Medtronic Lead Wire | FDA Approval New Defibrillator Lead
Medtronic has received FDA approval for a new defibrillator lead – the Sprint Quattro Secure lead. Last October, a Medtronic recall of its Sprint Fidelis leads was announced following reports of several patients’ deaths due to lead fractures. The following is Medtronic’s announcement of their new defibrillator heart lead.
Medtronic Announces FDA Approval and Market Availability of Sprint Quattro Secure® S Single Coil Defibrillation Lead
MINNEAPOLIS – Dec. 3, 2008 -Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Medtronic Sprint Quattro Secure® S single coil defibrillation lead (Model 6935) for use with implantable defibrillators in patients at risk for dangerous tachyarrhythmias (fast heartbeats) and sudden cardiac arrest. This new defibrillation lead is an addition to the Sprint Quattro® family that is supported by more than seven years of post-market performance data¹. It provides an option for physicians who prefer a specific type of lead for patients with unique anatomies and is designed to help reduce tip pressure. The U.S. approval and market release of this single coil option follows its recent European approval and launch.
The Medtronic Sprint Quattro Secure S lead is designed with an 8.6 French diameter lead body (approximately 2.8 millimeters in diameter). A thin wire inserted into the chambers of the heart through blood vessels, the lead is compatible with any Medtronic implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), which are stopwatch-sized devices that administer electrical shocks or painless pacing therapy to stop dangerous ventricular arrhythmias.
” I prefer a single coil lead for my patients and am looking forward to having this new option available,” said Michael Lincoln, M.D., with Holy Cross Hospital in Silver Spring and NIH Heart Center at Suburban Hospital in Bethesda, Md. “Based on my own clinical experience and the breadth of long-term clinical performance data, I believe the Sprint Quattro family of defibrillation leads is highly reliable.”
“The Sprint Quattro family of defibrillation leads is highly respected in the cardiac community,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “We are pleased the FDA has approved this single coil option, which gives physicians another choice in order to deliver the appropriate treatment to each individual patient.”
In conjunction with this introduction, Medtronic is extending its defibrillation lead warranty to a lifetime limited warranty, which covers all defibrillation leads implanted in the United States on or after Dec. 1, 2008. Under the lifetime warranty, Medtronic 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 United States since 1984.
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U.S. Food & Drug Administration Statement On Medtronic Sprint Fidelis Defibrillator
Medtronic Suspends Sprint Fidelis Defibrillation Leads (PDF)
U.S. FDA Class 1 Recall Report
If you or a loved one have been injured by the Medtronic Sprint Fidelis lead please contact us immediately. You may be entitled to compensation.
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