LivaNova highlighted Thursday three studies into the effectiveness and value of its sutureless aortic valve, Perceval.
The studies include a 300-patient trial LivaNova ran under an FDA IDE to show the safety and effectiveness of Perceval.
LivaNova thinks the study, which linked Perceval to positive one-year outcomes, and device cost support greater use of the aortic valve.
LivaNova has highlighted the performance of Perceval as a bright spot at its stuttering heart valve unit in recent financial results. Throughout much of fiscal 2018, LivaNova reported "strong growth" in sales of Perceval but nonetheless saw its heart valve business contract each quarter as a result of ongoing declines in revenues from mechanical and traditional tissue valves.
Perceval, which won FDA approval in 2016, is designed to replace diseased valves or malfunctioning prosthetic aortic valves. The design supports minimally-invasive surgical techniques and, owing to its sutureless positioning and anchoring, can cut the time patients spend in cardiopulmonary bypass.
That pitch has resonated with some surgeons but the growth of Perceval has proved insufficient to offset declines in other parts of the heart valve business. Third quarter heart valve sales came in at $32.5 million, down 5.8% year over year on a constant currency basis.
Faced with the need to build on the early progress of Perceval, LivaNova has put the device through multiple studies, several of which were published in journals in the second half of last year. LivaNova highlighted three studies published over that period in a statement talking up the effectiveness and value of its device this week.
The key efficacy data come from the aforementioned IDE trial. At the one-year follow up, LivaNova saw a statistically-significant drop in left ventricular mass index, a variable associated with increased mortality at high levels, and improved scores on a health-related quality of life scale.
The other studies highlighted by LivaNova looked at the economic impact of sutureless aortic valve replacement. One study associated sutureless valves with lower in-hospital and long-term costs than transcatheter aortic valve implants. The other study found the overall cost of hospitalization for sutureless and sutured patients was comparable.