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

Shockwave Medical CEO and co-founder Daniel Hawkins said: "CE Mark approval for Lithoplasty in peripheral artery disease is an exciting milestone for Shockwave Medical and sets the stage for regulatory approvals in other geographies.

"We are also investigating applying this therapy to calcified coronary lesions – another important unmet clinical need."

According to the company, Lithoplasty has been developed to be naturally gentle on the soft, healthy portions of the vessel, while remaining hard on difficult-to-treat calcified tissue.

The approval was based on the clinical data from the multicenter Disrupt PAD study, which was presented at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, US, in November 2014.

The trial results demonstrated safe and effective dilatation of calcified stenosis with no acute failures, favorable residual stenosis, no major adverse events and no restenosis out to 30 days, noted Shockwave.

Image: Shockwave’s Lithoplasty System for the treatment of patients with peripheral artery disease. Photo: courtesy of Business Wire.