SUNNYVALE, Calif., Feb. 4 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP) today reported the Health Care Finance Administration (HCFA)
has recommended issuance of an instruction providing for Medicare coverage of
Transmyocardial Revascularization (TMR). HCFA issued a Decision Memorandum
which specifies coverage of TMR "for patients with severe Class III or
Class IV angina (stable or unstable), which has been found refractory to
standard medical therapy." HCFA has not, at this time, specified a date when
coverage will become effective.
The policy decision provides hospitals, when the coverage decision becomes
effective, with the means to obtain reimbursement for Medicare patients
treated with Food and Drug Administration (FDA) approved TMR devices who
suffer severe angina and have limited or no treatment options. HCFA
previously established DRG 108 as the payment code for hospitals to use when
applying for Medicare coverage of TMR. Additional information on HCFA's
Decision Memorandum can be found on HCFA's website at
http://www.hcfa.gov/quality/8b3-d1.htm.
On October 22, 1998, CardioGenesis and Eclipse Surgical Technologies Inc.
(Nasdaq: ESTI) reported that they signed a definitive agreement in which the
two companies would combine in a reverse triangular merger. Under the terms
of the agreement, each share of CardioGenesis Common stock will be converted
into the right to receive 0.8 shares of Eclipse Common Stock.
CardioGenesis Corporation, based in Sunnyvale, Calif., develops,
manufactures and markets proprietary systems including disposable products, to
perform intraoperative transmyocardial revascularization (ITMR),
catheter-based percutaneous myocardial revascularization (PMR), and
thoracoscopic transmyocardial revascularization (TTMR), to treat patients
afflicted with debilitating angina. CardioGenesis catheter systems and probes
deliver laser energy to create channels in oxygen-deprived (ischemic) regions
of the heart muscle (myocardium). CardioGenesis holds patents for
percutaneous myocardial revascularization, U.S. Patent Number 5,389,096, and
for intraoperative transmyocardial revascularization, U.S. Patent Numbers
5,380,316 5,554,152, along with other patents in the field of transmyocardial
revascularization, and number of U.S. and international patent applications
pending. For more information on the company and its products, visit the
CardioGenesis website at http://www.cardiogenesis.com.
Please note: Except for the historical information contained herein, the
matters discussed in this release contain forward-looking statements that
involve risk and uncertainties, including: approval for and final results of
clinical studies; timing of regulatory approvals; reliance on Boston
Scientific Corporation as the exclusive distributor outside of the U.S. for
the company's products and pricing; potential third-party patent infringement
claims; the management of growth; and the effectiveness of the company's ITMR,
TTMR and PMR Systems, and of related procedures. For further information,
refer to risk factors under the caption "Management's Discussion and Analysis
of Financial Condition and Results of Operations - Risk Factors" and elsewhere
in the company's 1997 Form 10-K and the company's first quarter 1998 Form
10-Q as filed with the Securities and Exchange Commission.
SOURCE CardioGenesis Corporation
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Related links:
http://www.cardiogenesis.com
CONTACT:
Allen W. Hill, President and CEO, or Richard
P. Powers, Executive Vice President and CFO, 408-328-8500, both
of CardioGenesis Corporation; or General Information, Ann Trunko,
Analysts, Kate Rajeck, or Media, Scott Marx, 415-986-1591, all of
The Financial Relations Board
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