News | January 13, 2015

Shockwave Medical Announces CE Mark Approval of its Lithoplasty System for the Treatment of Peripheral Artery Disease

Innovative treatment allows for the safe disruption of superficial and deep calcium within the vascular obstruction

Balloon catheters, cath lab, peripheral artery disease (PAD), Lithoplasty

Shockwave's Lithoplasty System, an innovative treatment for patients with peripheral artery disease (PAD).

January 13, 2015 — Shockwave Medical announced CE Mark regulatory approval for the company’s Lithoplasty balloon catheters for the treatment of peripheral artery disease (PAD).

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

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.

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

Shockwave is also investigating applying this theory to calcified coronary lesions according to the CEO and Co-founder, Daniel Hawkins.


For more information: www.shockwavemedical.com/technology

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