February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular Lithotripsy (IVL) system to treat severely calcified coronary artery disease.
This channel includes news and new technology innovations for atherectomy systems used in peripheral or coronary arteries to debulk lesions and vessel preparation prior to angioplasty or stenting. Atherectomy systems use laser light, spinning blades or drill tips and grinding burrs to cut away the calcified sections of the vessel wall. These systems usually have an integrated aspiration system to remove emboli from the vessel during the procedure. Removal of the calcium allows stents to be fully expanded to prop open vessels with restricted blood flow causing ischemia or a heart attack.
A comparison showing angiography and optical coherence tomography (OCT) views of an undilated mid right coronary artery calcified lesion, post dilation with the Shockwave intravascular lithotripsy system, and the final result after stenting. The technology allows calcified lesions to be broken up without the need for vessel trauma caused by high pressure balloons or atherectomy.
Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.