Novel Intravascular Lithotripsy (IVL) catheter demonstrates ability to modify calcium safely, enabling treatment and crossing of tightly-stenosed lower limb lesions Technology has received U.S. FDA clearance for patients with peripheral arterial disease LAS VEGAS , Nov.
4, 2024 /PRNewswire/ -- Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced today the first clinical outcomes associated with the Shockwave Javelin Peripheral IVL Catheter, a novel, non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). Despite the challenging nature of the calcified lesions studied, the 30-day results met both prespecified performance goals while showing a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters.
The results, which helped support U.S. Food and Drug Administration clearance of the technology last month, were presented as a late breaker today at the annual Vascular InterVentional Advances (VIVA) meeting.
"The outcomes were exactly what we have come to expect from IVL studies – a strong safety profile with the low final residual stenosis that physicians would hope to achieve," said JD Corl, MD, FACC, FSCAI, Medical Director of the PAD/CLI Program at The Lindner Center for Research and Education at The Christ Hospital and Principal Investigator of FORWARD PAD Study. † "These new.
