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Global Approvals Snapshot: November 2019

 
• By Reed Miller

November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.

Approved

The US Food and Drug Administration approved five original PMAs in November.

The agency approved Axonics Modulation Technologies Inc.’s r-SNM rechargeable sacral neuromodulation system for treating overactive bladder and urinary retention...

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