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Lithoplasty Device Receives FDA Clearance for Treatment of PAD
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Shockwave Medical announced the FDA granted marketing clearance to its device designed to treat calcified plaque in patients with peripheral artery disease.
According to a press release issued by the company, the device (Lithoplasty System) combines lithotripsy, a sound-wave technology used for treatment of kidney stones, with balloon catheter technology used in angioplasty.
The lithotripsy pulses disrupt calcium in the vasculature with minimal disruption to the soft tissue, while the integrated balloon restores blood flow, the company stated in the release.
“Lithoplasty represents a new mechanism of treatment and is revolutionary for the care of patients with calcified peripheral vascular disease, a difficult-to-treat patient population,” Kenneth Rosenfield, MD, MHCDS, FACC, FSCAI, section head for vascular medicine and intervention at Massachusetts General Hospital, and an Editorial Board member of Cardiology Today’s Intervention, said in a press release issued by Shockwave Medical.
“Existing devices for treating these patients have significant shortcomings that make it challenging to successfully open arteries while minimizing vascular injury and complications. Lithoplasty is a unique approach that allows us to successfully treat these diseased vessels using a device built on a familiar balloon-catheter platform while minimizing the risk of vessel injury, including dissections that require stenting or other additional interventions.”
Supporting the clearance were the results of the DISRUPT PAD study evaluating the safety and performance of the system. According to the release, the system demonstrated safety, was associated with consistent procedural success in all patient types, increased blood flow in target vessels and was linked with minimal vascular injury.
Disclosure: Rosenfield reports consulting for Shockwave Medical, receiving institutional research funding from Abbott and Bard; serving on advisory boards for Abbott, Cardinal Health, Cordis, MD Insider, Silk Road Medical and Surmodics; owning stock in Contego, MD Insider and Shockwave Medical; and serving as a compensated board member for VIVA Physicians.
Perspective
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Curtiss T. Stinis, MD, FACC, FSCAI
Calcified lesions are frequently encountered in clinical practice yet remain some of the most difficult to treat with endovascular therapies. Conventional balloon angioplasty is limited in its effectiveness due to an inability to adequately expand rigid vessels. Even if the vessel can be expanded it often recoils significantly, leading to an inability to obtain an adequate lumen for blood flow, or develops significant dissection requiring further intervention such as stenting. Currently available atherectomy devices remove only a small portion of intraluminal plaque and don’t address deeper calcium. These also therefore fail to significantly modify the overall rigidity of the vessel and their use can pose a risk for distal embolization of plaque material.
The technique of lithotripsy has a proven track record of success in other medical arenas, particularly in the treatment of kidney stones. Shockwave Medical has taken this technology and created a balloon catheter that combines lithotripsy with angioplasty with the overall goal of achieving better vessel expansion through modification of the mid and deep layers of calcium. The DISRUPT PAD Study evaluated the use of this "lithoplasty" technology in 95 patients with calcified lesions up to 15 cm in length. The device achieved 100% procedural success with all lesions demonstrating <50% residual stenosis and only one patient requiring stent placement for significant dissection. These data, albeit from a small study population, suggest that lithoplasty may be the first truly effective therapy for endovascular treatment of calcified peripheral arteries.
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