Over 290 "No Option" Patients Included in the Study
SUNNYVALE, Calif., July 7 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP), a leader in percutaneous and intraoperative transmyocardial
revascularization (TMR) technology, announced today that it has completed the
enrollment and treatment of patients in its pivotal prospective randomized
Phase II trial of its Axcis(TM) Percutaneous Myocardial Revascularization
(PMR) System. All "no option" patients had severe coronary artery disease and
Class III or Class IV angina, were untreatable with bypass surgery or balloon
angioplasty and were taking the maximum recommended levels of anti-anginal
drugs.
The trial, which includes over 290 patients, is being conducted at 12
major cardiovascular treatment centers located in both the United States and
Europe, including Stanford University Medical Center, Johns Hopkins University
Medical Center, Baylor College of Medicine, the Mayo Clinic, and Papworth
Hospital, Cambridge, United Kingdom. CardioGenesis is currently conducting
three, six and twelve month patient follow-ups with the primary study outcome
measures being reduction in angina class and improvement in exercise
tolerance.
"The completion of the enrollment in the U.S. pivotal prospective
randomized trial of the CardioGenesis Axcis PMR System represents the
achievement of a significant milestone for our company," said Allen W. Hill,
President and Chief Executive Officer of CardioGenesis. "To be the first
company to complete enrollment in a Phase II trial in PMR gives CardioGenesis
a significant lead over the competition. We believe the prospects are good
that the over 70 percent of TMR patients will ultimately be treated with the
percutaneous approach," said Hill.
Regulatory Status
CardioGenesis expects to initiate preliminary discussions with the Federal
Food and Drug Administration (FDA) regarding filing for regulatory approval
and intends to submit information and updates for the formal follow up period
of the study. This proactive and collaborative approach to submissions is
intended to provide CardioGenesis a means for frequent reviews by the FDA of
information required for Pre-Market Release Approval (PMA) of the Axcis PMR
System.
PMR Clinical Results
Clinical data from a pilot clinical study in Europe presented at the
recent American College of Cardiology (ACC) Annual Conference in Atlanta, Ga.,
reported that patients treated with the Axcis PMR System experienced a
50 percent reduction in mean angina class and a significant improvement in
exercise tolerance. These results are comparable to those achieved in "no
option" patients treated with intraoperative TMR. CardioGenesis was the first
company ever to initiate clinical studies of a minimally invasive percutaneous
approach to TMR in Europe in November 1996, and treated the first PMR patient
ever in the U.S. in July 1997.
The Axcis PMR System is designed to be used by an interventional
cardiologist in a cardiac catheterization laboratory, in contrast to
intraoperative TMR procedures performed by surgeons in an operating room. The
objective of the Axcis PMR System is to provide a less invasive treatment
option which also decreases chest pain and improves exercise tolerance of "no
option" patients. During the PMR procedure, the patient is sedated and
remains conscious. The beating heart is accessed via a femoral artery through
a small puncture in the upper thigh. A CardioGenesis aligning and laser
catheter system is placed into a femoral artery, passed across the aortic
valve, and positioned within the left ventricle. Fifteen to twenty channels
are typically created inside the left ventricle with the procedure being
conducted in a conventionally equipped cardiovascular laboratory using
single-plane or bi-plane fluoroscopy equipment. PMR procedures are often
conducted in one hour or less and patients are typically discharged within
days following the procedure.
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 the system
and method of percutaneous myocardial revascularization, U.S. Patent Number
5,389,096, the method of intraoperative myocardial device revascularization,
U.S. Patent Number 5,380,316; and other patents in the field of
transmyocardial revascularization. For more information on the company and
its products, visit the CardioGenesis web site at http://www.cardiogenesis.com.
Please note: Except for the historical information contained herein, the
matters discussed in this news release are 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, as well as 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 as filed with the Securities and Exchange
Commission.
SOURCE CardioGenesis Corporation
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Related links:
http://www.cardiogenesis.com
CONTACT:
Allen Hill, President and CEO, or Richard
Powers, Vice President and CFO, 408-328-8500, both of
CardioGenesis Corporation; or Ann Trunko, general information, or
Kate Rajeck, analyst contact, 415-986-1591, both of The Financial
Relations Board
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