Self-Anchoring Aortic Valve Reduces Open Heart Surgery Time

An innovative sutureless aortic valve reduces surgical time for both isolated and complex aortic valve replacement procedures, with cross-clamp times typically reduced by at least 50%.

The Perceval aortic valve is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves when performing an open surgical procedure. The valve is made of bovine pericardium, and is mounted on a super-elastic self-anchoring alloy frame. This enables the surgeon to replace the diseased valve without the need for sutures to secure it on place, thus significantly reducing the time spent in open heart surgery and minimizes the risk for thromboembolic stroke or iatrogenic aortic dissection.

Among the features of the Perceval are a reduced collapsed profile, which prevents trauma to the aortic wall and enables a full and direct view; precise positioning thanks to temporary sutures that guide the valve along the annulus axis, even in narrow spaces; adaptive movement in rhythm with the cardiac cycle; and, thanks to the absence of a suturing ring, the geometric orifice area is maximized, providing excellent hemodynamics with stable results over time. The Perceval aortic valve is a product of LivaNova (London, United Kingdom), and has been approved by the US Food and Drug Administration (FDA).

“We are excited to bring this important product to the US market, which will provide real value to patients and physicians,” said André-Michel Ballester, CEO of LivaNova. “The rapid acceptance of Perceval in Europe, an increasing number of positive publications on the product, and the solid preparation of our US sales team, all provide a strong base for the achievement of our short and long term plans.”

The company is hoping the device can overcome the rising trend toward implantation of transcatheter aortic valve replacement (TAVR), a procedure that enables the placement of a balloon expandable aortic heart valve into the body via a catheter-based transfemoral delivery system. It is designed to provide an alternative treatment to patients in whom traditional open-heart surgery cannot be performed.

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