Interventional device developer Medtronic announced it has received regulatory approval in Japan to market an implantable cardioverter defibrillator (ICD) that can undergo MRI scans.
Studies have estimated that over half of ICD patients will need an MRI scan within 10 years of receiving the device. But until the availability of MRI-conditional devices, patients with such implants were contraindicated from getting scans.
The company's Evera MRI SureScan ICD makes it possible to scan these patients. Evera MRI is available in single- and dual-chamber models, and it features a contoured shape that fits better inside the body, increasing patient comfort by reducing skin pressure by 30%, according to the company.
The device also includes SmartShock 2.0, a shock reduction algorithm that enables the device to differentiate between dangerous and harmless heart rhythms, as well as OptiVol 2.0, Medtronic's fluid status monitoring and diagnostics tool, which identifies patients at risk of worsening heart failure and atrial fibrillation.
Evera MRI is limited to investigational use in the U.S., according to the company.
