Healthcare Industry News: pacing lead
News Release - November 28, 2006
St. Jude Medical Announces FDA Approval of Optim Lead Insulation for Cardiac Rhythm Management Therapy
ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of an innovative insulation material for cardiac leads used with pacemakers and implantable cardioverter defibrillators (ICDs). Optim(TM) lead insulation is the first silicone-polyurethane co-polymer material created specifically for cardiac lead use.The new Optim insulation is designed for long-term reliability, while providing physicians with better flexibility and handling to facilitate device implantation.
Optim insulation is a new hybrid insulation material, blending the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane. St. Jude Medical is introducing Optim lead insulation on two of its newest leads, the Riata® ST Optim ICD lead and the Tendril® ST Optim pacing lead.
"This new lead insulation blends the best characteristics of polyurethane and silicone into an innovative material that handles well for me in surgery and provides outstanding durability for my patients," said Steven Kutalek, M.D., Drexel University College of Medicine, Philadelphia, Pa.
A lead is a thin insulated wire that is placed through the vein as part of a pacemaker or ICD implantation procedure. Its tip is attached to the heart tissue, and its other end connects to the pacemaker. A lead carries electrical impulses from the pacemaker or ICD to the heart and transmits information from the heart back to the implanted device.
"This pioneering lead materials technology will provide significant benefits to patients and physicians as cardiac rhythm management therapy evolves," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "We are committed to developing innovative products that ease implantation, enhance safety and increase therapeutic benefits for the patient."
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 11,000 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, 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 those described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Reports on Form 10-Q filed on August 7, 2006 (see Item 1A on page 32) and November 7, 2006 (see pages 31-32). 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
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
