Shockwave Medical’s Lithoplasty System FDA Cleared

18 October 2016

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Shockwave Medical have gained FDA approval of their Lithoplasty system for the treatment of calcified plaque in patients with peripheral arterial disease. It’s thought to be the first device able to specifically identify and seek out hardened calcium in patients with cardiovascular disease.

Lithoplasty-system.

It works by combining angioplasty balloon catheter equipment and sound wave technology which disturbs the calcium (known as Lithotripsy.) Ongoing lithotripsy pulses then disturbs both superficial and deep vascular calcium, whilst curtailing soft tissue damage. Then, the angioplasty balloon serves to expand blockages at low pressures to re-establish blood flow.

The fact that it’s the first of its kind to minimises soft tissue damage during treatment is what magnifies its competitive edge within the market.

We’re excited to see the Shockwave Medical’s Lithoplasty System go to market, and look forward to the real life examples of its life-changing capabilities.


Nicola Lawler, Head of Marketing at Projectus Consulting