Starts & Stops: Boston Scientific Launches New Lotus TAVR Trial, Medtronic Starts Study Of SynchroMed II Pain Pump
Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by MedDeviceTracker. This edition covers trial announcements from Jan. 7 through Jan. 27, including announcements from Medtronic, QT Vascular, Boston Scientific, and Shockwave.
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The US FDA approved Boston Scientific's Lotus Edge transcatheter aortic valve for patients who would be at high risk with surgical valve replacement. Unlike competing TAVR systems from Medtronic and Edwards, Lotus Edge can be repositioned or recaptured after it has been deployed.
The study will be expanded by 50 patients, for a total of 220 subjects, based on the recommendation of a statistician who reviewed an interim analysis. RECON is intended to support a Biologic License Application for Avance, a processed human nerve allograft for bridging severed peripheral nerves.
A new cost-effectiveness study shows cancer patients using targeted drug delivery with Medtronic’s SynchroMed II infusion system and conventional medical management incur lower overall health care costs than patients using conventional medical management alone.