Medtronic Receives CE Mark for Attain Stability(TM) Quad MRI SureScan(TM) Active-Fixation Heart Lead

ID: 1518242
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(Thomson Reuters ONE) -


Clinical Trial Also Underway in U.S., Canada and Other Geographies

DUBLIN - August 21, 2017 - Medtronic plc (NYSE: MDT) announced it has received
CE (Conformité Européene) Mark for the Attain Stability(TM) Quad MRI
SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac
resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the
Attain Stability Quad lead features novel, active-fixation technology that is
designed for precise lead placement and stability. In the United States, the
Attain Stability Quad lead is under evaluation in a clinical trial and is not
approved for sale.

The company has undertaken a limited European launch, and first commercial
implants recently were performed at Haukeland University Hospital, Bergen,
Norway.

"This new lead provides another option for left ventricular lead placement that
can meet the needs of patients with various anatomies," said Prof. Svein
Faerestrand, Haukeland University Hospital. "We now have the ability to place
the lead where we want within the vessel."

CRT is a treatment for heart failure in which an implantable device sends low
levels of energy through thin wires, called leads, to stimulate the heart muscle
and improve the heart''s pumping efficiency. The Attain Stability Quad lead,
which is approved in CE Marked geographies for 3 Tesla (T) and 1.5T magnetic
resonance imaging (MRI) scans, features a side-helix designed to be fixated
precisely in veins of various sizes. Four electrodes (quadripolar technology)
allow physicians flexibility in finding the optimal location for stimulating the
heart.

Medtronic also has initiated a global, prospective, non-randomized, multicenter
clinical study to evaluate the safety and effectiveness of the lead in heart
failure patients. The study will enroll up to 471 patients across 56 sites in


the United States, Canada, Europe, Hong Kong and Malaysia. The primary efficacy
endpoint will evaluate the number of patients that have appropriate pacing
capture thresholds in at least two programming configurations, and the primary
safety endpoint is lead-related complication-free rate at six months. Co-
principal investigators are Kevin Jackson, M.D., heart rhythm specialist at Duke
Raleigh Hospital, and assistant professor of medicine at Duke University, and
George Crossley, III, M.D., associate professor of medicine and
electrophysiologist at Vanderbilt Heart and Vascular Institute. Toshimasa Okabe,
M.D., recently performed the first implant in the clinical trial at Ross Heart
Hospital of The Ohio State University Wexner Medical Center.

"LV lead positioning and stability remain a challenge for physicians," said Dr.
Jackson. "Acute and chronic lead dislodgement are still concerns. This lead''s
active-fixation mechanism gives us another option to get to the desired pacing
location, and stay there."

"We look forward to obtaining results from the Attain Stability Quad clinical
study to support approvals in new geographies and reach more patients," said
Kweli P. Thompson, M.D., M.P.H., vice president and general manager of the
Cardiac Resynchronization Therapy business, part of the Cardiac Rhythm and Heart
Failure division at Medtronic. "Medtronic is committed to helping physicians
treat patients with heart failure by pioneering advancements in CRT, and
creating therapies that provide more personalized treatment."

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. The company strives to offer products and services of the highest
quality that deliver clinical and economic value to healthcare consumers and
providers around the world.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among
the world''s largest medical technology, services and solutions companies -
alleviating pain, restoring health and extending life for millions of people
around the world. Medtronic employs more than 91,000 people worldwide, serving
physicians, hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to take
healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic''s periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
results.

-end-


Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492

Ryan Weispfenning
Investor Relations
+1-763-505-4626



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Medtronic plc via GlobeNewswire






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Date: 08/21/2017 - 12:00
Language: English
News-ID 1518242
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