ATS Medical Inc.
(Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac
surgery products and services, announced that a total of 47 patients
have now undergone aortic valve replacement with its sutureless ATS 3f
Enable(TM) Aortic Bioprosthesis at seven investigative sites in Europe
within both the feasibility and pivotal clinical trial phases. Currently,
eight patients have surpassed the two year implant duration.
The ATS 3f Enable Aortic Bioprosthesis is designed to eliminate the
traditional suturing required to replace a patient's diseased aortic heart
valve. If suturing can be eliminated from the procedure, surgeons can
potentially reduce procedure time and offer less invasive options for the
treatment of aortic valve disease. In addition, the elimination of suturing
offers the potential to significantly improve valve related hemodynamics by
allowing the surgeon to provide a replacement valve of a size larger than
what is traditionally possible with conventionally sutured heart valves.
The most recent phase of the clinical trial was designed to evaluate
the effectiveness of the ATS 3f Enable Aortic Bioprostheses "sutureless"
solution with respect to hemodynamics, avoiding peri-valvular leakage, and
valve migration post surgery. After more than 25 consecutive procedures
within the pivotal trial phase utilizing an updated pivotal trial protocol,
the ENABLE 'sutureless' solution has provided excellent clinical outcomes
for peri-valvular leak comparable to conventional surgery. It has been
further established that valve migration has not been a risk with the
ENABLE heart valve.
Prof. Thierry P. Carrel of the University Hospital of Bern, Switzerland
stated, "We are very encouraged by our ATS 3f Enable heart valve
experience. The unique sutureless implantation feature of the ENABLE valve
provides several important clinical benefits for our patients. Notably,
because the valve requires no sutures to implant we are able to put in a
larger valve than would otherwise be possible using a conventionally
sutured heart valve. As a result, the hemodynamic performance observed is
truly outstanding. And unlike with sutureless percutaneous valves, there
has been no trade off or compromise in clinical performance. Specifically,
we have not observed any peri-valvular leaks or migration with the ENABLE
prosthesis. Prof. Friedrich S. Eckstein, also of the University Hospital of
Bern, added, "The ENABLE sutureless implant procedure is remarkably simple.
Because we are able to eliminate the suturing and much of the time that
normally accompanies aortic valve replacement, we have been able to provide
more of our patients a less invasive procedure using smaller incisions
without compromising clinical outcome."
ATS Medical Inc. President and CEO, Michael Dale said, "We are very
pleased with the results from our updated pivotal protocol. The potential
benefits of a sutureless aortic heart valve are many, but up until the
introduction of the ENABLE heart valve, 'sutureless' designs could not
claim equality with conventional surgery outcomes. This was particularly
true with regard to peri-valvular leakage. For less invasive aortic valve
surgery to move forward as a standard of care, clinical outcomes must be at
least equivalent to conventional surgical technique. We believe these
results for ENABLE demonstrate this is possible. Our intellectual property
in this area is comprehensive and we believe our design is practical and
with this milestone we look forward to expanding our enrollment in this
exciting clinical trial."
Prof. Sven Martens, MD, PhD, of Johann Wolfgang Goethe University
Hospital in Frankfurt, Germany said, "The ATS 3f Enable Aortic
Bioprosthesis has been chosen by us because of the excellent hemodynamics,
especially in patients with a small aortic annulus. The early results are
very promising and while more time is needed, we believe that for these
patients, this device may truly advance the standard of care for aortic
valve surgery."
The ATS 3f Enable Aortic Bioprosthesis is the second product stemming
from the ATS 3f(R) Aortic Bioprosthesis platform. Utilizing the same valve
leaflet design and materials, the company has been able to preserve
excellent product performance and durability. ATS has now expanded into the
sutureless implant procedure and will utilize these base products and
technologies to further advance the standard of heart valve repair and
replacement. ATS' strategy has been to develop and provide an excellent
Aortic Bioprosthesis, to utilize this platform to improve standard aortic
valve replacement surgery through sutureless products and procedures, and
then to provide products and procedures to allow for minimally invasive
heart valve repair and replacement in a safe and effective manner. The
company will proceed with an expanded clinical evaluation at a select
number of international sites as we proceed through the regulatory process
for US IDE and International CE Mark approvals.
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 140,000 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, ATS CryoMaze(TM) surgical ablation products, and
RTI-Cardiovascular for allograft tissue services. The ATS Medical web site
is atsmedical.
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.
atsmedical
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