St. Jude Medical Announces FDA Approval of FlexAbility Ablation Catheter

Approval introduces the first and only irrigated ablation catheter with a flexible tip in the U.S., adding to the company’s unrivaled ablation technology portfolio

Image of the flexible tip of the FlexAbility ablation catheter. The tip was developed to conform better to cardiac anatomy, allowing for effective lesion formation. (Photo: St. Jude Medical, Inc.)

ST. PAUL, Minn.--()--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of the FlexAbility™ Ablation Catheter, a new ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias. Designed with feedback from leaders in the electrophysiology community, the FlexAbility catheter combines a bendable irrigated catheter tip with an advanced handle and next generation shaft design. The unique flexible tip was developed to conform better to the cardiac anatomy, allowing for effective lesion formation. This added flexibility, in addition to the catheter’s ability to maneuver easily and reliably in challenging cases, was designed to enhance the quality of care for patients around the world who require ablation procedures.

“The FlexAbility catheter is the only ablation catheter with a flexible tip available to electrophysiologists in the United States today,” said Dr. Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute. “For the past several years we’ve been looking for a catheter that provided a gentler, more optimal approach to ablation. The FlexAbility catheter addresses this need and provides me with another safe treatment option for my patients.”

Ablation catheters, such as the pioneering FlexAbility catheter, are thin, flexible wires used to help treat irregular heartbeats that impair the heart’s ability to effectively pump blood throughout the body. In the U.S., an estimated 10.4 million people have some type of cardiac arrhythmia. The FlexAbility catheter features an innovative handle and shaft combination that allows for improved maneuverability, enabling electrophysiologists to reach challenging anatomic locations within their patients’ hearts. This new technology was also designed to provide optimal irrigation flow over the entire tip for improved cooling, potentially reducing risk factors associated with the delivery of therapy.

“As we developed the FlexAbility ablation catheter, we worked with leading electrophysiologists to ensure this ablation technology would advance the treatment of complex arrhythmias,” said Srijoy Mahapatra, M.D., vice president of clinical, medical and scientific affairs at St. Jude Medical. “Our development goal was to leverage the unique flexible tip and combine it with optimal performance and maneuverability, especially during the most challenging clinical cases. Physician experience within Europe has confirmed that we have met this goal and the FlexAbility catheter is well positioned to become an important ablation technology for electrophysiologists around the world.”

The FDA approval of the FlexAbility catheter, which received CE Mark in Europe last year, further strengthens St. Jude Medical’s fast-growing ablation technology portfolio and expands the ability of physicians to treat patients battling abnormal heart rhythms. The TactiCath™ Quartz contact-force sensing irrigated ablation catheter, approved and commercially available in Europe since 2012 and the U.S. since 2014, pioneered the ability to give physicians a real-time, objective measure of the force applied to the heart wall during a cardiac ablation procedure to treat paroxysmal atrial fibrillation (AF). The introduction of the FlexAbility catheter in the U.S. provides physicians with a best in class catheter for all their non-contact force cases. Combined, the technology offers physicians two new unique catheters that offer innovative solutions designed to improve outcomes, efficiency and productivity in electrophysiology labs worldwide.

About St. Jude Medical’s Arrhythmia Business
St. Jude Medical's arrhythmia business, based in St. Paul, Minn., is one of the fastest growing divisions within St. Jude Medical. A leader in collaborating with world-renowned electrophysiologists, clinicians and hospital administrators, St. Jude Medical develops safe and cost-effective treatment solutions for patients in need of advanced ablation therapies. The FlexAbility ablation catheter was developed to be used seamlessly with St. Jude Medical’s existing portfolio of electrophysiology products, including the EnSite™ Velocity™ System, the Ampere™ RF Generator and the Agilis™ NxT Steerable Introducer.

For more information about St. Jude Medical’s focus on arrhythmia management, visit SJM newsroom/arrhythmias-stroke-prevention.

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 September 27, 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.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Justin Paquette, 651-756-6293
jpaquette@sjm.com

Release Summary

The FDA has approved the St. Jude Medical FlexAbility ablation catheter. FlexAbility is the only ablation catheter with a flexible tip available to electrophysiologists in the United States today.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Justin Paquette, 651-756-6293
jpaquette@sjm.com