FDA Approves Medtronic’s Visia AF Device
Medtronic has scored FDA approval for its Visia AF MRI SureScan and AF implantable cardioverter defibrillators.
The atrial fibrillation (AF) systems are designed to treat previously undiagnosed and/or aymptomatic AF, monitor recurrent AF and treat “life-threatening” rhythms located in the lower chambers.
The devices feature an algorithm that pinpoints AF episodes and captures AF frequency. A product launch is expected in early summer.
Siemens MRI Applications Cleared
The FDA has granted clearance to Siemens Healthcare’s two magnetic resonance imaging applications, Simultaneous Multi-Slice (SMS) and GOBrain, which are intended to decrease time required for MRIs of the brain.
The SMS application works to reduce acquisition times and the GOBrain app improves patient throughput, both of which can lead to a reduction in costs per scan, according to the company.
Brain scans account for roughly 1 out of 4 MRI examinations.
FDA Clears Medtronic’s StrataMR Valves
Medtronic has earned FDA clearance for its StrataMR valves and shunts, the latest addition to the company’s suite of Strata adjustable valve systems, designed to treat hydrocephalus and cerebrospinal fluid disorders.
The move broadens Medtronic’s line of MRI-compliant systems including, pacemakers, ICDs, deep-brain stimulation systems and spinal cord stimulators.
The system is designed to resist performance level setting changes during MRI exposure and will be available in the “coming months.”
Boston Scientific’s Ablation Catheters Approved
The FDA has approved Boston Scientific’s IntellaNav XP and MiFi XP navigation-enabled ablation catheters for the treatment of Type I atrial flutter, the device giant announced May 3.
Both devices contain sensors which are able to magnetically track the location of the catheter.
In addition, the catheters can be used in conjunction with the company’s Rhythmia Mapping system — which can produce three-dimensional images of any heart chamber — to improve cardiac ablation procedures and to diagnose arrhythmias, according to the company.
Biotronik’s Iperia Defibrillator Approved
The FDA has granted approval to Biotronik’s Iperia ProMRI HF-T — a cardiac resynchronization defibrillator designed for patients with heart failure, the company announced Tuesday.
The device gives patients with heart failure access to MRI scans and features daily automatic transmission and closed loop stimulation.
The approval expands the company’s existing portfolio of MR conditional ICDs.