ATS Medical gains CE approval for ATS 3f Enable aortic valve
17 December 2009
ATS Medical, Inc. (NASDAQ: ATSI) , has announced it has
received CE Mark approval to distribute its ATS 3f Enable Aortic
Bioprosthesis in the European Union.
ATS Medical says that the Enable valve is the first surgical aortic
valve replacement approved for commercial use that is implanted using a
sutureless technique. It is the first valve of the ATS 3f Enable
platform that combines the novel 3f tubular pericardial valve design
with its superior hemodynamic profiles and a self-expanding frame to
hold the valve in its optimal position.
The goal of the Enable valve is to achieve a less invasive aortic
valve replacement and reduce procedure times. Today, most aortic valve
surgery cannot be done on a minimally invasive basis because precise
suturing is difficult within the confined space of a minimally invasive
The sutureless Enable valve can be folded into a small diameter to
allow placement through a minimally invasive incision. Once the Enable
valve is delivered to the site of the annulus, it is expanded to its
preconfigured diameter and is held in place with a resistance fit.
"We have been implanting the ATS Enable valve for four years
achieving excellent hemodynamic and safety results. This valve is an
important step toward the goal of reducing procedure time and allowing
for a more minimally invasive approach to conventional valve surgery,"
stated Professor Jerzy Sadowski MD, PhD, Jagiellonian University,
Department of CV Surgery and Transplantology, Krakow, Poland. Professor
Sadowski and his surgical team performed the first human implant of the
Enable valve in January 2005.
"We are very excited to obtain the world's first approval for a
surgical sutureless heart valve. This initial offering in the Enable
platform is an important first step in bringing disruptive technology to
the traditional surgical market. Ultimately, we envision the Enable
platform facilitating minimally invasive procedures for patients with
conventional surgical indications," stated Michael Dale, President and
CEO of ATS Medical.
"Additionally, by reducing procedural time and the trauma
incurred with current conventional surgical procedures, we believe
Enable may also become a viable solution for certain patients who are
currently considered too sick for surgery."
Commercialization of the Enable valve will commence with a controlled
market release at select surgical centres in Europe. These sites will
serve as "Centres of Excellence" where surgeons throughout Europe will
be trained in the state-of-the-art techniques used for implanting the
Enable valve and will be instrumental in the development and launch of
future generations of the ATS 3f Enable platform. Release of the second
generation Enable is expected in the latter half of 2010.
The Company is continuing to develop sutureless tissue valve
technology for use in beating heart procedures based in part on the
characteristics of the next generation of Enable valves. First-in-man
studies of these novel technologies are targeted for 2010. It says that
commercialization of a beating heart solution could occur within one to
two years thereafter.