LONDON--(BUSINESS WIRE)--Aug. 4, 2017--
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.
For more information, visit www.livanova.com
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170804005543/en/
Source: LivaNova PLC
LivaNova PLC Investor Relations and Media
Karen King, +1
Vice President, Investor Relations & Corporate
Deanna Wilke, +1 (281) 727-2764
External Communications Manager