Lithoplasty System Treats Peripheral Artery Disease

A novel system combines the calcium disrupting power of lithotripsy with the simplicity of a balloon catheter into a single device.

The Lithoplasty system is designed to disrupt and pretreat calcium deposits present in peripheral artery disease (PAD) by applying a brief series of powerful mechanical pulses through the soft tissue. The plaque, having been stressed from the induced vibrations, thus becomes more pliable. The integrated balloon catheter is then dilated at low pressures to expand the lesion evenly without damaging the vessels themselves, minimizing any potential acute soft tissue injury that could lead to the need for additional interventional treatments or long-term restenosis.

The balloon dilatation catheter incorporates tiny lithotripsy electrodes that increase the compliance of rigid vascular and valvular lesions prior to the low-pressure dilation. The pretreatment enables more effective angioplasty, less frequent bailout stent usage, and enhanced lesion preparation. In aortic valves, the technology could vastly improve native tissue preparation prior to trans-catheter aortic valve replacement (TAVR) and valvuloplasty for patients not suitable for TAVR. The Lithoplasty system is a product of Shockwave Medical (Fremont, CA, USA), and has received the European Community CE marking of approval.

“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,” said Daniel Hawkins, co-founder of Shockwave Medical. “We are also investigating applying this therapy to calcified coronary lesions, another important unmet clinical need.”

“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, MD, 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.”

Related Links:
Shockwave Medical
Medical University of Graz