LivaNova Announces Availability of Safety and Technical Information for Valve-in-Valve Procedures on Perceval Platform

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.¹ 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.

“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.”

Perceval combines the versatility of a sutureless valve, with more than 10 years of clinical experience. Its stent design makes it well suited for different applications and a broad patient population. This is particularly relevant for ViV procedures:

• The Perceval stent shape provides clear visibility and landmarks to facilitate transcatheter valve positioning.
• The nitinol stent allows for even circumferential expansion to accommodate future transcatheter valves.
• Perceval has a large internal diameter, providing more choices for future transcatheter valve selection.

“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.”

Important Safety Information

EUROPE: The Perceval prosthesis is indicated for the replacement of diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The prosthesis is indicated for use in adult patients who are diagnosed to have aortic valve stenosis or steno-insufficiency. USA: The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. CANADA: The Perceval S bioprosthesis is intended for use in patients aged ≥ 65 years when the aortic valve pathology is in an advanced stage to require the replacement of the native or malfunctioning previously implanted prosthesis. AUSTRALIA: Perceval S prosthesis is indicated for the replacement of a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The prosthesis is indicated in patients who meet the following criteria: 1) subjects of age ≥ 65 years 2) subjects with aortic valve stenosis or steno-insufficiency.

TOP POTENTIAL SIDE EFFECTS: Central and paravalvular leak, cardiac disorders, structural valve deterioration, thromboembolism, reoperation. The safety and efficacy of valve-in-valve procedures in a Perceval valve have not been established. ¹The decision of performing Valve-in-Valve procedures is at the discretion of the cardiologist and/or hospital’s heart team, following careful assessment of the individual circumstances of each patient. Currently, no long-term data exists to support the efficacy of the procedure. Valve-in-Valve procedures in a Perceval valve should be performed according to indications provided by the transcatheter valve manufacturer.

MRI conditional.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a presence in more than 100 countries worldwide. The Company currently employs approximately 4,000 employees. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.

For more information, please visit www.livanova.com.

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