LivaNova PLC Receives Regulatory Approval in Japan for the Solo Smart Stentless Tissue Aortic Valve

Solo Smart is a Native-Like Aortic Valve Replacement Option With Excellent Hemodynamic Performance and Clinical Outcomes

LONDON, LivaNova, PLC, a global medical technology company and a leader in the treatment of cardiovascular diseases, today announced that it has received approval from Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for its Solo Smart stentless tissue valve, the only valve designed to provide superior hemodynamics with the ease of a stented bioprosthesis implantation. 

Designed from bovine pericardium, the Solo Smart valve is fully biological with no synthetic material added, allowing the valve to mimic the healthy native aortic valve. Solo Smart maximizes the blood flow and delivers excellent hemodynamic performance and patient outcomes while providing a simplified implant procedure method with a removable stent for straightforward implantation and optimal positioning. 

“Since their introduction in the 1990s, stentless bioprosthetic valves have represented a major stride in valve design and hemodynamic performance for aortic valve replacement options,” said Alberto Repossini, M.D., Cardiac Surgery University of Brescia, Spedali Civili, Brescia, Italy. ”Solo Smart is a unique prosthesis with a temporary stent removed during its implantation for optimal positioning.  Once the stent is removed, Solo Smart becomes an entirely stentless valve, providing low pressure gradients and large orifice areas.”

Available also in Europe and the U.S., the Solo Smart stentless valve is designed for patients with an active lifestyle, those who are at risk of PPM (Patient Prosthesis Mismatch) or require a concomitant aortic valve replacement procedure.

“In collaboration with our established partner, Japan Lifeline, LivaNova is pleased to introduce the Solo Smart stentless valve for aortic valve replacement in Japan,” said Michel Darnaud, President, Cardiac Surgery Business Unit, LivaNova.  “With Solo Smart valve and its long-term data paired with simplified implantability, surgeons are empowered with state-of-the-art technology and the confidence to perform AVR procedures more effectively.”

Source: LivaNova