LONDON--(BUSINESS WIRE)--LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced its Perceval® sutureless aortic heart valve received approval from the Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP). The Perceval valve met the CMS criteria for NTAP, including the demonstration of substantial clinical improvement over existing technologies. Beginning on Oct. 1, 2017, CMS has stated it will reimburse hospitals for the Perceval valve procedure with the Medicare Severity Diagnosis Related Group (MS-DRG) payment they normally receive, plus an additional payment of up to $6,110.23.
“We are pleased CMS recognized the significant value of the Perceval valve in the management of aortic valve disease,” said Brian Duncan, M.D., LivaNova’s Vice President of Medical Affairs for the Cardiac Surgery franchise. “Numerous publications in the medical literature have demonstrated the benefits of the Perceval valve compared to traditional surgical valves, and this decision will provide greater access to this important new technology. We look forward to continuing to provide the latest and most clinically beneficial technologies to cardiac surgeons and their patients.”
Clinical trial data has demonstrated the Perceval valve’s ability to optimize the overall surgical approach for cardiac surgeons through reduced procedure times, decreased postoperative complications and shorter hospital stays1. The Perceval valve is suitable for traditional surgery and also enables minimally invasive surgical approaches through its collapsible design and sutureless deployment. Engineered to restore natural valve performance, the Perceval valve features a super-elastic stent, which is able to adapt to the movement of the aorta during the cardiac cycle and provide excellent hemodynamics.
Perceval received U.S. Food and Drug Administration (FDA) approval in 2016, but has been in clinical use worldwide for 10 years and studied in more than 190 publications. Severe aortic stenosis affects over 500,000 Americans and 85,000 patients undergo aortic valve replacement each year2. LivaNova is committed to helping these patients by leading innovations in cardiac surgery that improve surgical outcomes and long-term survival.
1. Pollari et al; Annals of Thoracic Surgery (2014). 98: 611-7.
2. Aronow W, Ahn C, Kronzon I. Comparison of Echocardiographic Abnormalities in African-American, Hispanic, and White Men and Women Aged >60 Years. American Journal of Cardiology (2001). 1131-3.
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively.
For more information, please visit www.livanova.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of the Perceval valve and sales of our products; adverse changes in coverage or reimbursement amounts by the Centers for Medicare & Medicaid Services, state Medicaid agencies and private insurers; the presence or absence of intellectual property protection and potential patent infringement claims; maintaining compliance with government regulations; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; and other risks detailed from time to time in our filings with the Securities and Exchange Commission ("SEC"). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the year ended Dec. 31, 2016, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017.