The FDA has approved Medtronic’s Sprint Quattro Secure S single-coil defibrillation lead (Model 6935) for use with implantable defibrillators in patients at risk for dangerous tachyarrhythmias and sudden cardiac arrest.
The new defibrillation lead is an addition to the Sprint Quattro family, and provides an option for physicians who prefer a type of lead for patients with complex anatomies and is designed to help reduce tip pressure. The company said the U.S. approval and market release of the single coil option follows its recent European approval and launch.
The Minneapolis-based Medtronic said that its Sprint Quattro Secure S lead is designed with an 8.6 French diameter lead body (approximately 2.8 mm in diameter). The lead is compatible with Medtronic implantable cardioverter-defibrillators or cardiac resynchronization therapy-defibrillators.
In conjunction with this introduction, Medtronic said it is extending its defibrillation lead warranty to a lifetime limited warranty, which covers all defibrillation leads implanted in the U.S. on or after Dec. 1. Under the lifetime warranty, the company said it will provide a replacement lead at no charge if the lead does not perform according to specification and meets other specified warranty criteria. It also will reimburse patients for certain unreimbursed medical expenses in the amount specified in the warranty. Defibrillation leads implanted before Dec. 1, 2008 are covered by Medtronic’s current five-year limited warranty. Medtronic has offered a lifetime limited warranty on pacing leads in the U.S. since 1984.