Aortic Bioprosthesis in the European Union, indicating it is
compliant with relevant European health, safety, and environmental protection legislation. 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 which combines the novel 3f tubular pericardial
valve design with its superior hemodynamic profiles and a self-expanding frame to hold the valve in its
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 procedure. 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
centers in Europe. These sites will serve as “Centers 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. Commercialization of a beating heart solution could occur within
one to two years thereafter. A valve compatible in beating heart procedures would enlarge the Company’s
market opportunity by providing a solution for those patients who are poor candidates to endure conventional