Medtronic launches Advisa DR MRI SureScan pacing system after FDA clearance
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By: Katie Bell
Ref: NASDAQ, FinanzNachrichten, Yahoo!Finance
Published: 02/13/2013
Medtronic on Wednesday announced the FDA approval and US launch of its Advisa DR MRI SureScan pacing system, the company's second-generation MR-Conditional pacemaker. Medtronic noted that the system is the first to combine the most advanced pacing technology with proven MRI access.
The device maker said the pacing system was specifically tested and approved for use as labelled with MRI scanners in the US. The company noted that in the Advisa MRI Clinical Trial, none of the 156 patients scanned showed any MRI-related complications.
Medtronic's system includes an Advisa MRI device and two CapSureFix MRI SureScan leads, and also features the Managed Ventricular Pacing algorithm to reduce unnecessary ventricular pacing. Previously, the company's first-generation Revo MRI SureScan pacing system, which gained FDA clearance in 2011, was the only MR-Conditional pacemaker on the market in the US.
The device maker said the pacing system was specifically tested and approved for use as labelled with MRI scanners in the US. The company noted that in the Advisa MRI Clinical Trial, none of the 156 patients scanned showed any MRI-related complications.
Medtronic's system includes an Advisa MRI device and two CapSureFix MRI SureScan leads, and also features the Managed Ventricular Pacing algorithm to reduce unnecessary ventricular pacing. Previously, the company's first-generation Revo MRI SureScan pacing system, which gained FDA clearance in 2011, was the only MR-Conditional pacemaker on the market in the US.