Medtronic Announces CE Mark And European Launch of TYRX Absorbable Antibacterial Envelope

Medtronic, Inc. (NYSE: MDT) has received
CE (Conformité Européenne) Mark for the TYRX(TM) Absorbable
Antibacterial Envelope. This innovative mesh envelope covers an
implantable cardiac device to help stabilize the device after
implantation and reduce surgical-site infections.

The efficacy of the previous generation, non-absorbable TYRX(TM)
Antibacterial Envelope* has been shown in three published studies, with
new six-month follow-up data from the CITADEL/CENTURION Study presented
at Cardiostim 2014. Six months following implantation, patients who
received a single- or dual- chamber implantable
cardioverter-defibrillator (ICD) or cardiac resynchronization therapy
(CRT) replacement device with a TYRX Antibacterial Envelope experienced
lower infection rates than a historical cohort of patients who were
implanted without the envelope.

Specifically, infection occurred in 0.2 percent of patients who received
the envelope during an ICD or CRT implant, compared to 1.9 percent of
patients who did not receive the envelope (p rate of device mechanical complications was low (4.0 percent) in
patients who received the envelope.

CITADEL/CENTURION is a multicenter study involving 55 sites in the
United States that prospectively treated more than 1,000 patients
undergoing an ICD or CRT replacement with the TYRX Antibacterial
Envelope; the primary endpoints were major infection (involving any site
other than skin or subcutaneous tissue of the incision or endocarditis)
and device mechanical complication.

"The TYRX envelope seems to offer physicians a simple, yet highly
effective method of reducing surgical-site infections, particularly
among those high-risk patients who are undergoing a repeat procedure,"
said Charles Kennergren, M.D., Ph.D., Sahlgrenska University Hospital,
Gothenburg, Sweden. "We have high expectations for this novel product,
both in terms of reducing infection rates as well as avoiding device
migrations." Dr. Kennergren recently performed the first implant of the
envelope in Europe.

The TYRX Absorbable Antibacterial Envelope, covering a cardiac
implantable electronic device (CIED) such as a pacemaker, ICD or CRT
device, releases rifampin and minocycline to the surgical site to help
prevent infection. The envelope stabilizes the CIED, then dissolves and
is fully absorbed approximately nine weeks after implantation. The TYRX
Absorbable Antibacterial Envelope is currently cleared for use in the
United States and approved in Canada and Israel. Medtronic acquired
U.S.-based TYRX in January 2014.

"While the risk of infection is low for most patients receiving an
implantable device, the TYRX envelope offers an extra layer of
protection," said John Liddicoat, M.D., president of the Cardiac Rhythm
and Heart Failure business and senior vice president of Medtronic. "The
TYRX envelope provides physicians with a proven solution to make
implantable device procedures safer for their patients."

In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of
cardiovascular disease and cardiac arrhythmias.

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