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news.St Jude Medical has received the FDA and European CE Mark approvals for the company's IsoFlex Optim pacing lead.
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The IsoFlex Optim lead can be used with pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The small-diameter lead is built on the proven IsoFlex pacing lead platform, and features the company’s exclusive Optim insulation material.
Optim insulation is designed to provide increased durability, and to improve flexibility, handling characteristics and control during implant procedures. With the addition of Optim insulation to IsoFlex leads, all St. Jude Medical pacemaker and ICD leads now are available with Optim insulation.
Eric Fain, president of the St Jude Medical Cardiac Rhythm Management Division, said: “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.”