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LONDON–(BUSINESS WIRE)–Sep 10, 2018–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, welcomes the afresh adapted interventional procedures advice for sutureless aortic valve backup issued by the U.K. National Institute for Health and Care Excellence (NICE), which states that sutureless aortic valve backup is an another to accepted surgical aortic valve replacement. The NICE advice comes as LivaNova completes acceptance for a all-around aortic valve backup analytic balloon comparing the allowances of sutureless against accepted aortic valve backup for aortic stenosis.
Based on its evaluation, NICE concludes that the sutureless aortic valve backup action may be faster than the accepted procedure, abbreviation cardiopulmonary and aortic cross-clamp times. Additionally, acceptable affirmation was begin to abutment the assurance and adeptness of the sutureless procedure. The advice was abreast by a absolute appraisal of abstract and abundant analysis of affirmation from assorted sources, including six analytical reviews and meta-analyses and two case series. The analysis additionally included accommodating acknowledgment and advised outcomes such as affection of life, valve backbone and analytic improvements.
Concurrently, LivaNova completed acceptance for the Per ceval ®S utureless I mplant vs. St andard A ortic V alve R eplacement (PERSIST-AVR) abstraction with added than 900 patients from 47 centers in 12 countries. While the aboriginal abstraction agreement was for 1,234 patients, the addition of an avant-garde adaptive architecture accustomed for a bargain sample admeasurement and the adeptness to assay abstracts earlier. PERSIST-AVR, which began in April 2016, is the alone worldwide, prospective, randomized, multi-center balloon comparing the LivaNova Perceval sutureless aortic valve with accepted sutured bioprostheses in patients with aortic valve disease.
The arch board for PERSIST-AVR are Professor Theodor Fischlein, M.D., Ph.D., Paracelsus Medical University Cardiovascular Center, Nuremberg, Germany, and Professor Roberto Lorusso, M.D., Ph.D., Cardio-Thoracic Surgery Department, Maastricht University Medical Centre, Maastricht, The Netherlands. “The acceleration of application and all-around assurance is a solid account for the acceptance of Perceval about the world,” said Fischlein. Lorusso added, “This absolution of abstracts will absolutely abutment our circadian acquaintance of aortic valve backup with Perceval.”
Since 2007, Perceval has been built-in in bags of patients with aortic valve ache to advice advance their lives.
“Our Perceval sutureless aortic valve is one of our important advance drivers and continues to action surgeons and patients a accurate another with different allowances compared to acceptable aortic valve replacement,” said Alistair Simpson, LivaNova General Manager of Cardiac Surgery. “The adapted NICE advice and achievement of our PERSIST-AVR analytic balloon acceptance are key milestones that will abutment an alike greater acceptance rate.”
For added advice on the NICE guidance, appointment https://www.nice.org.uk/guidance/ipg624.
LivaNova PLC is a all-around medical technology aggregation congenital on about bristles decades of acquaintance and a adamant charge to advance the lives of patients about the world. LivaNova’s avant-garde technologies and advance treatments accommodate allusive solutions for the account of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a attendance in added than 100 countries worldwide. The Aggregation currently employs about 4,000 employees. LivaNova operates as two businesses: Cardiac Surgery and Neuromodulation, with operating address in Mirandola (Italy) and Houston (U.S.), respectively.
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Safe Harbor Statement
This account absolution contains advanced statements aural the acceptation of Area 27A of the United States Securities Act of 1933, as amended, and Area 21E of the United States Securities Exchange Act of 1934, as amended. Advanced statements are not absolute facts but are based on assertive assumptions of administration and call LivaNova’s approaching plans, strategies and expectations. Advanced statements can about be articular by the use of advanced terminology, including, but not bound to, “may,” “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” “believe,” “will,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “forecast,” or variations of these agreement and agnate expressions, or the abrogating of these agreement or agnate expressions. Advanced statements independent in this account absolution are based on advice anon accessible to LivaNova and assumptions that LivaNova believes to be reasonable, but are inherently uncertain. As a result, LivaNova’s absolute results, achievement or achievements may alter materially from those bidding or adumbrated by these advanced statements, which are not guarantees of approaching achievement or accomplishments that may be taken by LivaNova and absorb accepted and alien risks, uncertainties and added factors that are, in some cases, above LivaNova’s control. You should anxiously accede the risks and uncertainties that affect LivaNova, including those declared in the “Risk Factors” area of LivaNova’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and added abstracts filed from time to time with the United States Securities and Exchange Commission.
All advice in this account absolution is as of the date of its release. LivaNova does not undertake or accept any obligation to amend about any of the advanced statements in this account absolution to reflect absolute results, new advice or approaching events, changes in assumptions or changes in added factors affecting advanced statements, except to the admeasurement appropriate by applicative law. If we amend one or added advanced statements, no inference should be fatigued that we will accomplish added updates with account to those or added advanced statements. We attention you not to abode disproportionate assurance on any advanced statements, which are fabricated alone as of the date of this account release.
View antecedent adaptation on businesswire.com:https://www.businesswire.com/news/home/20180910005094/en/
CONTACT: LivaNova PLC
Deanna Wilke, 1 (281) 727-2764
Director, Corporate Communications
KEYWORD: UNITED KINGDOM UNITED STATES EUROPE NORTH AMERICA TEXAS
INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS HOSPITALS MEDICAL DEVICES RESEARCH FDA SCIENCE
SOURCE: LivaNova PLC
Copyright Business Wire 2018.
PUB: 09/10/2018 09:00 AM/DISC: 09/10/2018 09:01 AM
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