CUPERTINO, Calif., Aug. 2 /PRNewswire/ -- CardioThoracic Systems, Inc.,
(CTS), (Nasdaq: CTSI), a leader in minimally invasive cardiac surgery
technology, today announced it has received U.S. Food and Drug Administration
premarket clearance for the CTS(R) Voyager(TM) Aortic IntraClusion(TM) Device
for use in stopped heart procedures, including mitral valve replacement and
repair and coronary artery bypass graft surgery. This represents the
company's second product for stopped heart procedures; each year, over 700,000
such procedures are performed worldwide.
The CTS Voyager Aortic IntraClusion Device offers a less traumatic way of
eliminating blood flow to the heart -- a necessary step in any stopped heart
procedure. It is the first commercially-available cardiac surgery device with
an integrated design to perform four functions through a single incision,
including internal aortic occlusion, arterial perfusion, antegrade
cardioplegia delivery and aortic venting. Together, these features are
designed to reduce the trauma typically associated with multiple incisions and
external cross-clamping of the aorta -- a potential cause of stroke and
neurological deficits during stopped heart procedures.
"This latest product introduction is yet another example of CTS' diverse
position in the minimally invasive cardiac surgery market," explained Richard
Ferrari, CTS president and CEO. "Along with the CTS(R) Aurora(TM) MultiTrac
System, the company's access platform for less invasive valve surgery, CTS is
delivering procedure-enhancing technology we believe will improve the clinical
outcomes associated with traditional stopped heart surgery."
In mid-July, the first human cases using the CTS Voyager Aortic
IntraClusion Device were performed with very successful results. Dr. Ricardo
Lima, a surgeon from Real Hospital Portugues De Beneficencia in Brazil,
commented, "I am extremely excited about this product and I believe it is a
significant step towards minimizing the trauma of on-pump surgery."
Coupled with the 10 new products CTS launched earlier this year, the CTS
Voyager Aortic IntraClusion Device enables the company to sell at least one
product that can be used in virtually every adult cardiac surgery case. This
new device will begin shipping immediately to the first US clinical sites.
CardioThoracic Systems, Inc., located in Cupertino, Calif., is a leading
developer of proprietary technologies for use in minimally invasive cardiac
surgery. CTS introduced its first generation system for minimally invasive
beating heart bypass surgery in January 1997. Since that time, CTS has
shipped over 37,000 beating heart bypass systems.
The statements in this news release, including statements relating to the
company's product and development efforts and the capabilities and benefits of
the company's instrumentation and methods, contain forward-looking
information. Actual results may differ significantly from the results
discussed in the forward-looking statements as a result of risks and
uncertainties associated with the success of the company's development
efforts, the company's financial results, the acceptance of the company's
products and systems, the capabilities and benefits of the CTS instrumentation
and methods, the size of the market for the company's products, and the
coverage and benefits of the company's patents as well as other factors,
including factors set forth in the company's annual report on Form 10-K filed
with the SEC on March 30, 1999 and the company's most recent quarterly report
on Form 10-Q filed with the SEC on May 13, 1999. Copies of the Annual Report
on Form 10-K and the most recent quarterly report on form 10-Q are available
by calling the company's investor relations department at 408-342-1700.
To learn more about CardioThoracic Systems, Inc., visit the company's
website at http://www.cardioth.com .
For more information on CardioThoracic Systems, Inc., via fax at no cost,
dial 800-Pro-INFO or 908-544-2850 outside the U.S. Ticker symbol: CTSI.
SOURCE Cardio Thoracic Systems, Inc.
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Related links:
http://www.cardioth.com
CONTACT:
Steve Van Dick, CFO, 408-342-1700, or Media,
Ronda Prothro, pager, 800-704-0831, both of CardioThoracic
Systems, Inc.; or general information, Traci McCarty, analyst,
Janet Nelson, or media, C. Scott Marx, all of The Financial
Relations Board, 415-986-1591
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