Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA Regulatory

 News Release - January 22, 2008

St. Jude Medical Announces FDA and European CE Mark Approval of the QuickFlex Family of Leads

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approval of the QuickFlex™ family of left-heart leads to treat heart failure patients.

The QuickFlex leads, used in CRT (cardiac resynchronization therapy), feature shorter tip and ring electrodes (used to conduct energy), reducing the length of the lead’s rigid portions. The concept behind the shorter electrodes is that it may help the lead through bends in the heart’s venous system that characterize the left side of the heart. This could enable physicians to better maneuver the lead to the optimal position for therapy.

“The QuickFlex lead is flexible and maneuverable,” said John Rogers, M.D., from Scripps Clinic in La Jolla, Calif. “When working with this lead, I am able to smoothly route it through the venous system to my target location, even through difficult anatomy.”

The QuickFlex lead models also include an S-shaped curve that helps provide stability inside the vein once the lead is placed in the desired location inside the heart. The QuickFlex lead models are available with two different sized S-curves, offering physicians options for patients with varying venous anatomies. The smaller S-shaped curve was evaluated in the company’s 1056T QuickSite® lead clinical study and demonstrated a high implant success rate and low dislodgement rate.

The QuickFlex lead joins St. Jude Medical’s Promote™ RF CRT-D (cardiac resynchronization defibrillator), which was launched in November 2007 to treat patients with heart failure using wireless radiofrequency (RF) telemetry, enabling secure, remote communication between the implanted device and the programmer in a clinician's office or hospital. Promote also allows physicians to electronically reconfigure left-ventricular (LV) leads—such as the QuickFlex lead—to help optimize the pacing performance of the device without the need to physically reposition the lead.

“For heart failure patients to receive effective CRT therapy, physicians must be able to effectively navigate the LV lead through a venous system that often twists and turns, in many cases severely, to deliver the electrodes to the best location for stimulation,” said Eric S. Fain, president of St. Jude Medical’s Cardiac Rhythm Management Division. “The QuickFlex lead offers physicians a good balance of flexibility and stability for effective lead placement.”

Delivered by an ICD or a pacemaker, CRT resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. About 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed each year.

Cardiac leads are used to connect a CRT device to a patient's heart. The lead senses when the heart is functioning normally and sends that information back to the implanted device. When needed, the lead also delivers an electrical pacing pulse from the device to stimulate the heart.

The QuickFlex leads are designed for use with St. Jude Medical's heart failure devices, including the Promote, Epic® II HF and Atlas® II HF families of CRT-Ds (CRT defibrillators), and the Frontier® II CRT-P, the world's smallest and longest-lasting CRT pacemaker.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.sjm.com.

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 Company’s Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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