Sorin Group has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a clinical study of its PERCEVAL S sutureless aortic tissue valve.
The bioprosthetic valve is designed to replace a diseased native or malfunctioning prosthetic aortic valve in patients with aortic stenosis.
Implanted through either a traditional open heart surgical approach or through a minimally invasive cardiac surgery (MICS), the device allows sutureless positioning and anchoring at the implantation site.
The device, which was initially introduced in the European market in 2011, also offers significant advancements in surgical aortic valve replacement (AVR) technology by reducing surgical trauma and morbidity.
The implant has proven to be a revolution in cardiac surgery, optimizing both operating time and clinical outcomes, claims the company.
The prospective, non-randomised, multi-center trial will 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 U.S. and to support the cardiac surgeon community in performing more and more MICS procedures."
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