|[August 21, 2014]
FDA Approves Changes to Manufacturing Process for Covidien's Pipeline™ Embolization Device
DUBLIN, Ireland --(Business Wire)--
plc (NYSE: COV) today announced that the U.S. Food and Drug
Administration (FDA) has approved changes to the manufacturing process
for the polytetrafluoroethylene (PTFE) coating on the delivery wire of
the company's Pipeline™ embolization device.
On April 1, 2014, Covidien voluntarily recalled certain lots of Pipeline
and Alligator™ retrieval devices on which the PTFE coating applied to
the delivery wire could delaminate and detach from the devices. In the
months since, Covidien worked with its suppliers to develop and qualify
changes to the coating process.
Given the timely resolution, the recall is expected to have only a
slight negative effect on sales and earnings in the fourth-quarter of
Covidien learned of the PTFE coating issue that led to the recall
through its ongoing internal product testing and alerted customers to
the recall by letter on April 1, 2014. The company has not received
reports at this time of any patient incidents related to this issue.
The core wire of the Alligator device is also coated with PTFE. The same
manufacturing process changes to the application of the PTFE coating
that were incorporated into the Pipeline device apply to the Alligator
device. Covidien also submitted to the FDA a Special 510(k) change in
the manufacturing process for the Alligator device.
The Pipeline devie is indicated for the endovascular treatment of
adults (22 years of age and older) with large or giant wide-necked
intracranial aneurysms in the internal carotid artery from the petrous
to the superior hypophyseal segments. The Alligator device is intended
for use in the peripheral and neuro-vasculature for foreign body
Covidien is a global health care leader that understands the challenges
faced by providers and their patients and works to address them with
innovative medical technology solutions and patient care products.
Inspired by patients and caregivers, Covidien's team of dedicated
professionals is privileged to help save and improve lives around the
world. With more than 38,000 employees, Covidien operates in 150-plus
countries and had 2013 revenue of $10.2 billion. To learn more about our
business visit www.covidien.com
or connect with us on Twitter.
COVIDIEN CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Statements contained in this communication that refer to Covidien's
estimated or anticipated future results or other non-historical facts
are forward-looking statements that reflect Covidien's current
perspective of existing trends and information as of the date of this
communication. Forward-looking statements generally will be accompanied
by words such as "anticipate," "believe," "plan," "could," "should,"
"estimate," "expect," "forecast," "outlook," "guidance," "intend,"
"may," "might," "will," "possible," "potential," "predict," "project,"
or other similar words, phrases or expressions. It is important to note
that Covidien's goals and expectations are not predictions of actual
performance. Actual results may differ materially from Covidien's
current expectations depending upon a number of factors affecting
Covidien's business. These factors include, among others, competitive
factors and market conditions in the industry in which Covidien
operates; Covidien's ability to obtain regulatory approval and customer
acceptance of new products, and continued customer acceptance of its
existing products; and the other risks identified in Covidien's periodic
filings including its Annual Report on Form 10-K for the fiscal year
ended September 27, 2013, and from time to time in Covidien's other
investor communications. We caution you that the foregoing list of
important factors is not exclusive. In addition, in light of these risks
and uncertainties, the matters referred to in Covidien's forward-looking
statements may not occur. Covidien undertakes no obligation to publicly
update or revise any forward-looking statement as a result of new
information, future events or otherwise, except as may be required by
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