Boston Scientific has completed enrolling patients for the prospective, single-arm and feasibility Reprise I clinical trial to assess the acute safety of the Lotus Aortic Valve system.
Reprise I trial principal investigator and MonashHeart director Ian Meredith said the Lotus Aortic Valve system offers the ability to position the valve during deployment with the added ability to reposition and retrieve the device if necessary.
"The valve functions remarkably early in the deployment process, offering interventional cardiologists greater control over the deployment," Meredith added.
The primary endpoint of the Reprise I trial is defined as clinical procedural success without in-hospital major adverse cardiovascular or cerebrovascular events (MACCE) through discharge or seven days post-procedure.
Secondary endpoints include successful repositioning of the Lotus Valve system and incidence of aortic valve regurgitation.
Boston Scientific global chief medical officer Keith Dawkins said the company is encouraged by positive feedback from the Reprise I investigators and look forward to the results of the study.
"The Lotus Aortic Valve System is a truly differentiated second-generation TAVR technology designed to simplify and improve the entire aortic valve replacement procedure," Dawkins added.
Boston Scientific expects to begin enrollment for the Reprise II study later in 2012, which is designed to assess the safety and performance of the Lotus Aortic Valve system in 120 patients.
The company said data from the trial will be used to support CE Mark and other international regulatory approvals.