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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The EMPOWER CAD trial will evaluate Shockwave’s intravascular lithotripsy system in female patients undergoing a percutaneous coronary intervention for coronary artery disease. Principal investigator Alexandra Lansky spoke to Medtech Insight about the first-of-its kind study in this understudied population.
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.