LONDON--(BUSINESS WIRE)--LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, will present new findings from its 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).
Prof. Theodor Fischlein, Director of the Department of Cardiac Surgery at Paracelsus Medical University (PMU) Cardiovascular Center, Nuremberg Clinic, Germany will present new data from the PERSIST-AVR study, which will be available on Friday, May 22.
From March 2016 to September 2018, 910 patients were randomized in 47 centers in 12 countries for the PERSIST-AVR study, a prospective, randomized, multi-center international trial. The study objective is to assess the safety, efficacy and noninferiority of the Perceval valve compared with standard stented bio-prostheses using a conventional or mini-sternotomy approach in patients with severe symptomatic aortic valve stenosis. This is the first public presentation of PERSIST-AVR data and will focus on results related to the primary outcome variable: freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) at one year.
“With aortic stenosis being the most common heart valve disease in the elderly1, minimally invasive options, such as Perceval, that improve outcomes and quality of life stand to impact healthcare systems worldwide,” said Dr. Brian Duncan, Vice President of Medical Affairs at LivaNova. “We look forward to sharing these new findings regarding the safety and efficacy of Perceval as compared to standard sutured aortic valves.”
LivaNova obtained CE Mark for Perceval in 2011 followed by U.S. Food and Drug Administration approval in 2016. To date, more than 50,000 patients worldwide have been treated with the Perceval valve.
To learn more about Perceval, visit www.livanova.com.
LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 4,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.
For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding Perceval and findings from the PERSIST-AVR clinical study. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by any risk factors contained in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
1 Bouma BJ, van den Brink RBA, van der Meulen JHP et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999 Aug; 82: 143–8.