A blog about what is new (and old) in the world of active implantable medical devices 

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Home Technologies Archive for category "MRI-safe"
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Sorin Announces CE Mark and Implant of its MRI-Compatible Kora 100 Pacemaker with Automatic MRI Mode

Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system. According to the press release: KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population

 
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AAMI Technical Information Report Gives Guidance to AIMD Designers Regarding MRI Compatibility

A new technical information report (TIR) provides guidance to design active implantable medical device manufacturers for use in patients who may need magnetic resonance imaging (MRI) scans. ANSI/AAMI/ISO TIR10974:2012, “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device” was adopted and published by AAMI is meant to inform

 
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Medtronic SureScan Neurostimulators Cleared by FDA for Full-Body MRI

Following Medtronic’s announcement in February of this year that it had introduced in Europe the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions, the Company announced today that FDA has approved the

 
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Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

Biotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD. Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector

 
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Medtronic Introduces First Neuromodulation Systems Compatible with Full-Body MRI

Medtronic has introduced in Europe the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions.  Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or

 
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St. Jude Starts Trial of Accent MRI Pacemaker and Tendril MRI Lead

Today St. Jude announced the first implant in its Accent MRI(R) Pacemaker and Tendril MRI(R) Lead IDE Study (MRI Study). The ultimate goal of the study is to determine if patients with these devices can safely undergo full-body, high resolution Magnetic Resonance Imaging (MRI) scans to better accommodate their medical needs. The investigational Accent MRI

 
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Medtronic Receives CE Mark for CapSure Sense MRI™ SureScan® Pacing Leads

Medtronic today announced the receipt of CE Mark and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during MRI procedures.  The newly approved leads are the smallest MR–Conditional leads available in the world with a 5.3 French isodiametric lead body.  The new leads are passive-fixation leads.  Previously approved Medtronic MR–Conditional leads

 
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Development and Test of MRI-Safe Implantable Devices

The November issue of Evaluation Engineering carried an article by Tom Lecklider on the amount of work invested by Medtronic to develop and test the Revo MRI pacemaker system.  The article is available on-line at Evaluation Engineering (Click here for direct link to the November 2011 issue).

 
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