LivaNova PLC Provides Update on FDA Warning Letter
(Thomson Reuters ONE) -
LONDON, Jan. 05, 2016 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN)
(the "Company") received a Warning Letter dated December 29, 2015, from the
United States Food and Drug Administration ("FDA") alleging certain violations
of FDA regulations applicable to medical device manufacturers at its Munich,
Germany and Arvada, Colorado facilities.
The Company currently believes that less than 1 percent of 2016 consolidated
sales could be impacted by this Warning Letter, and that FDA's concerns can be
resolved without a material impact on the Company's financial results. Further
meetings are planned with FDA in order to clarify certain aspects of the Warning
Letter.
FDA inspected the Company's Munich facility from August 24, 2015, to August
27, 2015, and its Arvada facility from August 24, 2015, to September 1, 2015.
On August 27, 2015, FDA issued a Form 483 identifying two observed non-
conformities with certain regulatory requirements at the Munich facility. The
Company did not receive a Form 483 in connection with FDA's inspection of the
Arvada facility.
Following the receipt of the Form 483, the Company provided written responses to
FDA describing corrective and preventive actions that were underway or to be
taken to address FDA's observations at the Munich facility. The Warning Letter
responded in part to the Company's responses and identified other alleged
violations not previously included in the Form 483. The Company will continue
to work diligently to remediate FDA's inspectional observations for the Munich
facility as well as the additional issues identified in the Warning Letter. The
Company takes these matters seriously and intends to respond timely and fully to
FDA's requests.
The Warning Letter states that the 3T Heater Cooler devices, and other devices
manufactured by the Company's Munich facility, are subject to refusal of
admission into the United States until resolution of the issues set forth in the
Warning Letter. FDA has informed the Company that the import alert is, at the
present time, limited to the 3T Heater Cooler devices but that the agency
reserves the right to expand the scope of the import alert if future
circumstances warrant such action. The Warning Letter did not request that
existing users cease using the 3T Heater Cooler device, and to help clarify the
Warning Letter, the Company has issued an informational Customer Letter. The
Company is working constructively with FDA to reduce the impact of this decision
on existing U. S. customers of 3T Heater Cooler devices, and the Company will
promptly communicate to its customers and users of the 3T Heater Cooler any
updates agreed upon with FDA in this regard. Manufacturing and shipment of all
of the Company's products other than the 3T Heater Cooler are unaffected by this
limitation at the present time and will continue as normal.
Lastly, while the Warning Letter states that premarket approval applications for
Class III devices to which the Quality System regulation deviations are
reasonably related will not be approved until the violations have been
corrected, the Company notes that this Warning Letter only specifically names
the Munich and Arvada facilities, which do not manufacture or design devices
subject to premarket approval.
About LivaNova
LivaNova PLC, headquartered in London, UK, is a global medical technology
company formed by the merger of Sorin S.p.A, a leader in the treatment of
cardiovascular diseases, and Cyberonics Inc., a medical device company with core
expertise in neuromodulation. LivaNova transforms medical innovation into
meaningful solutions for the benefit of patients, healthcare professionals, and
healthcare systems. The company employs approximately 4,500 employees
worldwide. With a presence in more than 100 countries, LivaNova operates as
three business units: Cardiac Rhythm Management, Cardiac Surgery, and
Neuromodulation, with operating headquarters in Clamart (France), Mirandola
(Italy) and Houston (U.S.A.), respectively.
LivaNova is listed on NASDAQ and listed on the Official List of the UK's
Financial Conduct Authority and traded on London Stock Exchange (LSE) under the
ticker symbol "LIVN".
For more information, please visit www.livanova.com, or contact:
Investor Relations and Media:
Investor Relations: Greg Browne
Vivid Sehgal Senior Vice President, Finance
Chief Financial Officer Phone: +1 (281) 228-7262
e-mail: Fax: +1 (281) 218-9332
investor.relations(at)livanova.com e-mail:
corporate.communications(at)livanova.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: LivaNova plc via GlobeNewswire
[HUG#1976880]
Datum: 05.01.2016 - 20:37 Uhr
Sprache: Deutsch
News-ID 442572
Anzahl Zeichen: 5757
contact information:
Town:
London
Kategorie:
Business News
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