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St Jude pacing lead receives FDA and CE MArk approval

St Jude Medical : 14 May, 2008  (New Product)
St Jude Medical has received US 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.) The 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 to 17, in San Francisco, USA.

'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, MD, 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, MD, 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.

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