ATS Medical Announces FDA Clearance and First Implant of New ATS Simulus Semi-Rigid...

Mon Jul 6, 2009 6:30am EDT
 
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ATS Medical Announces FDA Clearance and First Implant of New ATS Simulus
Semi-Rigid Annuloplasty Band
Expands Heart Valve Repair Product Portfolio

MINNEAPOLIS, July 6 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq:
ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products
and services, today announced FDA clearance and the first implant of the ATS
Simulus(R) Semi-Rigid Annuloplasty Band. The Simulus Semi-Rigid Annuloplasty
Band was developed through the Company's collaboration with Genesee BioMedical
and represents the latest addition to the expanding portfolio of valve repair
products.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO)

Annuloplasty rings and bands are used in those cases where repair of a
patient's heart valve is preferable to replacement of the valve.  This new
repair product has clinical applications that expand the existing therapeutic
options for surgeons and their patients.  The Simulus Semi-Rigid Band is
specifically designed to respect the natural motion of the mitral annulus
during the cardiac cycle allowing for a more physiologic valve repair. This
unique characteristic can be particularly important in patients where both the
aortic and mitral valves are being treated.

Dr. Robert F. Hebeler, Jr., who performed the first implant of the ATS Simulus
Semi-Rigid Band at Heart Hospital Baylor in Plano, Texas commented, "This
Simulus Semi-Rigid Band represents the next advancement in annuloplasty repair
rings and provides an excellent option for my patients with mitral valve
regurgitation.  The band retains the natural saddle shape of the mitral valve
annulus and preserves mobility during the cardiac phases, particularly in the
aorto-mitral junction.  These design characteristics make the Simulus
Semi-Rigid Band easy to implant."

Michael Dale, President and CEO of ATS Medical added, "We are excited about
the growth and innovation we have brought to the annuloplasty repair market.
Our portfolio of Simulus annuloplasty products continues to be an important
contribution to our heart valve therapy product platform." 

About ATS Medical

ATS Medical, Inc. is dedicated to "Advancing The Standards" of cardiac surgery
through the development, manufacturing and marketing of innovative products
and services for the treatment of structural heart disease. ATS Medical serves
the cardiac surgery community by focusing on two distinct but operationally
synergistic market segments: heart valve disease therapy and surgical ablation
of cardiac arrhythmias.

ATS was originally founded to develop the ATS Open Pivot(R) Heart Valve as a
new mechanical heart valve standard of care. Today the Open Pivot heart valve
is the preferred mechanical heart valve in many markets around the world and
the fastest growing mechanical prosthesis in the market. Building on this
legacy and addressing the largest market segment in heart valve therapy, the
ATS 3f(R) brand encompasses an innovative tissue heart valve portfolio to
address conventional open surgery requirements as well as the growing demand
for less invasive sutureless based procedures. The ATS 3f(R) portfolio
includes offerings at various stages including early product development,
pivotal clinical trials, and market commercialization. Completing the
portfolio in heart valve therapy is the ATS Simulus(R) annuloplasty product
line. Simulus products assist the surgeon in repairing a patient's native
heart valve as an alternative to replacement. Continuing ATS Medical's focus
on serving the cardiac surgery community are the ATS CryoMaze(TM) products for
surgical cryoablation of cardiac arrhythmias. ATS CryoMaze(TM) products are
used by surgeons to treat patients suffering from cardiac arrhythmias, the
largest and fastest growing form of structural heart disease in populations
over 60 years of age. The ATS Medical web site is http://www.atsmedical.com.

Safe Harbor
This Press Release contains forward-looking statements that may include
statements regarding intent, belief or current expectations of the Company and
its management. Actual results could differ materially from those projected in
the forward-looking statements as a result of a number of important factors,
including the results of clinical trials, the timing of regulatory approvals,
the integration of 3f Therapeutics and the surgical cryoablation business of
CryoCath Technologies, Inc., regulatory actions, competition, pricing
pressures, supplier actions and management of growth. For a discussion of
these and other risks and uncertainties that could affect the Company's
activities and results, please refer to the Company's filings with the
Securities and Exchange Commission, including its Form 10-K for the year ended
December 31, 2008 and its most recent quarterly report on Form 10-Q.




SOURCE  ATS Medical, Inc.

Michael Dale, President/CEO, +1-763-553-7736, or Michael Kramer, CFO,
+1-763-557-2222, both of ATS Medical, Inc.; or Investors, Parice Halbert, CFA,
Westwicke Partners, LLC, +1-443-213-0500, for ATS Medical, Inc.

 

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