FRAMINGHAM, Mass., June 4, 2014 /PRNewswire/ -- HeartWare
International, Inc. (Nasdaq: HTWR) announced that on June 3, 2014 it received a warning letter from
the U.S. Food and Drug Administration (FDA) resulting from an
inspection of the company's operations, development and
manufacturing facility in Miami Lakes,
Florida, conducted in January
2014.
The FDA letter cites four categories for the company to address:
procedures for validating device design, including device labeling;
procedures for implementing corrective and preventive action
(CAPA); maintaining records related to investigations; and
validation of computer software used as part of production or
quality systems.
The letter issued by FDA does not require any action by
physicians or patients and does not restrict use of HeartWare's
devices.
HeartWare takes this matter seriously and will respond to the
letter within the required 15 days. The company expects to
implement new and enhanced systems and procedures, and will perform
additional actions as may be required to resolve the issues raised
in the FDA communication.
"HeartWare is committed to providing the highest quality
products in compliance with FDA regulations to ensure the safety
and welfare of patients who rely on our devices, and we are
dedicating the resources necessary to address the items discussed
in the letter," said Doug Godshall,
President and Chief Executive Officer.
About HeartWare International
HeartWare International develops and manufactures miniaturized
implantable heart pumps, or ventricular assist devices, to treat
patients suffering from advanced heart failure. The
HeartWare® Ventricular Assist System features the
HVAD® pump, a small full-support circulatory assist
device designed to be implanted next to the heart. The
HeartWare System is approved in the
United States for the intended use as a bridge to cardiac
transplantation in patients who are at risk of death from
refractory end-stage left ventricular heart failure. For
additional information, please visit the company's website at
www.heartware.com.
Forward-Looking Statements
This announcement contains forward-looking statements that are
based on management's beliefs, assumptions and expectations and on
information currently available to management. All statements
that address operating performance, events or developments that we
expect or anticipate will occur in the future are forward-looking
statements, including our ability to timely and effectively respond
to the FDA warning letter and the amount and nature of resources
required to address the issues raised in the warning letter.
Management believes that these forward-looking statements are
reasonable as and when made. However, you should not place
undue reliance on forward-looking statements because they speak
only as of the date when made. HeartWare does not assume any
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as may be required by federal securities laws
and the rules and regulations of the Securities and Exchange
Commission. HeartWare may not actually achieve the plans,
projections or expectations disclosed in forward-looking
statements, and actual results, developments or events could differ
materially from those disclosed in the forward-looking
statements. Forward-looking statements are subject to a
number of risks and uncertainties, including without limitation
those described in Part I, Item 1A. "Risk Factors" in HeartWare's
Annual Report on Form 10-K filed with the Securities and Exchange
Commission. HeartWare may update risk factors from time to
time in Part II, Item 1A "Risk Factors" in Quarterly Reports on
Form 10-Q, Current Reports on Form 8-K, or other filings with the
Securities and Exchange Commission.
For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864
SOURCE HeartWare International, Inc.