ATS Medical Announces FDA Approval for a Landmark Clinical Investigation of the ATS...

ATS Medical Announces FDA Approval for a Landmark Clinical Investigation of
the ATS 3f Aortic Bioprosthesis

MINNEAPOLIS, Aug. 27 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq:
ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products
and services, announced today that the FDA has approved a landmark clinical
study in which cardiac surgeons will implant the ATS 3f(R) Aortic
Bioprosthesis in a younger aortic valve replacement patient population that
has not been previously studied in a controlled and scientific manner.

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

This new FDA approved clinical study will enroll patients younger than 60
years of age, with half of the population younger than 50 years of age. The
Company believes that this study will ultimately demonstrate the excellent
safety, efficacy and durability of the ATS 3f Aortic Bioprosthesis in this new
patient population, while illustrating the performance necessary to maintain
the active lifestyle of the younger population.

The ATS 3f Aortic Bioprosthesis is an aortic valve designed to function just
like a native valve. Its tubular design was inspired by how a native valve
forms in utero: as a tube with sides that collapse when external pressure is
applied. The primary benefit of the ATS 3f Aortic Bioprosthesis is its
tubular design and that it restores physiologic non turbulent blood flow and
native-like stress distribution to the aortic root. This valve design
provides surgeons and patients with a potentially more durable solution to
aortic valve replacement.

ATS Medical is working diligently on hospital selection and patient enrollment
will commence immediately after Institutional Review Board approval has been
granted at each site. "We are encouraged by the FDA approval to pursue this
landmark opportunity in an approved post-market study with the ATS 3f Aortic
Bioprosthesis in a younger patient population. We look forward to the
outcomes that will demonstrate scientifically that the ATS 3f Aortic
Bioprothesis is the highest performing tissue valve available to all patients
in need of aortic valve replacement," said Astrid Berthe, Vice President of
Regulatory Affairs.

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,
of Westwicke Partners, LLC, +1-443-213-0500, for ATS Medical, Inc.