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

LONDON, Feb. 29, 2016 (GLOBE NEWSWIRE) -- LivaNova, PLC (NASDAQ:LIVN) (LSE:LIVN), 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." ^{1 , 2 , 3 ,4,5,6}

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."

About LivaNova

LivaNova PLC, headquartered in London, UK, is a global medical technology company formed by the merger of Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and Cyberonics Inc., a medical device company with core expertise in neuromodulation. LivaNova transforms medical innovation into meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.  The company employs approximately 4,500 employees worldwide. With a presence in more than 100 countries, LivaNova operates as three business units: Cardiac Rhythm Management, Cardiac Surgery, and Neuromodulation, with operating headquarters in Clamart (France), Mirandola (Italy) and Houston (U.S.A.), respectively.

LivaNova is listed on NASDAQ and listed on the Official List of the UK's Financial Conduct Authority and traded on London Stock Exchange (LSE) under the ticker symbol "LIVN".

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¹  Repossini A, Rambaldini M, Lucchetti V, et al. Early clinical and hemodynamic results after aortic valve replacement with the Freedom SOLO bioprosthesis (experience of Italian multicenter study). Eur J Cardiothorac Surg. 2012;41(5):1104-111.  
²  Beholz S, Repossini A, Livi U, et al. The Freedom SOLO Valve for Aortic Valve Replacement: Clinical and Hemodynamic Results from a Prospective Multicenter Trial. The Journal of Heart Valve Disease. 2010;19:115-123. 
³  Horst M, Easo J, Hölzl PPF, et al. The Freedom Solo Valve: Mid-Term Clinical Results with a Stentless Pericardial Valve for Aortic Valve Replacement. The Journal of Heart Valve Disease. 2011;20:704-710.  
⁴  Clinical Experience With the Freedom Solo Stentless Aortic Valve in 277 Consecutive Patients. 
Thalmann M, Kaiblinger J, Krausler R, Pisarik H, Veit F, Taheri N, Kornigg K, Dinges C, Grabenwöger M, Stanger O. Ann Thorac Surg. 2014 Oct;98(4):1301-7. 
⁵  Clinical and haemodynamic outcomes in 804 patients receiving the Freedom SOLO stentless aortic valve: results from an international prospective multicentre study.  
Grubitzsch H, Wang S, Matschke K, Glauber M, Heimansohn D, Tan E, Francois K, Thalmann M.  
Eur J Cardiothorac Surg. 2015 Mar;47(3):e97-e104 
⁶  Long term durability and haemodynamic performance of freedom solo stentless valve for aortic valve replacement: a european, multicenter experience". Repossini et al. Presented at AHA Congress - Nov 2015

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