Axogen Expands RECON Study Of Avance Nerve Graft
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.
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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.
An internal investigation found that the company’s leadership may have directed employees to improperly account for sales-incentive payments. As a result, the company has been unable to file its quarterly report for the first quarter of 2022 with the SEC.
Analysts believe the company’s arrythmia mapping technology could potentially disrupt the electrophysiology mapping market, but are disappointed with Acutus’ growth so far.