LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, announced on 2/25/19 that given the increasing viability of Valve-in-Valve (ViV) procedures, it has added new safety and technical information to the Perceval U.S. Instructions For Use (IFUs). This addition was made following completion of the Company’s application to the U.S. Food and Drug Administration.
The use of transcatheter valves in failed bioprostheses has recently been recognized in both American and European Guidelines as an option for patients at high surgical risk. LivaNova is making this new information available to support clinicians considering whether or not to perform a ViV procedure on a Perceval foundation. The Company implemented the change to provide heart teams with greater insight on how Perceval can accommodate future transcatheter valves, presenting even broader treatment options for patients.
This is becoming more important as patients with replace valves outlive their original valves lifespan. The transcather ViV approach offers a much less invasive option to patients needing to replace failing valves.
“As a cardiologist, I appreciate the proactive approach LivaNova is taking to support professionals who are considering the feasibility of ViV procedures,” said Dr. Danny Dvir, cardiologist at University of Washington, Seattle, and Chairman of the American Institute of Valvular Research. “The literature and the global VIVID registry, so far, show no reports of coronary ostia obstruction, which is encouraging. In addition, hemodynamic results of ViV within Perceval bioprostheses are very promising. ViV is a key way to give patients greater choice if the time comes to replace a surgical prosthesis.”
“Giving Perceval patients the option to receive a transcatheter valve offers them access to more treatment choices and less invasive possibilities,” said Alistair Simpson, LivaNova General Manager of Cardiac Surgery. “By providing heart teams with this information for Valve-in-Valve applications, we are further demonstrating the role of Perceval as an essential component to any valve program.”