Medtronic Announces U.S. Market Releas, FDA Approval of Pacing Lead Mar 29, 2004

Printable format  Email this Article  Search

The U.S. Food and Drug Administration (U.S. FDA) has approved the market introduction and device itself of Medtronic Inc.'s (Minneapolis, MN, U.S.) second version of its pacing lead. Medtronic is a medical technology company and makes medical devices.

Pacing leads are insulated wires that carry precisely timed electrical impulses from an implanted pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy system to the inner heart wall to adapt a patient's heartbeat to the needs of his or her circulatory system.

The new CapSureFix(R) Novus Model 4076 lead is a polyurethane-insulated version of the CapSureFix Novus Model 5076, which has a silicone outer insulation and was introduced in the United States in 2000. Both are reportedly slender, active-fixation leads designed to be firmly anchored in specific locations of the heart wall for the treatment of bradycardia, tachycardia, and atrial fibrillation. The Model 4076 is slightly thinner than the 5076 (5.7 French vs. 6.1 French). Both use silicone to insulate inner conduction materials, both elute a steroid to reduce pacing thresholds, and both offer 10-mm tip-to-ring spacing. The newer model incorporates titanium nitride-coated electrodes.

Back to Daily News