Dave Fornell, DAIC Editor

Dave Fornell, editor of DAIC Magazine

Blog | Dave Fornell, DAIC Editor | Cath Lab| March 16, 2021

Coronary Lithotripsy May Become a Paradigm Shift in the Cath Lab

The Shockwave intravascular lithotripsy system produces a flash of light as it releases a sonic shockwave, as seen here as it is about to shatter a gypsum bead during a TCT 2019 demonstration at the vendor's booth. The technology combines a miniaturized lithotripsy system with a low-pressure balloon catheter to expand peripheral or coronary arteries without causing vessel trauma. Photo by Dave Fornell

The Shockwave intravascular lithotripsy system produces a flash of light as it releases a sonic shockwave, as seen here as it is about to shatter a gypsum bead during a TCT 2019 demonstration at the vendor's booth. You can see the cracks forming as the bead breaks apart in the right bead. The technology combines a miniaturized lithotripsy system with a low-pressure balloon catheter to expand peripheral or coronary arteries without causing vessel trauma. Photo by Dave Fornell

After covering cardiovascular technologies for 14 years, it is rare that I find a new technology that might actually be a paradigm shift in cardiology. Most new devices I see are just refined iterations of existing devices, or the vendor added a new button or set of measurement tools. However, I do occasionally find a true gem while sitting in on hours of new technology sessions at conferences, or while wandering the expo floors. 

One such gem that may soon become a paradigm shift just gained U.S. Food and Drug Administration (FDA) clearance to treat calcified coronary arteries. The Shockwave Medical Intravascular Lithotripsy uses sonic wave pulses and a low pressure 4 atm compliant balloon to break up heavy calcium without vessel trauma. Vessel trauma is currently the only way to break up these lesions to prep them for stenting using either high pressure balloons, cutting balloons or atherectomy. I first saw this catheter technology break egg shells set inside gelatin as a bench test video during a new futuristic innovations session at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 meeting. I closely followed this technology ever since because of its possibility to be disruptive in interventional cardiology. At later TCT meetings, I saw preclinical and later clinical fluoro imaging of heavily calcified peripheral leg lesions magically reopen in seconds using this technology. 

Intravascular lithotripsy gained FDA clearance for peripheral artery disease (PAD) in 2016, and the company began working toward an additional indication for the coronaries. It was granted FDA clearance in February 2021. The FDA also recognized this technology as a breakthrough technology because it offers a solution to a long-standing clinical problem.

The FDA pivotal trial for the coronary indication was presented as a late-breaker at TCT 2020 by Dean Kereiakes, M.D., FACC, FSCAI, president of The Christ Hospital Heart and Vascular Institute. He said this technology is a paradigm shift. Hear more on what he had to say about the data and the technology in the VIDEO: Intravascular Lithotripsy to Treat Severely Calcified Coronary Artery Lesions.

Lastly, when looking at new technologies, I always consider how practical it is to use. I have seen a lot of really interesting technologies over the years, but some were just too cumbersome or too difficult to use or interpret, or did not offer enough of an advantage over the current standard of care. In evaluations for practicality, I use the gauge that if it is something I would feel comfortable using after a 15 minute tutorial (and keep in mind I am not a cardiologist) it will probably see wide-spread use in cath labs. Shockwave’s intravascular lithoplasty is one of these technologies that is very easy to use and it solves an age-old problem of how to build a better mouse trap in dealing with coronary calcium.   

Here is a a very quick demo of the technology I shot on my iPhone on the expo floor of TCT 2019 where it quickly shatters gypsum beads — VIDEO: Demonstration of Intravascular Lithotripsy Breaking Up Calcium.

Here are other articles and video interviews on this technology from the past few years DAIC followed it through pre-clinical, clinical and regulatory reviews.

FDA Clears Coronary Intravascular Lithotripsy to Breakup Calcified Lesions With Sound Waves 

VIDEO: Clinical Example of Coronary Lithotripsy to Break up Calcified Lesion

Intravascular Lithotripsy: Will This New Investigational Technology Crack Calcium’s Code in the U.S.? — Article by DISRUPT CAD III investigators  Dean Kereiakes, M.D., and Jonathan Hill, M.D.

FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy

VIDEO: Breaking Up Calcified Lesions Without Vessel Trauma — Interview with Todd Brinton, M.D.

FDA Clears Lithoplasty Balloon That Shatters Calcified PAD Lesions With Ultrasound

Lithotripsy Safe and Effective in Calcified Stenotic Peripheral Arteries

Intravascular Lithotripsy May Offer Solution for Calcified Coronary Lesions — Article By Azeem Latib, M.D.

VIDEO: How a Lithoplasty Balloon Shatters Calcified Plaque in Arteries With Ultrasound

Related Content

AGENT IDE will evaluate the AGENT DCB as potential therapy for patients with in-stent restenosis, may offer alternative to repeated stenting or radiation therapy
News | Balloon Catheter | May 20, 2021
May 20, 2021 — Boston Scientific Corporation announced it has initiated the...
Example of an angioplasty balloon catheter being expanded inside an artery to push atherosclerotic plaque and thrombus out of the way to reopen the vessel lumen to increase or reopen bloodflow. Balloon catheters are used to revascularize patients with heart attacks and to deploy stents to prop open the expended vessel.

Getty Images

Feature | Balloon Catheter | March 16, 2021 | By Dave Fornell, Editor
The first devices developed for interventional cardiology were...
A comparison showing angiography and optical coherence tomography (OCT) views of an undilated mid right coronary artery calcified lesion, post dilation with the Shockwave intravascular lithotripsy system, and the final result after stenting. The technology allows calcified lesions to be broken up without the need for vessel trauma caused by high pressure balloons or atherectomy. 

A comparison showing angiography and optical coherence tomography (OCT) views of an undilated mid right coronary artery calcified lesion, post dilation with the Shockwave intravascular lithotripsy system, and the final result after stenting. The technology allows calcified lesions to be broken up without the need for vessel trauma caused by high pressure balloons or atherectomy.

Feature | Balloon Catheter | February 17, 2021
February 17, 2021 — The U.S.
Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula. This is a new type of scoring balloon technology.
News | Balloon Catheter | June 04, 2020
June 4, 2020 — Transit Scientific announced the U.S.
NC Trek RX Coronary Dilatation Catheter is part of an FDA Class I recall because it may not defalte.
News | Balloon Catheter | February 24, 2020
February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters
Edwards Lifesciences Recalls IntraClude Intra-aortic Occlusion Device
News | Balloon Catheter | July 15, 2019
Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon rupture during...
Gore Molding & Occlusion Balloon for Endovascular Aortic Repair Receives FDA Approval
Technology | Balloon Catheter | August 23, 2018
W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Gore...
Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance  of Sapphire II Pro 1mm Coronary Balloon
Technology | Balloon Catheter | March 21, 2018
Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k...
Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports