Healthcare Industry News:  lead delivery system 

Devices Cardiology FDA

 News Release - April 18, 2006

FDA Approves St. Jude Medical's New Heart Failure Lead Delivery System

ST. PAUL, Minn.--(HSMN NewsFeed)--April 18, 2006--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of the Cardiac Positioning System (CPS(TM)) family of lead delivery tools for heart failure.

The Cardiac Positioning System is designed to give physicians greater control and precision when implanting cardiac resynchronization therapy (CRT) devices (defibrillators or pacemakers) in heart failure patients. The system especially helps physicians navigate the left side of the heart, which is usually the most challenging and is critical in treating patients suffering the debilitating effects of heart failure.

Studies have shown that cardiac resynchronization therapy can improve quality of life for heart failure patients by reducing symptoms like fatigue and shortness of breath. Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood to the body. About 5 million Americans suffer from heart failure, with approximately 550,000 new cases diagnosed each year. The economic burden of heart failure is estimated at $40 billion per year.(a)

"The Cardiac Positioning System enables faster, easier procedures with clearly visible three-dimensional markers to guide implantation. It is the easiest to remove of any braided catheter I've used," said Thomas A. Mattioni, M.D., of Arizona Arrhythmia Consultants in Phoenix, Ariz.

Some physicians prefer braided catheters over non-braided catheters because they resist kinking, which may allow the physician to complete the procedure sooner and reduce the risks to patients of a longer surgery.

"The CPS Luminary catheter is the first catheter that allows physicians to cannulate the coronary sinus and subselect branch veins with one device, which makes the procedure less complex," added Jeffrey S. Goodman, M.D., of Cedars-Sinai Medical Center in Los Angeles, Calif.

All of the Cardiac Positioning System's new components were designed with feedback received from physicians who routinely perform these implant procedures. The new components include:
  • -- An outer guide catheter with three-dimensional markers designed to help physicians better visualize the anatomy so lead placement can be more accurate.
  • -- An inner guide catheter designed to form a telescope so other medical instruments critical to the success of the procedure can reach the desired location.
  • -- A bideflectable catheter with one-hand steering designed to give physicians greater control to more reliably reach the desired site, so the patient can receive maximum benefit from cardiac resynchronization therapy.
  • -- A wire control catheter designed with a deflectable tip and torqueable shaft to help physicians make turns in complex patient anatomies.
"Our Cardiac Positioning System is the result of listening to what physicians say they need most for successful CRT implants," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "The latest technological advances designed to facilitate cardiac resynchronization therapy are now available in one seamlessly integrated system of delivery tools."

St. Jude Medical's Cardiac Positioning System lead delivery tools for heart failure include:
  • -- The CPS Direct(TM) SL braided outer guide catheter with SiteMark(TM) three-dimensional markers.
  • -- The CPS Aim(TM) inner catheters.
  • -- The CPS Luminary(TM) bideflectable catheter with lumen.
  • -- The CPS Venture(TM) wire control catheter.
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., the Company employs approximately 10,000 people worldwide. For more information, please visit www.sjm.com.

Forward-Looking Statement

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 anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success.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 Cautionary Statements described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21).The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

(a)O'Connell, JB. The Economic Burden of Heart Failure. Clinical Cardiology 2000, 23 (Supplement III) III-6-III-103.


Source: St. Jude Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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