In Brief: Spectranetics
This article was originally published in The Gray Sheet
Executive Summary
Spectranetics: Commences U.S. clinical trials the week of Nov. 6 of a "laser assisted pacemaker lead removal device." The firm says its "laser sheath" device is intended "to thread over an implanted pacing lead and ablate through scar tissue" to aid in the extraction of leads that have been implanted for at least one year. Trials for the device, which received investigational device exemption approval Oct. 19, will involve 318 patients at up to eight clinical sites. Spectranetics expects to complete enrollment by mid-1996...
You may also be interested in...
Adalvo Hails First European Launch Of Prolonged-Release Pregabalin
After the drug’s approval for use in neuropathic pain within the EU last December, Adalvo announced the analgesic’s first European launch in Germany.
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.