Biotronik said today it won Japanese regulatory clearance for its Itrevia 7 HF-T cardiac resynchronization therapy defibrillator, now approved for full-body MRI-scanning.
With the clearance, physicians in Japan are now cleared to perform MRI scans at 1.5 tesla strength on patients implanted with the Itrevia CRT-D.
“In addition to having indispensable diagnostic information in the field of cerebrovascular treatment and orthopedics, MRI offers extensive diagnostic cardiovascular information. Many CRT-D patients undergo a cardiac MRI before implantation to assess the late gadolinium enhancement. However, until now CMR after CRT-D implantation was not possible, thus no assessment on the presence or absence of any changes could be achieved. Now with the condition change, post-operative cardiac MRI examination has become feasible with the Itrevia 7 HF-T series,” Dr. Seiji Takatsuki of Keio University Hospital said in a press release.
The device was originally launched in Japan in July last year, though without the MR-safe clearance. Biotronik claims the clearance makes it the 1st and only CRT-D in Japan that’s compatible with up to 1.5 tesla MR scanners.
“We’re determined to help our patients live normal lives. Having access to MRI scanning is part of that. Physicians have long asked for MRI access in the cardiac area of device patients and we are answering that call,” Biotronik Japan managing director Jeffrey Annis said in prepared remarks.
Earlier this month, Biotronik said it won CE Mark approval for its Ilivia ICD and CRT-Ds, which alsofeature the company’s ProMRI and MRI AutoDetect technology to make them compatible with magnetic resonance imaging systems.
Biotronik’s MRI AutoDetect feature allows the device to be set to automatically recognize MRIs and switch into MRI mode without having to directly interact with the device before and after the scan, the company said. After the scan, the device is designed to send a report to monitoring physicians outlining the operational switch.
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