January 6, 2015
Shockwave's Lithoplasty System for PAD Receives CE Mark Approval
January 7, 2015—Shockwave Medical announced European CE Mark approval for the company’s Lithoplasty balloon catheters for the treatment of peripheral artery disease (PAD).
According to the company, 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 before 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. The technology allows for low-pressure balloon dilatation, reducing the potential for soft tissue vascular injury.
Delivered on a standard balloon catheter platform, Lithoplasty applies a brief series of powerful mechanical pulses designed to safely travel through soft tissue to disrupt and pretreat 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 long-term restenosis or the need for additional interventional treatments, stated the company.
In Shockwave Medical’s announcement, Marianne Brodmann, MD, commented, “Lithoplasty is a breakthrough that could revolutionize the treatment of PAD—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.” Dr. Brodmann is from the Medical University of Graz, Austria.
Shockwave Medical advised that clinical results to date have demonstrated safety, tolerability, deliverability, and effectiveness of Lithoplasty as a treatment for patients with PAD. Clinical work has also been conducted in coronary vessels and will begin in aortic valves later this year.
For treatment of peripheral arteries, the CE Mark approval for Lithoplasty was supported by safety and utility clinical data from the multicenter DISRUPT PAD study, which was presented in November at the VIVA 2014: Vascular Interventional Advances 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.
For coronary arteries, results from the first-in-man study of five patients with moderate to severe coronary calcification were presented in September at TCT 2014, the 26th annual Transcatheter Cardiovascular Therapeutics scientific symposium, in Washington, DC. Those results demonstrated safety, tolerability, deliverability, and effectiveness for Lithoplasty as a pretreatment of calcified coronary lesions before stenting.