Shockwave Medical has announced CE Mark regulatory approval for the company’s Lithoplasty balloon catheters for the treatment of peripheral artery disease (PAD).
Lithoplasty is a novel 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 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 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.
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.
“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 and 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, Stanford University.