Lithoplasty Technology Treats Coronary Artery Disease

A combination of balloon angioplasty and lithotripsy breaks up calcified plaques that cause arteries to narrow and restores blood flow.

The Shockwave Medical lithoplasty system is comprised of balloon dilatation catheter with inset lithotripsy electrodes that increase the compliance of rigid vascular and valvular lesions. The vascular calcium deposits are then subjected to a brief series of powerful mechanical pulses. Stressed from the induced vibrations, the plaque becomes more pliable; the integrated balloon catheter is then dilated at low pressures to expand the lesion evenly, without damaging the vessels themselves.

The pre-treatment enables more effective angioplasty, less frequent bailout stent usage, and enhanced lesion preparation, thus minimizing any potential acute soft tissue injury that could lead to the need for additional interventional treatments or long-term restenosis. The technology is currently undergoing a premarket, prospective, single-arm study in seven sites in Europe and Australia in order to evaluate the use of lithoplasty for treat calcified arteries in CAD patients before they receive a drug-eluting stent.

“Cardiovascular calcification presents a persistent treatment challenge for the interventionalist,” said Jean Fajadet, MD, of Clinique Pasteur (Toulouse, France), co-principal investigator of the international clinical trial of the technology. “The use of lithoplasty in the coronary arteries is an important new option that has shown in the clinical study of the device to effectively prepare the vessel for stent implantation with minimal complications.”

“We are a step closer to bringing lithoplasty to patients and physicians in Europe as a potentially paradigm-changing technology for the treatment of coronary artery disease,” said Doug Godshall, CEO of Shockwave Medical. “We look forward to sharing our final six-month results…and to continuing to gather clinical evidence on the benefits of this promising treatment for a challenging patient population.”

The presence of calcified CAD leads to suboptimal outcomes for all treatment options - medical therapy, interventional treatment, and cardiac surgery. For angioplasty with a stent, the presence of calcified lesions is associated with suboptimal lesion expansion, poor stent apposition, and complications that include dissection, distal embolization, coronary hypoperfusion, and procedural failure.