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Heartport recieved FDA approval today for its long awaited less invasive heart bypass procedure. I bought in at 35 1/8 with the stock already up 5 points. I will be looking for the stocj=k to hopefully reach new highs soon (over 43). This could be very soon with good media coverage.
Here is the press release:
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Oct. 7, 1996--Heartport,
Inc. (Nasdaq: HPRT), announced today that it received clearance from
the U.S. Food and Drug Administration (FDA) to market the Company's
Endovascular Cardiopulmonary Bypass (EndoCPB(TM)) System. The
EndoCPB System is a proprietary set of catheters, cannulae, and other
devices that permit a patient's heart to be stopped and protected,
and the patient to be safely maintained on cardiopulmonary bypass
during heart surgery, without the need to crack open the chest.
The Company also received pre-market notification exemptions from
the FDA, clearing its core reusable and disposable surgical devices
to be labeled and used for minimally invasive cardiovascular
surgery. These devices are integral to Heartport's Port-Access(TM)
CABG and Port-Access MVR Systems for heart surgery.
"We are very pleased that we have cleared these regulatory
hurdles," said Wesley D. Sterman, MD, Heartport's president and
chief executive officer. "The FDA action enables us to label and use
our systems explicitly for minimally invasive heart surgery, and
should allow us to launch our systems in the United States as much
as a year earlier than we previously expected."
Heartport also announced that, over the next month, it will begin
its clinical training program at leading U.S. medical centers,
including Barnes-Jewish Hospital at Washington University in St.
Louis, Brigham and Women's Hospital, The Cleveland Clinic Foundation,
Johns Hopkins, New York University, and Stanford University.
In preparation for its full-scale market launch, Heartport will
provide its core Port-Access CABG and Port-Access MVR Systems to the
medical centers leading its clinical training program. This will
enable these centers both to perform Port-Access heart surgery and
to train surgical teams from other leading medical centers. The
Company currently plans to make its complete Port-Access CABG and
Port-Access MVR Systems commercially available in the United States
by mid-1997, after it has scaled up its training and manufacturing,
and subject to receipt of FDA clearances for additional Port-Access
Heartport's Port-Access Systems are designed to allow surgeons to
perform a wide range of heart operations, including coronary artery
bypass grafting (CABG) and mitral valve replacement and repair (MVR),
through small incisions, or "ports," between the ribs, eliminating
the need to crack open the chest. The Company believes that its
systems may reduce the trauma, complications, and pain associated
with open-heart surgery, shorten hospital stays, reduce recovery
time, and lower overall costs.
Heartport, Inc., is a cardiovascular device company developing
minimally invasive Port-Access approaches to major heart surgery,
including coronary artery bypass grafting and heart valve replacement
Note: Except for the historical information contained herein,
this press release contains forward-looking statements, the accuracy
of which are necessarily subject to risks and uncertainties. Actual
events or results may differ materially due to factors set forth from
time to time in the Company's filings with the Securities and
Exchange Commission, including its prospectus dated April 25, 1996.
CONTACT: Heartport, Inc.
Jim Weiss, 415/482-4430
INDUSTRY KEYWORD: PHOTO PHOTOWIRE MEDICINE PRODUCT
REPEATS: New York 212-752-9600 or 800-221-2462; Boston 617-236-4266 or
800-225-2030; SF 415-986-4422 or 800-227-0845; LA 310-820-9473
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