MINNEAPOLIS, April 20 /PRNewswire-FirstCall/ -- ATS Medical,
Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art
cardiac surgery products and services today announced the first
commercial implant of the ATS 3f® Aortic Bioprosthesis was recently
completed by Liu Zhi Gang, MD at Fu
Wai Hospital in Beijing, China.
Fu Wai Hospital is the largest cardiac surgery center in
Asia and a full line of ATS
products are utilized by their surgeons. ATS received
permission from the Chinese State Food and Drug Administration
(SFDA) to market the ATS 3f Aortic Bioprosthesis in March.
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As part of the launch effort in China, Mr. Kulvinder
Lall served as a proctor during the first case and
facilitated hands-on training for a number of other surgeons.
Mr. Lall is a Consultant Cardiothoracic Surgeon at the Royal
Hospital of St. Bartholomew in London,
England who has been implanting the ATS 3f Aortic
Bioprosthesis since 2006.
"The ATS 3f Aortic Bioprosthesis is much easier to implant than
other stentless valves. This is especially important in the
small sizes," stated Dr. Liu. A size 23 mm 3f Aortic
Bioprosthesis was implanted with a resulting mean pressure gradient
of 5 mmHg, which is considered an excellent hemodynamic performance
for the smaller size aortic annulus.
Based on the precept that 'Form Follows Function,' the ATS 3f
Aortic Bioprosthesis is a revolutionary next generation stentless
pericardial aortic tissue valve that is unlike any other valve.
It is 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 that it restores physiologic, non-turbulent blood
flow and native-like stress distribution to the aortic root.
This valve provides surgeons and patients a potentially more
durable solution to aortic valve replacement.
"The first ATS 3f Aortic Bioprosthesis implant at Fu Wai
Hospital was a great success. I believe that the ease of
implantation and excellent haemodynamics, especially in the small
aortas, makes this an ideal valve for the Chinese population,"
stated Mr. Lall.
"We are excited to expand our product portfolio in China to include the ATS 3f Aortic
Bioprosthesis. The tissue valve market in China nearly doubled in 2009 and is expected
to continue this rapid growth. China represents a significant
portion of ATS Medical's current revenue in 2009 and is one of the
most important growth markets in the world," stated Michael Dale, President and CEO of ATS
Medical.
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® Heart
Valve as a new mechanical heart valve standard of care. Today the
ATS 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®
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® 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® 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®
products for surgical cryoablation of cardiac arrhythmias. ATS
CryoMaze® 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.
Cautionary Statements
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 impact
of pending healthcare reforms, 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, 2009 and its most recent quarterly
report on Form 10-Q.
SOURCE ATS Medical, Inc.