St. Jude Medical Announces CE Mark Approval and First Use of the FlexAbility Ablation Catheter

  St. Jude Medical Announces CE Mark Approval and First Use of the FlexAbility
  Ablation Catheter

European approval of next-generation ablation catheter further strengthens St.
Jude Medical’s fast-growing ablation technology portfolio

Business Wire

ST. PAUL, Minn. -- July 22, 2014

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today
announced CE Mark approval and first use of the FlexAbility™ Ablation
Catheter, a novel ablation technology used by electrophysiologists for the
treatment of cardiac arrhythmias. Designed with feedback from physician
thought-leaders around the world, the FlexAbility catheter combines a unique,
irrigated flexible catheter tip with a state-of-the-art handle and catheter
design. The next-generation flexible tip technology was designed to reduce
complications associated with ablation procedures through its ability to bend
and conform to the cardiac anatomy, decreasing the amount of pressure
distributed to a patient’s heart wall while simultaneously increasing the
stability of therapy delivery.

European approval of FlexAbility ablation catheter further strengthens St.
Jude Medical's fast-growi ...

European approval of FlexAbility ablation catheter further strengthens St.
Jude Medical's fast-growing ablation technology portfolio (Photo: Business
Wire)

“The goal of the FlexAbility catheter was to bring the most advanced irrigated
ablation solution to the electrophysiology market,” said Eric S. Fain, M.D.,
group president at St. Jude Medical. “Because we worked with industry thought
leaders throughout the development of this technology, we are confident that
its completely redesigned handle and shaft, along with its unique flexible
tip, will become a leading ablation technology that addresses the broad needs
of electrophysiologists across the wide spectrum of patient anatomies.”

Ablation catheters, such as the FlexAbility irrigated ablation catheter, are
thin, flexible wires used to help treat irregular heartbeats that impair the
heart's ability to effectively pump blood throughout the body. Worldwide, an
estimated 34 million individuals have atrial fibrillation (AF), the most
common type of arrhythmia. The FlexAbility catheter features an innovative
handle and shaft that allows for improved maneuverability, enabling
electrophysiologists to reach challenging anatomic locations within their
patients. The technology was designed to provide optimal irrigation flow over
the entire tip for improved cooling, reducing risk factors associated with the
delivery of therapy. The first cases that used the FlexAbility catheter
post-approval took place at IdealMed Unidade Hospitalar de Coimbra in Coimbra,
Portugal by Dr. Andrea Natale and at the Hôpital Haut-Lévèque in Bordeaux,
France by Dr. Nicolas Derval.

“The FlexAbility catheter brings technical and functional advancements to the
electrophysiology lab through its unique catheter tip and excellent handling
capabilities,” said Dr. Natale. “The catheter tip allows for effective lesion
formation with potentially fewer risks, representing an important option for
electrophysiologists that are looking to broaden their ability to treat
arrhythmias with increased confidence.”

Data that are produced by the FlexAbility ablation catheter are displayed on
the EnSite™ Velocity™ System, a cardiac mapping and navigation system. Once
FlexAbility catheters are inserted in the cardiac chamber the EnSite system
records electrical information from the heart and displays it in a
three-dimensional anatomical model. The highly detailed anatomical models, or
maps, enable physicians to diagnose and guide treatment for abnormal heart
rhythms.

The approval of the FlexAbility catheter further strengthens St. Jude
Medical’s fast-growing ablation technology portfolio, which also includes the
TactiCath™ contact-force sensing irrigated ablation catheter. Approved and
commercially available in Europe since 2012, the TactiCath catheter is
designed to give physicians a real-time, objective measure of the force
applied to the heart wall during a cardiac ablation procedure. The TactiCath
and FlexAbility ablation catheters are investigational devices in the United
States.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world’s most expensive epidemic
diseases. The company does this by developing cost-effective medical
technologies that save and improve lives of patients around the world.
Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical
focus areas that include cardiac rhythm management, atrial fibrillation,
cardiovascular and neuromodulation. For more information, please visit sjm.com
or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. Such forward-looking statements include the expectations, plans
and prospects for the Company, including potential clinical successes,
anticipated regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made by the
Company are based upon management’s current expectations and are subject to
certain risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks
and uncertainties include market conditions and other factors beyond the
Company’s control and the risk factors and other cautionary statements
described in the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the Company’s Annual
Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly
Report on Form 10-Q for the fiscal quarter ended March 29, 2014. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.

Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20140722005854/en/

Multimedia
Available:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50909366&lang=en

Contact:

St. Jude Medical, Inc.
Investor Relations
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations
Kate Stoltenberg, 651-756-3388
kstoltenberg@sjm.com
 
Press spacebar to pause and continue. Press esc to stop.