SUNNYVALE, Calif., Aug. 1 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP), a leader in transmyocardial revascularization (TMR)
technology, announced today its patented Percutaneous Myocardial
Revascularization (PMR(TM)) System was used on a 'no-option' patient for the
first time in the U.S. at Stanford University Medical Center. No-option
patients experience debilitating chest pain (angina), resulting from severe
coronary artery disease, and are not candidates for conventional therapies.
CardioGenesis is the first company to initiate human clinical studies in the
U.S. using a minimally invasive approach for the treatment of no option
patients with this advanced proprietary percutaneous technology.
    "The start of the U.S. clinical trials for our PMR System represents the
launch of a major clinical program for CardioGenesis, and we believe this
furthers our leadership in the field of transmycardial revascularization,"
said Allen W. Hill, president and chief executive officer of CardioGenesis.
"The procedure, conducted by Dr. Stephen Oesterle, went as planned and the
patient is doing well. While it is too early to draw any conclusions regarding
the success of this first procedure, given the less invasive nature of our PMR
System, we believe this may represent a sizable market opportunity for
CardioGenesis," stated Hill.
    The 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. During the procedure
the patient remains conscious. There is no surgical incision. The beating
heart is accessed via a small puncture in the upper thigh through which a
CardioGenesis guiding and steering catheter system is placed into the femoral
artery, passed across the aortic valve, and positioned within the left
ventricle. Laser energy, synchronized to the patient ECG to minimize the risk
of irregular heart beats, is delivered through the fiber-optic equipped
catheter to create channels from the inside of the heart part way through the
diseased area of the left ventricle. The PMR System is engineered to provide a
high level of safety, control, stability, and freedom of movement in the left
ventricle for accomplishing the procedure. The objective of the PMR procedure
is to provide a therapy which significantly decreases chest pain and improves
the functional capacity for no-option patients, without the risk and costs
associated with a major surgical procedure.
    "Severe angina is a debilitating condition that diminishes the quality of
life for patients who have not responded to conventional therapies," said
Stephen N. Oesterle, M.D. Associate Professor of Medicine, Director Cardiac
Catheterization and Coronary Intervention Laboratories, who directed the team
of clinicians performing the first PMR procedure at Stanford. "The advent of
minimally invasive revascularization techniques such as PMR may offer clinical
benefits to this patient population who typically have no other alternative."
    The no option patient treated with the PMR System at Stanford is a
67-year-old male who takes multiple anti-anginal drugs and previously
underwent several prior interventions including a six vessel coronary artery
bypass grafting procedure, multiple percutaneous balloon angioplasty
procedures, and the placement of an intracoronary artery stent. The patient
experienced frequent bouts of debilitating chest pain even with little or no
physical exertion.
    Since November 1996, more than twenty no option angina patients have been
treated with CardioGenesis' PMR System in preliminary studies conducted in
Europe. Based on data obtained from pilot study, the total procedure time
required for the procedure has been approximately 50 minutes for experienced
interventional cardiologists. The time to create ten or more channels has been
approximately 15 minutes. In the most recent experience patients have required
only a brief hospitalization, typically two or three days.
    CardioGenesis Corp., based in Sunnyvale California, develops, manufactures
and markets proprietary systems including disposable products, to perform
intraoperative transmyocardial revascularization (ITMR(TM)), catheter-based
percutaneous myocardial revascularization (PMR(TM)), and thoracoscopic
transmyocardial revascularization (TTMR(TM)) to treat patients afflicted with
debilitating angina. These probes and catheter systems deliver laser energy to
create channels in the 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 for intraoperative myocardial device revascularization, U.S. Patent
5,380,316; and other patents in the field of transmyocardial
revascularization.
    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 reliance on Boston Scientific Corporation as
the exclusive distributor outside the U.S. for the company's products, effect
of possible pricing changes, the impact of indirect sales on operating
results, the timely availability and acceptance of new products, the impact of
competitive products and pricing, approval for and final results of clinical
studies, timing of regulatory approvals, potential third-party patent
infringement claims, the management of growth and the effectiveness of ITMR,
TTMR and PMR. 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 1996 Form 10-K as
filed with the Securities and Exchange Commission.

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