Sorin has announced that it has received conditional approval from the Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) study of its Perceval S sutureless aortic valve. The primary objective of the prospective, non-randomised trial is to demonstrate the safety and effectiveness of the valve in support of receiving FDA pre-market approval clearance.
According to a company press release, Perceval S is a bioprosthetic valve designed to replace a diseased native or malfunctioning prosthetic aortic valve in patients with aortic stenosis using either traditional or minimally invasive heart surgery. The press release reported that due to its original characteristic of allowing sutureless positioning and anchoring at the implantation site, the aortic valve will offer significant advancements in surgical aortic valve replacement technology.
The valve is designed to be implanted through either a traditional open heart surgical approach or through a minimally invasive cardiac surgery partial sternotomy or right mini-thoracotomy implantation technique. Minimally invasive cardiac techniques are increasingly important for aortic valve regurgitation because they reduce surgical trauma and morbidity which is an important consideration for the growing number of patients.
“We are eager to provide this innovative treatment to a wider patient population in the USA and to support the cardiac surgeon community in performing more and more minimally invasive cardiac surgery procedures,” said Michel Darnaud, Sorin Group, president, Cardiac Surgery Business Unit.