St Paul, Minnesota - St. Jude Medical Inc.'s polyurethane/silicone leads for pacemakers and other implantable devices have been approved by the US Food and Drug Administration (FDA) and have also gained the European CE Mark. These small-diameter pacing leads use St Jude's IsoFlex pacing lead design, with its Optim insulation material.
Addition of Optim insulation to the IsoFlex leads means that all St Jude Medical pacemaker and implantable cardioverter defibrillator (ICD) leads now are available with this hybrid insulation material, which the company said blends the biostability and flexibility of high-performance silicone rubber with the strength, tear and abrasion resistance of polyurethane.
The PU/silicone combination offers better durability, and flexibility, good handling characteristics and gives control during implant procedures, the company added, in a 14 May statement. The last feature was emphasised by S. Pakarinen, MD, from the Division of Cardiology, Helsinki University Central Hospital in Finland, who has implanted more than 500 leads with Optim insulation: "When I use a lead with Optim insulation …. I know I am providing my patients with a product that is designed to be durable," he said, in the St Jude announcement,
St. Jude Medical is tracking more than 5000 leads with Optim insulation, and said the information gathered over the last two years will be presented at Heart Rhythm 2008, to be held 14-17 May, in San Francisco.
These leads are thin insulated wires implanted in a vein, with a tip attached to the heart tissue, and the other end to the pacemaker or ICD: the wire carries electrical impulses between the device and the heart.