Shockwave Medical has received CE Mark approval for its Lithoplasty balloon catheters designed to treat peripheral artery disease (PAD).
Lithoplasty uses integrated lithotripsy, a pulsatile mechanical energy commonly used to break up kidney stones, to disrupt superficial and deep calcium, as well as normalise vessel wall compliance prior to low-pressure balloon dilatation.
Medical University of Graz Dr Marianne Brodmann said: "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.
"With Lithoplasty, even historically very challenging PAD patients with deep calcium can be treated effectively without significant injury to the vessel."
The company said Lithoplasty was developed to be naturally gentle on soft, healthy portions of the vessel, while remaining hard on difficult-to-treat calcified tissue.
Shockwave Medical 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."
The CE Mark was based on clinical data from the multicenter Disrupt PAD trial, which was presented at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, US, in November 2014.
Data from the trial showed safe and effective dilatation of calcified stenosis with no acute failures, favourable residual stenosis, no major adverse events and no restenosis out to 30 days.
Image: Shockwave's Lithoplasty system is designed to treat patients with PAD. Photo: courtesy of Business Wire.