Healthcare Industry News: Steerable Introducer
News Release - May 17, 2006
St. Jude Medical Announces FDA Approval, FDA Clearance and European CE Mark of New Electrophysiology ProductsHeart Rhythm Society Meeting to Showcase Strength and Breadth of Product Offering
ST. PAUL, Minn.--(HSMN NewsFeed)--May 17, 2006--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of its Safire(TM) Ablation Catheter, and FDA clearance and European CE Mark for its Inquiry(TM) Optima(TM) PLUS Steerable Diagnostic Catheter.
St. Jude Medical made the announcement at the Heart Rhythm Society's 27th Annual Scientific Sessions in Boston, where these products will be featured for the first time.
The Safire catheter, featuring the new ComfortGrip(TM) handle, can be easily integrated into any existing radiofrequency (RF) generators, and gives physicians improved comfort and control during electrophysiology (EP) procedures. "The catheter exceeded the performance expectation I had," said Robert Schweikert, M.D., of the Cleveland Clinic. "The catheter did a great job reaching its position and then remaining stable once it was there. We used the Safire ablation catheter on a somewhat difficult case and at a challenging position, but the catheter performed quite well and we achieved an excellent outcome."
The Optima PLUS helps physicians map the heart's atria with a 24-electrode catheter that allows physicians to collect more diagnostic data, more quickly when used with St. Jude Medical's newly approved EnSite® System Version 6 software. Using this 3-D imaging technology, the physician will "see" the catheter's position inside the heart. Four electrodes on the 180-degree deflectable shaft display the loop and shaft planes of motion simultaneously in this advanced mapping system.
In addition to Safire and Optima PLUS, St. Jude Medical will showcase a portfolio of catheter-based and surgical ablation products at Heart Rhythm 2006. These new technologies include:
-- The EnSite System Version 6 software, which received FDA clearance earlier in May. The EnSite System is designed to provide highly detailed, three-dimensional (3-D) cardiac models at the time of an EP procedure. Physicians create the 3-D model in small sections that join together automatically, resulting in a cardiac model that shows the openings, ridges and curves in the heart. The models are then used by physicians to collect information about the heart's electrical activity and assist them in diagnosing and treating many arrhythmias, including atrial fibrillation.
EnSite System users at hospitals worldwide will also now have the option to connect to a technical support team that can resolve issues in real time via a secure, broadband Internet connection with EnSite Connect(TM) Remote Support. This is the industry's first remote technical support for a cardiac mapping system.
-- The Agilis(TM) NxT Steerable Introducer, which is available in Europe, reduces the puncture size required when physicians access the left side of the heart, yet maintains a larger inside diameter to help physicians deliver a wide variety of catheters.
"The Heart Rhythm Society meeting is an important opportunity for us to collaborate with clinicians from around the world on the latest techniques for treatment of complex arrhythmias such as atrial fibrillation," said Jane J. Song, president of St. Jude Medical's Atrial Fibrillation Division. "St. Jude Medical is dedicated to leading initiatives to help bring about a cure for an increasing number of patients with Atrial Fibrillation, including developing new technologies, procedures and clinical studies."
At Heart Rhythm 2006, St. Jude Medical will feature in-booth presentations by physicians who will relate their experiences with the EnSite System, Agilis Steerable Introducer and building a successful AF treatment program. St. Jude Medical also will sponsor two symposia:
-- "Raising the Bar by Hybrid Substrate Modification," moderated by electrophysiologists Andrea Natale, M.D., and David J. Wilber, M.D., on Wednesday, May 17.
-- "Frontiers in the Treatment of Atrial Fibrillation," hosted by Douglas L. Packer, M.D., and Shih-Ann Chen, M.D., on Thursday, May 18.
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 10,000 people worldwide. For more information, please visit www.sjm.com.
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 success, regulatory approvals, anticipated future product launches, 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 the risk factors described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and the cautionary statements described in the Company's Quarterly Report on Form 10-Q filed on May 9, 2006 (see pages 29-30). 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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