Another one of our long term “follows”, cardiovascular technologies company LivaNova, PLC, has announced the first U.S. implantation of the Perceval valve, the sutureless biological aortic replacement valve.
Background
LivaNova, formed from the merger of Sorin with Cyberonics, saw its Perceval sutureless valve gain FDA approval in January as we reported here.
Already implanted in more than 15,000 patients in over 310 Hospitals worldwide, Perceval helps reduce the complexity of aortic valve replacement (AVR) by enhancing the speed and efficiency of the procedure while providing optimized hemodynamic performance. The Perceval valve is designed for any patient requiring an AVR procedure, including high-risk and complex patients. Based on the premise that by not featuring a rigid sewing ring, the valve optimizes the effective orifice area resulting in excellent hemodynamics.
Clinical outcome analysis suggest that when compared to traditional surgical valves, the Perceval valve procedures lead to shorter Intensive Care Unit stays, ventilation time reduction and less blood transfusion. This contrives to provide benefits to a broad range of patients, including high-risk and complex cases. Overall, Perceval has been shown to lower overall procedural cost compared to traditional sutured valves.
The newly reported U.S implants were performed last week, two valves being implanted by Douglas Johnston, M.D., and Eric Roselli, M.D., Staff Cardiac Surgeons in the Miller Family Heart & Vascular Institute at Cleveland Clinic, in Cleveland, Ohio.
Physician comments
“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,” said Dr. Eric Roselli, Director of the Aorta Center, Cleveland Clinic Department of Thoracic and Cardiovascular Surgery.
Company comments
“The first U.S. implant of Perceval is a significant milestone for LivaNova, but more importantly, is evidence of the rising innovation in cardiac surgery,” said Michel Darnaud, President, Cardiac Surgery Business Unit, LivaNova. “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.”
Source: LivaNova, PLC
published: March 9, 2016 in: Cardio, Clinical Studies/Trials