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New Data on LivaNova Perceval Sutureless Aortic Valve Show Consistent Outcomes, Lower Procedure Times Compared to Sutured Valves
PERSIST-AVR study results presented at American Association for Thoracic Surgery Annual Meeting LONDON--(BUSINESS WIRE)-- LivaNova PLC (NASDAQ:LIVN), a
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[{"type":"text","content":"\nPERSIST-AVR study results presented at American Association for Thoracic Surgery Annual Meeting\n\n LONDON--(BUSINESS WIRE)--\nLivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, presented the first data from the Perceval® Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR) clinical study at the 100th Annual Meeting of the American Association of Thoracic Surgery (AATS). The study demonstrated that the Company’s sutureless surgical aortic valve, Perceval, is a reliable and essential technology to treat aortic valve disease.\n\n\nProf. Theodor Fischlein, Director of the Department of Cardiac Surgery at Paracelsus Medical University (PMU) Cardiovascular Center, Nuremberg Clinic, presented the new data. Commenting on the findings, Prof. Fischlein said, “The PERSIST-AVR trial showed that in patients with severe symptomatic aortic valve stenosis who were undergoing open-heart aortic valve replacement, a sutureless valve was noninferior to stented valves with respect to Major Adverse Cerebral and Cardiovascular Events (MACCE) at one year. These findings represent that Perceval should be considered as an important addition to any comprehensive valve program.”\n\n\nPERSIST-AVR is the first prospective, randomized, multi-center international trial comparing Perceval outcomes with those of standard sutured valves. The study comes after more than 300 peer-reviewed publications providing clinical results obtained with Perceval. From March 2016 to September 2018, 910 patients in 12 countries were enrolled in PERSIST-AVR. These patients had severe symptomatic aortic valve stenosis. They were undergoing open-heart aortic valve replacement (AVR), with and without coronary artery bypass grafting, and included patients receiving conventional or mini-sternotomy.\n\n\nPerceval was found to be noninferior to, or equally as safe and effective as, sutured AVR with respect to the primary endpoint demonstrating freedom from MACCE at 91.6% for the Perceval group and 92.0% for the sutured AVR group. Additionally, the rate of early death after one year was low (1% in both groups) considering the need for coronary artery bypass grafting in almost one-quarter of the patient cohort.\n\n\nThe study showed that the use of Perceval sutureless AVR resulted in significantly lower procedure times. Cardiopu...