New Sutureless Valve Data Presented at STS

Last week’s Society of Thoracic Surgeons 53rd Annual Meeting (STS), in Houston, saw new safety, efficiency and performance data presented on the LivaNova Perceval™ sutureless valve.

Background

LivaNova PLC was spawned from the coming together of Sorin and Cyberonics. Its Perceval sutureless valve, the first-ever, truly sutureless surgical valve designed for patients requiring an aortic valve replacement (AVR) has been implanted in more than 20,000 patients in over 310 hospitals in 34 countries across the world.

The newly presented study, Aortic Valve Replacement With Sutureless Perceval Bioprosthesis: Single-Center Experience With 617 Implants, analyzed patients who underwent AVR with the Perceval bioprosthesis. The study found that AVR procedures conducted with he valve resulted in low mortality and excellent hemodynamic performance for patients. This is the largest single center experience reported with Perceval.

Specifically, the study found that Perceval, with its safe and reproducible features, allowed surgeons to employ a minimally invasive approach during AVR procedures. At follow-up at approximately 16 months, freedom from reoperation was 99% and patient survival was 91.3%.

Investigator  comments

“As one of the latest solutions in valve replacement surgery, the Perceval sutureless valve optimizes the overall surgical approach for surgeons. In the presented analysis, implantation with Perceval allowed surgeons to perform minimally invasive approaches with shorter procedure times, specifically reducing the cross-clamp and cardiopulmonary bypass time, which can lead to faster recovery times for patients,” said Dr. Marco Solinas, MD, Cardiac Surgeon at G. Monasterio Tuscany Foundation, Massa, Italy.

Company comments

“These positive results reinforce findings from previous studies for Perceval1, the only truly sutureless valve designed for patients requiring surgical aortic valve replacement,” said Brian Duncan, MD, Vice President, Medical Affairs, Cardiac Surgery at LivaNova. “With the foundation of advancing technology and transforming lives, LivaNova is committed to delivering advanced solutions for cardiac surgery and we look forward to continuing the expansion of Perceval’s clinical evidence base and its growing use in the international cardiac surgery community.”

Source: Business Wire

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