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 cardiac surgery community and to patients, who ultimately benefit the most,” LivaNova international prez Roy Khoury said in a prepared statement.
“Through the Perfect trial, we reinforce our commitment to market expansion and take another important step toward meeting the increasing global need for advanced aortic valve solutions. We are eager to enhance patient care through expanded access to our truly sutureless valve technology,” LivaNova cardiac surgery biz GM Alistair Simpson said in a press release.
Earlier this month, LivaNova said it finalized the details in a deal to sell its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) in a deal worth $190 million.