Global Approvals Snapshot: November 2019

02 Dec 2019

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.

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...