Shockwave Medical Receives CE Mark Approval for Lithoplasty System

Shockwave Medical has received CE Mark regulatory approval for its Lithoplasty balloon catheter treatment of peripheral artery disease (PAD).

Lithoplasty is a 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 normalize vessel wall compliance prior to low-pressure balloon dilatation.

“Lithoplasty is a breakthrough that could revolutionize the treatment of peripheral artery disease – a common circulatory problem that can lead to serious complications, including amputation,” said Marianne Brodmann, M.D., of the Medical University of Graz, Austria. “With Lithoplasty, even historically very challenging PAD 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 current 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 company claims.

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, Nev. 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.

“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,” said Shockwave Medical CEO/co-founder Daniel Hawkins. “Our initial clinical results in the coronaries are promising. Data presented at TCT 2014 from our First-In-Man study demonstrated safety, tolerability, deliverability, and effectiveness.”

“We look forward to bringing this disruptive technology to patients with challenging calcified lesions in a number of vascular beds, as well as applying the technology platform to calcified valvular disease,” said Todd Brinton, M.D., co-founder of Shockwave Medical and clinical associate professor of Interventional Cardiology at Stanford University in California.

Unlike current devices that treat only superficial calcium, Shockwave’s Lithoplasty system is designed to be effective on all types of calcium, including deep – the type known to limit vessel expansion. Delivered on a standard balloon catheter platform, Lithoplasty combines the calcium disrupting power of lithotripsy with the familiarity and simplicity of a balloon in a single enabling device, Shockwave Medical bigwigs note. Lithoplasty applies a brief series of powerful mechanical pulses designed to safely travel through soft tissue, disrupt and pre-treat calcium. The integrated balloon is then dilated at low pressures to expand the lesion evenly, potentially minimizing acute soft tissue injury that could lead to the need for additional interventional treatments or long-term restenosis (re-blockage).

Clinical results to date have demonstrated safety, tolerability, deliverability, and effectiveness of Lithoplasty as a treatment for patients with peripheral artery disease. Clinical work has also been conducted in coronary vessels, and will begin in aortic valves later this year.

Based in Fremont, Calif., Shockwave Medical develops advanced peripheral and coronary vascular disease treatments.