SUNNYVALE, Calif., Sept. 4 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP), a leader in transmyocardial revascularization (TMR)
technology, announced the preliminary results of a 21-patient feasibility
study conducted in Europe of its Percutaneous Myocardial Revascularization
(PMR(TM)) System. Preliminary results from six of these patients reporting at
three and six months demonstrated a drop in angina pain class, from an average
of 3.0 prior to therapy to an average of 1.5 at most recent visit. Angina pain
is classified on a four-point scale, with Class IV being the most severely
debilitating angina. An increase in exercise tolerance was also recorded for
patients after treatment with the CardioGenesis PMR System. The PMR System is
being studied by CardioGenesis for the possibility of its use in "no option"
patients with severe coronary artery disease who are not candidates for
conventional therapies, including coronary artery bypass graft surgery (CABG)
or percutaneous balloon angioplasty (PTCA).
    "We are pleased with these preliminary findings pertaining to our PMR
System," said Allen W. Hill, CardioGenesis' president and chief executive
officer. "The results provide the information and insights needed to move our
PMR clinical and regulatory programs forward. Reported reduction in angina
pain score and improvement in exercise tolerance are comparable to results we
have seen with studies using our Intraoperative Transmyocardial
Revascularization System (ITMR(TM)) and all patients in the feasibility study
of our PMR System so far are doing well," said Hill.
    The results of the feasibility study were presented last week at a
CardioGenesis-sponsored symposium during the Congress of the European Society
of Cardiology held in Stockholm, Sweden.
    CardioGenesis was the first company in the world to use a minimally
invasive percutaneous approach to TMR in "no option" patients. In July 1997,
CardioGenesis received approval from the FDA to start a multi-center clinical
trial of its proprietary PMR System to treat "no option" patients at up to
10 clinical sites in the United States. CardioGenesis treated its first
patient at Stanford University Medical Center on July 31, 1997 under the FDA
approved protocol.
    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 PMR System
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-proprietary 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's ECG to
minimize the risk of damage resulting from 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.
    CardioGenesis Corporation, 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 Number 5,380,316; and other patents in the field of
transmyocardial revascularization. For additional information on the company
and their products, visit the CardioGenesis website at http://www.cardiogenesis.com.
    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.
    For more information on CardioGenesis Corporation via fax, dial
800-PRO-INFO, code CGCP.

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