Medtronics Reports FDA Approval Of Capsurefix Novus MRI Surescane 5076

Medtronic today announced the U.S. Food andDrug Administration (FDA) approval of its CapSureFix Novus(TM) MRI SureScan®5076 Lead for use with magnetic resonance imaging (MRI). The lead is approvedfor MRI scans positioned on any region of the body when paired with aMedtronic dual-chamber MR-conditional pacemaker.The 5076 lead, previously approved for use with Medtronic's non-MR-conditionalpacemakers, has been well-received because of its handling and provenreliability. Since its introduction more than 10 years ago, physicians haveimplanted more than 3 million 5076 leads in patients.^[i]^, [ii]With the new FDA approval, two 5076 MRI leads can now be paired withdual-chamber Medtronic Advisa MRI(TM) or Revo MRI(TM) SureScan® pacemakers,allowing patients with these complete SureScan pacing systems to undergofull-body MRI scans. Medtronic 5076 MRI lead lengths approved for these scansrange in length from 35cm to 85cm. Patients who previously had two 5076 leadsimplanted with non-MRI pacemakers will have the option to receive MRIs ifMR-conditional SureScan pacemakers are implanted when replacement devices areneeded."The 5076 lead has proven to be one of the most reliable pacing leads for morethan a decade, and due to extensive testing, now also can undergo MRI scans,"said Brian Urke, vice president and general manager of the bradycardiabusiness at Medtronic. "This is especially important for patients who needMRIs and received 5076 leads at the time of their initial implants; althoughthey may not have received MR-conditional pacemakers initially, they now havethe option to get a pacemaker approved for MRI when they require a devicechange-out, making the entire system MR-conditional."Medtronic has spent more than 17 years studying the MRI environment, and wasthe first in the industry to introduce a pacemaker system specificallyengineered for this purpose. Since its first MR-conditional pacing system wasapproved in Europe in 2008, Medtronic has continued to design and test itsproducts for safe use during MRI scanning. Advances in computer modeling haveallowed Medtronic to vigorously evaluate the 5076 lead across more than 2million scanning scenarios. ^^[iii] Medtronic also conducted the 5076 MRIClinical Study, a global, multi-center, study to evaluate the safety andeffectiveness of the 5076 lead in the MRI environment.Worldwide, it is estimated that up to 75 percent of patients with implantedcardiac devices are expected to need an MRI scan during the lifetime of theirdevices.^^[iv] MRI is the standard of care in soft tissue imaging, providinginformation not seen with X-ray, ultrasound or CT scan. MRI is thereforecritical for the early detection, diagnosis and treatment of many diseases.Until recently, patients with implanted pacemakers were denied access to MRIprocedures because the interaction can be harmful. ^^[v]^, ^[vi], ^[vii],The 5076 MRI lead is the latest addition to a growing number of Medtronicdevices that are approved for MRI access. These include the Medtronic SureScanpacing systems, the SureScan neurostimulation systems for the management ofchronic pain, and the SynchroMed^® II programmable drug infusion system, whichare available worldwide. Additionally, the Evera MRI(TM) SureScan implantablecardioverter-defibrillator (ICD) system is investigational in the U.S.In collaboration with leading clinicians, researchers and scientistsworldwide, Medtronic offers the broadest range of innovative medicaltechnology for the interventional and surgical treatment of cardiovasculardisease and cardiac arrhythmias. The company strives to offer products andservices that deliver clinical and economic value to healthcare consumers andproviders around the world.