Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - July 26, 2007

St. Jude Medical Receives FDA Clearance for ACross Transseptal Access System

New device increases control and reduces complexity of critical step in accessing the left atrium

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) clearance and a Health Canada License for the ACross(TM) Transseptal Access System, a device that improves control and simplifies the procedure physicians use to access the left atrium during complex cardiac procedures such as atrial fibrillation ablation.

The device is used to reach the left atrium of the heart, which is difficult to access but where some of the most complex arrhythmias (irregular heartbeats) occur.

The device was first used at Southlake Regional Health Centre in Newmarket, Ontario by Atul Verma, M.D., and Yaariv Khaykin, M.D. "The ACross System brings consistency and simplicity to a procedure which can be complex and challenging," said Dr. Khaykin. "While ACross uses techniques and approaches that have been employed by EPs (electrophysiologists) for many years, its enhanced tools simplify the procedure and add safeguards for some of the most critical steps."

The ACross Transseptal Access System consolidates the sheath, dilator and needle into a single interlocking handle for greater control over the system's components and more intuitive positioning within the heart. The device's handle allows the components to fit precisely together, ensuring that the puncture needle is not deployed until the physician is confident in its location, and that it is only advanced a pre-determined distance. Also, the ergonomic design incorporates a directional fin, or ridge, on the handle, so that the physician will intuitively know the orientation of the needle and sheath tip within the heart.

Because there is no direct path to the left atrium to deliver therapy, EPs use a long, curved needle to puncture the septum, or wall, between the left and right atrium and pass a sheath into the left chamber. The process of making this puncture and creating a conduit to the left atrium is called a "transseptal" procedure.

Traditional transseptal tools require clinicians to simultaneously manipulate a separate needle, dilator, and sheath, maintaining precise distances between each component and their angles relative to the patient's anatomy. This complex procedure may often require two or more people to manipulate the various components to prevent potential complications due to inadvertent needle deployment or improper orientation.

The ACross Transseptal System is part of a growing portfolio of access, diagnosis, visualization and therapy products provided by St. Jude Medical to help physicians serve the unmet clinical needs of patients with cardiac arrhythmias.

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

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 Report on Form 10-Q filed on May 9, 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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