Shockwave Prepares For FDA Approval Of Coronary Intravascular Lithotripsy System
The company expects the FDA to approve its intravascular lithotripsy system with the C2 coronary catheter in early 2021 based on results from the Disrupt CAD III study.
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Shockwave Medical received a FDA premarket approval for its C2 coronary intravascular lithotripsy-based calcification remedy and announced its 2020 results, in line with expectations.
Device Debuts: Medtronic MiniMed 670G HCL Insulin Pump; OrbusNeich Sapphire Coronary Balloons; Shockwave Lithoplasty; DePuy Synthes' Fenestrated Spine Screws; Philips Monitoring And Imaging Systems
This edition of Medtech Insight's Device Debuts covers the innovative devices introduced into commercial markets since mid-May, including Medtronic's long-awaited launch of the MiniMed 670G Hybrid Closed Loop insulin pump system, OrbusNeich's entry into the US coronary dilation catheter market, and Shockwave's Lithoplasty system for treating calcified peripheral arteries.
The company stopped shipping Alaris in early 2020 after the FDA requested a new 510(k) for modifications and the device has been the subject of several recalls since then.