FDA approves Medtronic’s MR-conditional cardiac defibrillators

7 February 2016 (Last Updated February 7th, 2016 18:30)

The US Food and Drug Administration (FDA) has granted approval for Irish firm Medtronic's magnetic resonance imaging (MRI) conditional cardiac resynchronisation therapy defibrillators (CRT-Ds) to treat heart failure.

amplia

The US Food and Drug Administration (FDA) has granted approval for Irish firm Medtronic's magnetic resonance imaging (MRI) conditional cardiac resynchronisation therapy defibrillators (CRT-Ds) to treat heart failure.

The approved CRT-Ds, Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems are designed to perform MRI scans on any part of the body without positioning restrictions.

According to the company, both CRT-D systems will be commercially available in the coming months and they will help patients treat their heart failure, as well as and reduce their risk of sudden cardiac arrest.

Medtronic cardiac rhythm and heart failure division medical director David Steinhaus said: "With FDA approval of Amplia MRI and Compia MRI, Medtronic continues to lead the market in MR-conditional implantable cardiac devices, bringing greater access to patients that need this vital diagnostic test to identify other potential life-threatening diseases.

"Medtronic is committed to continuing to develop innovative technologies that offer physicians a wide range of technology options to help them improve outcomes for heart failure patients."

"Both devices feature quadripolar technology and provide multiple options to physicians for treatment of heart failure."

Both devices feature quadripolar technology and provide multiple options to physicians for treatment of heart failure by optimising CRT delivery.

Amplia MRI device features the AdaptivCRT algorithm, which is said to reduce patient's odds of a heart failure hospital readmission by 59% compared to echo-optimised CRT.

The devices can also be paired with Attain Perfoma MRI SureScan Quadripolar leads, including Dual Cant MRI SureScan Model 4298, Straight MRI SureScan Model 4398 and S MRI SureScan Model 4598.

With 16 pacing configurations and shorter spacing between the two centre electrodes, these quadripolar leads were shown to reduce the incidence of phrenic nerve stimulation (PNS).

The company received FDA approval for MR-conditional pacemakers in 2011 and implantable cardioverter defibrillators (ICDs) in 2015.


Image: Amplia MRI cardiac resynchronisation therapy-defibrillator. Photo: courtesy of Medtronic plc.