Japanese Approve St. Jude Medical’s Durata Defibrillation Lead


August 7, 2008

August 7, 2008 - St. Jude Medical Inc. today said it received regulatory approval, in addition to reimbursement approval, from the Japanese Ministry of Health, Labour and Welfare (MHLW), for the Durata defibrillation lead, the company’s next-generation high-voltage lead.

The Durata lead incorporates a soft silicone tip with a larger surface area and a slightly curved right ventricle (RV) shock coil intended to enhance ease of use and handling for physicians implanting an ICD (implantable cardioverter defibrillator) system in patients at risk for dangerously fast heart rhythms. The Durata lead also incorporates Optim insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads. The company said Optim insulation blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane to provide increased durability, along with the flexibility and handling characteristics that facilitate device implantation.

The Durata lead is the same size as the company’s Riata ST Optim lead which, at 7 French, is the smallest diameter high-voltage lead on the market. Small diameter leads may be especially helpful for patients with compromised blood flow, a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel.

St. Jude Medical Durata leads feature flatwire technology with complete silicone backfill designed to prevent tissue in-growth; dual, redundant cables designed to increase reliability, so that if one cable is damaged another will provide backup; and single- and dual-coil design with 17 cm and 21 cm shock coil spacing, which gives physicians more options when selecting the most appropriate lead for individual patient anatomy.

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.

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (known as ventricular tachycardia or ventricular fibrillation) by delivering energy to the heart through an insulated wire or lead. Defibrillation leads also have the ability to sense disruptions to a patient's heartbeat, and transmit these impulses back to the ICD to determine whether the potentially life-saving therapy should be delivered.

For more information: www.sjm.com