SUNNYVALE, Calif., July 15 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP), a leader in transmyocardial revascularization (TMR)
technology, announced today it has received approval from the U.S. Food and
Drug Administration (FDA) to begin the multi-center clinical trial of its
proprietary Percutaneous Transmyocardial Revascularization (PMR(TM)) System to
treat angina in no-option patients at up to ten clinical sites.  No-option
patients experience debilitating chest pain (angina), resulting from severe
coronary artery disease, and are not candidates for conventional therapies.
    The proprietary CardioGenesis PMR System is designed to be used in a
minimally invasive procedure by an interventional cardiologist in a cardiac
catheterization laboratory in contrast to intraoperative TMR procedures
performed by surgeons in an operating room.  The patient remains conscious
during the procedure and the beating heart is accessed via a small puncture in
the upper thigh, through which a CardioGenesis PMR 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 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.
    "We are very pleased with the FDA's approval to start the U.S. clinical
trial of our PMR System," said Allen W. Hill, CardioGenesis' president and
chief executive officer.  "We believe the FDA approval of our request to move
to the multicenter trial furthers our leadership opportunity in the field of
TMR.  A pilot PMR study, conducted in Europe over the past six months,
provided the safety data and a regulatory pathway for us to take this course
with the clinical trial."  The Company originally expected to initiate patient
enrollment in the second quarter of 1997.
    No-option patients with Class III or Class IV angina are candidates for
the PMR trial.  The Company is authorized to conduct the trial at up to ten
cardiovascular treatment centers in the United States.  The sites have been
selected and training and orientation is underway.
    Since last November, when CardioGenesis first treated humans in Europe





with its PMR System, over twenty no-option patients have been treated.
"Although we have limited clinical results, we are pleased with the early
safety and efficacy performance, of the PMR System.  The data are tracking the
preliminary results seen in the ITMR pilot study and no deaths have been
reported," Hill said.  Total procedure time has been brief, averaging
approximately 50 minutes for experienced interventional cardiologists.  Time
to create ten or more channels averages less than 15 minutes.  The majority of
patients have been discharged from the hospital in two to three days.
Patients continue to be enrolled into the European pilot study.
    CardioGenesis Corporation, based in Sunnyvale, California, develops,
manufactures, and markets proprietary disposable products to perform
intraoperative transmyocardial revascularization (ITMR), catheter-based
percutancous myocardial revascularization (PMR), 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).
    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,
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.

Link to this page: