dimarts, 8 de març del 2016

LivaNova touts 1st U.S. implants of Perceval sutureless valve

LivaNovaLivaNova (NSDQ:LIVN) today announced the 1st U.S. implantation of its Perceval sutureless aortic valve replacement.

The implantation, which took place last week, was headed by Dr. Douglas Johnson and Dr. Eric Roselli at the Cleveland Clinic in Ohio, with the patient receiving 2 valves during the operation.

“The availability of a sutureless valve optimizes surgical options to treat aortic valve disease, including minimally invasive approaches. A collapsible device increases the surgeon’s visibility of critical structures during the procedure, enhancing safety. This enables a quicker procedure, and the potential to further improve patient outcomes,”  Dr. Eric Roselli of the Cleveland Clinic said in a press release.

The company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing the Perceval valve result in shorter intensive care unit stays, reduced ventilation time and less blood transfusions.

“The 1st U.S. implant of Perceval is a significant milestone for LivaNova, but more importantly, is evidence of the rising innovation in cardiac surgery. With a commitment to provide advanced therapeutic solutions to surgeons worldwide, we look forward to Perceval’s rapid adoption among the U.S. cardiac surgery community,” Livanova cardiac surgery biz prez Michel Darnaud said in prepared remarks.

In January, the FDA approved LivaNova’s Perceval sutureless replacement heart valve. London-based LivaNova said it planned to begin commercial distribution of the Perceval valve, which is designed to replace the heart’s aortic valve using a self-anchoring frame.

The Perceval device won a nod from Health Canada last summer and CE Mark approval in the European Union for the XL version of the valve in November 2013.

The post LivaNova touts 1st U.S. implants of Perceval sutureless valve appeared first on MassDevice.



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