Shockwave Medical‰Ûªs Lithoplasty System gets CE mark for treatment of peripheral artery disease

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Lithoplasty is a novel balloon-based technology that uses integrated lithotripsy, a pulsatile mechanical energy commonly used to break up kidney stones, to disrupt both superficial and deep calcium and normalise vessel wall compliance prior to low-pressure balloon dilatation.

“Lithoplasty is a breakthrough that could revolutionise the treatment of peripheral artery disease a common circulatory problem that can lead to serious complications, including amputation,” said –Marianne Brodmann, Medical University of Graz, Austria.

“With Lithoplasty, even historically very challenging peripheral arterial disease patients with deep calcium can be treated effectively without significant injury to the vessel.”

In advanced vascular disease, atherosclerosis becomes calcified deep inside the vessel walls, obstructing blood flow. These deposits make today’s interventions challenging and prone to both procedural and long-term failure. Lithoplasty is designed to be naturally gentle on the soft, healthy, portions of the vessel, while remaining hard on difficult-to-treat calcified tissue.

Shockwave’s technology allows for low-pressure balloon dilatation, reducing the potential for soft tissue vascular injury, which is known to occur with current endovascular technologies.

The CE mark for Lithoplasty was supported by safety and utility clinical data from the multicentre DISRUPT PAD study, which was presented in November 2014 at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, USA. Early results demonstrated safe and effective dilatation of calcified stenosis with no acute failures, very favourable residual stenosis, no major adverse events and no restenosis out to 30 days.