FDA clears IVL catheter for treatment of below-the-knee PAD
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Key takeaways:
- Shockwave Medical announced the FDA clearance and U.S. launch of its peripheral intravascular lithotripsy (IVL) catheter.
- It is designed to treat calcified femoropopliteal and below-the-knee PAD and CLTI.
Shockwave Medical announced the FDA clearance and full U.S. launch of its peripheral intravascular lithotripsy catheter designed to treat calcified femoropopliteal and below-the-knee peripheral artery disease.
The catheter (Shockwave E8) is also designed to treat patients with chronic limb-threatening ischemia, the most advanced and serious form of PAD, according to a press release issued by the company.
The catheter is designed to deliver 400 pulses twice per second from eight emitters across an 80 mm balloon, and with catheter working length of 150 cm, intravascular lithotripsy treatment can reach below-the-knee and distal lesions, according to the release.
“Shockwave's newest peripheral catheter offers significant improvements that will help physicians refine their treatment algorithm and better support challenging patients with heavily calcified disease,” Venita Chandra, MD, vascular surgeon and clinical associate professor in the division of vascular surgery at Stanford Health Care, said in the release. “The catheter’s ability to treat long lesions and its extended reach enable safe and effective treatment of some of our most difficult-to-treat patients, including those with CLTI, a complicated and severe disease state with a high mortality rate.”
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