First Registry on Minimally Invasive Bypass Contains Data on Over
1,100 Patients
CUPERTINO, Calif., Nov. 12 /PRNewswire/ -- The CardioThoracic Systems,
Inc. (CTS) (Nasdaq: CTSI) MIDCAB(TM) (Minimally Invasive Direct Coronary
Artery Bypass) Registry was presented by Richard Holubkov, Ph.D. of the
University of Pittsburgh today at the 70th Scientific Session of the American
Heart Association (AHA). The CTS MIDCAB Registry contains data on more than
1,100 patients and is the first worldwide, multi-center prospective
observational study of MIDCAB results published in peer reviewed academic
journals.
The CTS MIDCAB Registry is a compilation of data from a total of
1,148 patients analyzed from April 1996 through October 1997. These MIDCAB
procedures were performed by 84 surgeons at 57 centers throughout the world
utilizing the CTS Access Platform and Stabilizer and the CTS LIMA-Lift(TM).
The CTS MIDCAB Registry data include vital statistics supporting the use
of CTS instrumentation in minimally invasive beating heart bypass procedures.
The Registry data show a median operating time of approximately two hours
(continually decreasing as the surgeon obtains more experience), a median
intensive care unit (ICU) stay of less than 24 hours and a median
post-operative hospitalization stay of four days. Conversion to
cardiopulmonary bypass was not required in 97.5 percent of the patients and
93.5 percent were discharged without myocardial infarction (MI) or
reintervention. Additionally, a patency rate of 96 percent was demonstrated
at centers contributing consecutive, controlled angiographic follow-up.
"We believe the data from the CTS MIDCAB Registry establishes the safety
and efficacy of the MIDCAB procedure in the patient population treated. There
was a low rate of both mortality and conversion to the cardiopulmonary bypass
(CPB) machine, demonstrating the success of this minimally invasive surgical
technique," said Rich Ferrari, CTS President and CEO. "This patient registry
provides a global assessment of the MIDCAB procedure as well as a strong
foundation for more rigorous studies evaluating the MIDCAB procedure compared
to other revascularization techniques."
In addition to sponsoring the CTS MIDCAB Registry, CTS is also currently
sponsoring the POEM(TM) (Patency Outcomes and Economics of MIDCAB) Study. The
POEM Study is designed to provide an angiography-based assessment of follow-up
anastomosis patency in CTS MIDCAB patients compared to the patency rate in
standard coronary artery bypass graft (CABG) procedures.
For more information on either the CTS Registry or POEM Study, contact
Christine Carbone, Director of Marketing Communications, at 408-342-1700.
CardioThoracic Systems, Inc., Cupertino, Calif., is a leading developer of
proprietary technologies in minimally invasive cardiothoracic surgery. The
company's current products are designed to enable cardiothoracic surgeons to
perform minimally invasive bypass surgery on a beating heart. CTS is also
developing technologies in the areas of minimally invasive valve repair and
replacement and saphenous vein harvesting. The company's stock is traded on
the Nasdaq Stock Market under the symbol CTSI.
This news release contains forward-looking information that involves risks
and uncertainties, including, risks relating to the acceptance of the MIDCAB
procedure, and the result of the MIDCAB procedures, the market acceptance of
the Company's products, competitive technology and revascularization
techniques, and uncertainties associated with the CTS MIDCAB Registry, the
results and effects of the POEM Study and the reliance on favorable clinical
data. Actual results may differ significantly from the results discussed in
the forward-looking statements as a result of those and other factors,
including factors set forth in the company's annual report on Form 10-K filed
with the Securities and Exchange Commission on March 31, 1997 and the
company's quarterly report on Form 10-Q filed with the Securities and Exchange
Commission on November 7, 1997. Copies of the Annual Report on Form 10-K are
available by calling the company's investor relations department at
408-342-1700.
For more information on CardioThoracic Systems, Inc. via fax at no cost,
dial 800-PRO-INFO (908-544-2850 outside the U.S.), ticker symbol: CTSI.
SOURCE CardioThoracic Systems, Inc.
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CONTACT: media, Christine Carbone, Director of Marketing Communications of CardioThoracic Systems, Inc., 408-342-1700; or investors, general information, Ann Trunko, or analysts, Kate Rajeck, of The Financial Relations Board, 415-986-1591, for CardioThoracic Systems, Inc.; or Steve Van Dick, CFO of CardioThoracic Systems, Inc., 408-342-1700
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