LivaNova launches Chinese Perceval trial

LivaNova (NSDQ:LIVN) said today it launched a new trial of its Perceval sutureless aortic valve implant in China as it pursues Chinese Registration of the device. 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. “We greatly look forward to the possibility of making this innovative technology, which has demonstrated excellent outcomes in Europe and the United States, available to patients in China. The excellent hemodynamic characteristics of the Perceval valve, along with its suitability for less invasive approaches, makes introduction of this valve to the greater Chinese population particularly appealing,” principal investigator Dr. Shengshou Hu of Beijing’s Fu Wai Hospital said in a prepared release. The trial, dubbed the Perfect trial, is a prospective, single-arm study that aims to enroll 160 patients who will be followed up with at five and eight years at investigational sites in China. The primary endpoint for the trial is a one-year composite endpoint of major cardiac events as per adjudication from the Clinical Events Committee, the London-based company said. “This is a critical milestone in our ongoing commitment to provide access to Perceval within the Chinese car...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves LivaNova Source Type: news