Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology FDA

 News Release - May 13, 2008

St. Jude Medical Announces FDA and European CE Mark Approvals of the IsoFlex Optim Pacing Lead

Optim insulation now available in all St. Jude Medical pacemaker and ICD 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 approvals of the IsoFlex® Optim™ pacing lead. The small-diameter lead is built on the proven IsoFlex® pacing lead platform, and features the company’s exclusive Optim® insulation material. With the addition of Optim insulation to IsoFlex leads, all St. Jude Medical pacemaker and ICD leads now are available with Optim insulation.

Optim insulation is a hybrid insulation material that blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane. (Silicone rubber and polyurethane are the standard lead insulation materials.) This combination is designed to provide increased durability, and to improve flexibility, handling characteristics and control during implant procedures.

Currently, St. Jude Medical is tracking more than 5,000 leads with Optim insulation in its OPTIMUM (Optim Lead Insulation Material) registry. Information gathered from this registry over the last two years will be presented at Heart Rhythm 2008, to be held May 14-17, in San Francisco.

“When I use a lead with Optim insulation, I know I am providing my patients with a product that is designed to be durable,” said S. Pakarinen, M.D., from the Division of Cardiology, Helsinki University Central Hospital in Finland, who has implanted more than 500 leads with Optim insulation. “At the same time, I know I will experience excellent handling characteristics that give me more control during the implant procedure.”

In addition to Optim insulation, the IsoFlex Optim lead offers:

  • A thin profile that helps to provide better access to the vein and helps preserve venous space.
  • A steroid-eluting tip, designed to reduce inflammation in the cardiac tissue to promote more stable pacing thresholds (the lowest amount of energy required by the pacemaker to continue pacing the heart).
  • A small tip electrode surface to help provide higher lead impedances, which can reduce energy drain and thereby help devices last longer.
  • Different lead shapes for implantation in the upper or lower chambers of the heart.

"We designed Optim insulation for enhanced reliability, while providing the control, flexibility and handling physicians have told us they want for lead implantation,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “The IsoFlex lead platform has provided sound pacing lead performance for thousands of patients, and the marriage of this lead with Optim insulation gives physicians and patients a powerful tool for pacing therapy.”

The IsoFlex Optim lead can be used with pacemakers, implantable cardioverter defibrillators (ICDs), and Cardiac Resynchronization Therapy (CRT) devices.

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 or ICD. A lead carries electrical impulses from the pacemaker or ICD to the heart and transmits information from the heart back to the implanted device.

Heart Rhythm 2008 takes place May 14-17 at the Moscone Convention Center in San Francisco. The meeting is the most comprehensive educational event on heart rhythm disorders, offering 250 educational opportunities in multiple formats. The world’s most renowned scientists and physicians will present a wide range of heart rhythm topics including advances in statins, Cardiac Resynchronization Therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. 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 Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K filed on February 27, 2008. 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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