The London-based 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.
“With this approval for Perceval, an innovative and trusted valve platform, we are able to provide patients and clinicians in Japan with a new option for aortic heart valve replacement,” LivaNova Japan prez Noriaki Kawana said in a prepared statement.
“At LivaNova, we are committed to enhancing patient care around the world, and will continue to address the increasing global need for advanced aortic valve solutions,” LivaNova int’l prez Roy Khoury said in a press release.
LivaNova won CE Mark approval for the Perceval valve in 2011, and FDA approval in January 2016.
In March, LivaNova said it launched a new trial of its Perceval sutureless aortic valve implant in China as it pursues Chinese regulatory clearance of the device.