Global Approvals Snapshot: November 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.
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A device newly approved by the US FDA will allow physicians to insert ear tubes to treat recurrent ear infections in the office, eliminating the risks of general anesthesia. The Tubes Under Local Anesthesia (Tula) System was reviewed via the agency’s breakthrough device pathway.
Registry data from France shows transcatheter aortic valve replacement patients have better outcomes with Edwards’ Sapien balloon-expandable valves than with Medtronic’s CoreValve self-expanding valves.