The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to Sorin Group to initiate a prospective, non-randomised, multi-centre clinical study of its bioprosthetic valve.
The Perceval S sutureless aortic tissue valve has been developed for patients with aortic stenosis, and is designed as a replacement for a malfunctioning prosthetic or diseased native aortic valve.
The valve is implanted through traditional open-heart surgery or a minimally invasive cardiac surgery (MICS), either as a partial sternotomy or right mini-thoracotomy implantation.
The device, which allows sutureless positioning and anchoring at the implantation site, also offers significant advancements in surgical aortic valve replacement (AVR) technology by reducing surgical trauma and morbidity.
Sorin also claims that the implant has proven to be a revolution in cardiac surgery, by optimising both operating time and clinical outcomes.
The trial, which will involve up to 25 US centres, is designed to evaluate the safety and effectiveness of the Perceval S valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Sorin Group cardiac surgery business unit president Michel Darnaud said; "We are eager to provide this innovative treatment to a wider patient population in the US and to support the cardiac surgeon community in performing more and more MICS procedures."
The device was initially introduced in the European market in 2011.