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ATS Medical Announces Initial Clinical Results Of Stand Alone Atrial Fibrillation Procedures Using ATS CryoMaze Product Line
ATS Medical, Inc.
(Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac
surgery products, announced initial clinical results of stand-alone
ablation procedures and an overall expansion into the stand-alone market,
using the ATS CryoMaze(TM) product line. This line of surgical products,
indicated for the treatment of cardiac arrhythmias, is designed to
replicate the original cut-and-sew Maze procedure (also known as
Cox-Maze-III) by freezing lines in the heart to re-direct electrical
impulses. The Maze procedure is a widely known surgical technique developed
by Dr. James L. Cox in the 1980s to treat atrial fibrillation (AF) with a
high rate of long-term success.
Current stand-alone ATS CryoMaze experience
In Ft Lauderdale on January 27, Dr. Evelio Rodriguez of East Carolina
University presented on six-month results of stand-alone AF ablations using
ATS Medical cryoablation products. In the presentation, Dr. Rodriguez
described the East Carolina University technique of performing a complete
stand-alone Maze procedure using cryoablation and robotic technique. This
technique is facilitated by the use of the da Vinci(R) Surgical System from
Intuitive Surgical, Inc., (Nasdaq: ISRG) to manipulate the cryoablation
probe inside of the heart. East Carolina University has treated 57 patients
with fully robotic stand-alone cryoablation. Prior to the procedure, 54 of
these patients had continuous Atrial Fibrillation, the most difficult type
of AF to ablate. At six-months of follow-up over 90% of the patients were
in sinus rhythm and only five of these patients were using antiarrhythmic
medication. Dr. Rodriguez said, "Stand-alone ablation using the ATS
cryoablation probes is a reliable method of replicating the complete Maze
procedure, with initial success rates that are similar to Dr. Cox's
original procedure, which was an extensive open chest surgical procedure."
East Carolina University is not alone in using ATS CryoMaze for
stand-alone AF ablation. More than 15 centers in the United States alone
have adopted ATS cryoablation products in stand-alone procedures. Like East
Carolina University, several hospitals are leveraging the da Vinci(R)
Surgical System as a part of the procedure while others are performing ATS
CryoMaze ablations by manipulating the cryogenic probe by hand.
The strengths of the stand-alone procedure using ATS CryoMaze are that
it can be done through a small incision, which is appealing to the patient,
and provides clinical results similar to the original cut-and-sew full Maze
procedure -- even in the patient populations that are historically the most
difficult to ablate, especially for cardiologists. The robust clinical
success of this procedure combined with the minimally invasive access site
is leading to a rapid adoption of this procedure for surgical stand-alone
procedures.
"Over the past several months ATS Medical has made significant progress
in advancing its therapies for the surgical treatment of cardiac
arrhythmias on a stand-alone or sole therapy basis," said Michael Dale, CEO
and President of ATS Medical. "Specifically, we have proven that our
current ATS CryoMaze products offer a successful, less invasive approach to
treating cardiac arrhythmias. We believe that further clinical results like
those reported by Dr. Rodriguez will position ATS as a leader in the
emerging field of minimally invasive cardiac arrhythmia treatment, which we
believe will be a multibillion dollar market opportunity by providing
curative solutions for the more than 50 million patients worldwide who
suffer from atrial fibrillation."
Development Update
As previously announced, the Company hired Dr. James Cox as Medical
Director, effective January 1, 2008. Dr. Cox is recognized and respected
worldwide for his many contributions to cardiac surgery. In particular, Dr.
Cox is recognized as the developer of the original surgical Maze procedure
which serves as the "gold standard" for the treatment of atrial
fibrillation. The Maze procedure is recognized to provide the highest
success rate of any surgical or cardiology treatment for atrial
fibrillation and is supported by longest-term clinical data extending more
than fifteen years. Dr. Cox in conjunction with the Company's research,
development, and marketing team are developing a series of products and
programs designed to make the ATS CryoMaze products the source for the
surgical treatment of atrial fibrillation through less-invasive approaches.
The team's focus is on developing tools and techniques to replicate the
gold standard Maze lesion set in both open chest and closed chest
procedures.
Concomitant Treatment -- The most common surgical ablation procedure
is the concomitant procedure in which an ablation is performed in
conjunction with other cardiac surgery, most typically a mitral valve
repair or replacement. The ATS development team is focused on providing
next generation tools to provide better ergonomics and access to the lesion
sites required by the Maze procedure. The Company anticipates introducing a
new ATS CryoMaze probe and clamp combinations during mid 2008.
Sole Therapy or Stand-Alone Treatment -- As described above, several
approaches have been used to perform ATS CryoMaze ablations on a less
invasive, closed chest basis. The Company's efforts under the guidance of
Dr. Cox will be focused on supporting the procedures and bringing new
products to market that enable these procedures in an easily reproducible
method with the gold-standard success rates of the original Cox Maze
procedure.
About ATS Medical
ATS Medical, Inc. provides innovative products and services focused on
cardiac surgery. The company, global in scope, is headquartered in
Minneapolis, Minnesota. More than 145,000 ATS Open Pivot(R) Heart Valves,
which utilize a unique pivot design resulting in exceptional performance
and low risk profile, have been implanted in patients worldwide. The ATS
3f(R) brand encompasses multiple tissue heart valve product offerings at
varying steps from market introductions to clinical trials to development
projects that incorporate less invasive valve replacement technology. ATS
Medical's focus on serving the cardiac surgery community is further
strengthened by offerings that include ATS Simulus(R) annuloplasty products
for heart valve repair, and ATS CryoMaze(TM) surgical ablation products.
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, 2006 and its most recent quarterly
report on Form 10-Q.
ATS Medical, Inc.
http://www.atsmedical.com
ATS medicale clinice, iniþial anunta rezultatele stand alone fibrilaþie atrialã, folosind procedurile de ATS CryoMaze linie de produse - ATS Medical Announces Initial Clinical Results Of Stand Alone Atrial Fibrillation Procedures Using ATS CryoMaze Product Line - articole medicale engleza - startsanatate