The valve, which is designed to hold itself in place with a self-anchoring frame, is under review at the FDA now that Sorin has a U.S. investigational device exemption trial under its belt, the company said.
“Sorin is committed to innovation that improves patient outcomes, enhances surgical technique and delivers value for hospitals and the health system overall,” cardiac surgery president Michel Darnaud said in prepared remarks. “We believe Perceval meets each of these criteria and has the potential to become the standard of care for patients who require surgical valve replacement procedures. We look forward to working with the surgical community in Canada to bring this important new option to patients.”
“Perceval represents a major advance in surgical aortic valve technology because it reduces aortic cross-clamp times and provides outstanding hemodynamic performance,” added Dr. Theodor Fischlein of the Paracelsus Medical University Cardiovascular Center in Nuremberg, Germany. “A broad range of patient types can benefit from a sutureless approach, including higher-risk patients and those undergoing a concomitant procedure.”
Perceval won expanded CE Mark approval in the European Union in April 2014, expanding the addressable patient population from just people over age 65 to all adults with aortic stenosis or steno-insufficiency disease.
Sorin has high hopes for the valve, with CEO André-Michel Ballester saying he expects the device to help accelerate revenue growth in the 2nd half of 2015.