APPROVALS ANALYSIS: MR-Compatible CRM Devices Lead Big Cardiovascular Crop
This article was originally published in Clinica
Approvals reported from eight different territories, including three new PMAs and eight PMA supplements, allowed the number of approvals in February to keep pace with January’s count.
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The company recently launched six new implantable high-voltage cardiac rhythm management devices with the thin elliptical BIOshape to minimize the risk of skin erosion around the device pocket. Rivacor and Acticor also feature Biotronik's DX leadless atrial diagnostic technology, and MRI AutoDetect which automatically switches the device to a MR-safe mode when it enters a magnetic resonance imaging environment.
July 2017 brought 26 approvals from outside the United States, including 14 CE marks in Europe and 12 from five other territories. Almost half of the approvals were for cardiovascular devices; the rest came from eight other categories.
The medtech giant says slow sales in its cardiovascular and diabetes businesses while it awaits important product approvals were a drag on its overall revenues during the second fiscal quarter of 2017.