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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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 FAST 01 feasibility trial is evaluating a modification to Varian’s ProBeam particle accelerator that enables ultra-high dose radiation to treat cancer.
Data from the EARLY AF First, Cryo-FIRST and STOP AF trials show cryoablation is a better option than drugs for patients with symptomatic atrial fibrillation.