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Medtronic PLC

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Latest From Medtronic PLC

Brazil Simplifies Class I Approvals To Focus On Higher-Risk Products

Brazil has passed legislation enabling class I (lowest risk) devices and diagnostics to gain market approval through a notification pathway rather than under the current review-based registration system. The move is essentially intended to help regulatory agency Anvisa refocus its efforts toward the higher-risk arena.

Brazil Medical Device

Results Recap: CRT In DC Features New Biotronik Stent Data, Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal Denervation

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering March 1 to March 7, includes results of late-breaking trials presented at the 2019 Cardiovascular Research Technologies (CRT) conference in Washington, DC, including new data supporting Biotronik’s biodegradable polymer sirolimus-eluting stent and the company’s resorbable magnesium stent, results of the LRT trial of transcatheter aortic valves in low-risk patients, plus promising clinical data supporting Ablative System’s alcohol renal-denervation system.

Tracking Trials Clinical Trials

Senseonics Names Francine Kaufman Chief Medical Officer

Senseonics Holdings Inc. has appointed former Medtronic exec Francine Kaufman chief medical officer, effective immediately.

Commercial Appointments

Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive

Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.

Safety Research & Development
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