Shockwave’s IVL technology gains FDA approval for treating advanced coronary artery disease

Michael Walter | | Cardiovascular Business | Vascular & Endovascular
The Shockwave Medical M5+ new peripheral intravascular lithotripsy (IVL) catheter cuts procedures times in half and was showed for the first time at the American College of Cardiology (ACC) 2022 meeting. It is designed to break up calcium in heavily calcified arteries to avoid the need for vessel trauma caused by high pressure angioplasty.

Intravascular lithotripsy image courtesy of Shockwave Medical.

Shockwave Medical announced Tuesday, Feb. 16, that intravascular lithotripsy (IVL) has gained U.S. FDA approval for the treatment of severely calcified coronary artery disease.

Shockwave started developing IVL in 2009. The technology is already approved for treating peripheral arterial disease.

Doug Godshall, Shockwave’s president and CEO, described this latest approval in a statement as “the culmination of years of technical research, rigorous clinical studies and key learnings from our real-world global experience.”

“We are eager for U.S. cardiologists to have access to this technology and experience how a safe, efficient and predictable calcium modification strategy can positively impact their clinical outcomes,” he added.

The Shockwave statement also highlighted recent research published in the Journal of the American College of Cardiology. The authors of that study, first shared with the public in October 2020, found that IVL “safely and effectively facilitates stent delivery and optimizes stent expansion in patients with severely calcified coronary lesions.”

Another analysis focused on IVL treatment was published in Circulation: Cardiovascular Interventions in September 2020.

 

Related Content on Intravascular Lithotripsy to Break Up Calcified Lesions:

VIDEO: Shockwave Medical demonstrates faster intravascular lithotripsy at ACC22

Better Together? An Integrated Market for Calcium-modification Strategies

IVL Turns Standard Balloon Technology into a Powerful Calcium-disruption Tool

CMS recommends additional payment for using Shockwave’s IVL technology in hospital setting

Michael Walter
Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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