disease 2001, reviewed in 2004; -- The Agency for Healthcare
Research and Quality (AHRQ) Technology Assessment of Percutaneous
Myocardial Laser Revascularization and Transmyocardial Laser
Revascularization 2004; -- ECRI Technology Assessment Report on
Transmyocardial Laser Revascularization (TMR)/ Percutaneous
Myocardial Laser Revascularization (PMR) for Treatment of
Refractory Angina 2004. PLC Systems is a medical technology company
specializing in innovative technologies for the cardiac and
vascular markets. Currently, the company is focused on two unique
laser therapies for the treatments of severe angina and cardiac
arrhythmias. Headquartered in Franklin, Mass., PLC pioneered the
CO2 Heart Laser System that cardiac surgeons use to perform CO2
transmyocardial revascularization (TMR) to alleviate symptoms of
severe angina. For the cardiac arrhythmia market, PLC is developing
a surgical cardiac ablation laser technology, known as the
Optimaze. Additional company information can be found at
http://www.plcmed.com/. This press release contains
"forward-looking" statements. For this purpose, any statements
contained in this press release that relate to prospective events
or developments are deemed to be forward-looking statements. Words
such as "believes," "anticipates," "plans," "expects," "will" and
similar expressions are intended to identify forward-looking
statements. Our statements of our objectives are also
forward-looking statements. While we may elect to update
forward-looking statements in the future, we specifically disclaim
any obligation to do so, even if our estimates change, and you
should not rely on these forward-looking statements as representing
our views as of any date subsequent to the date of this press
release. Actual results could differ materially from those
indicated by such forward-looking statements as a result of a
variety of important factors, including we may be unable to
successfully develop products under our agreement with Edwards
Lifesciences and Edwards may be unsuccessful in distributing these
products, operational changes, competitive developments may affect
the market for our products, regulatory approval requirements may
affect the market for our products, we may be unable to convince
health care professionals and third party payers of the medical and
economic benefits of the CO2 Heart Lasers and the Optimaze System,
and there can be no assurance that all payers will reimburse health
care providers who perform TMR procedures or that reimbursement, if
provided, will be adequate, and additional risk factors described
in our Report on Form 10-K for the year ended December 31, 2003,
and our other SEC reports. PLC Systems, PLC Medical Systems, PLC
and CO2 Heart Laser are trademarks of PLC Systems Inc. Contact:
John Jordan Director of Investor Relations 508-541-8800, ext. 145
DATASOURCE: PLC Systems CONTACT: John Jordan, Director of Investor
Relations of PLC Systems, +1- 508-541-8800, ext. 145 Web site:
http://www.plcmed.com/
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