Shockwave E8 Peripheral IVL Catheter Launched

September 16, 2024—Shockwave Medical, Inc., part of Johnson & Johnson MedTech, announced the FDA clearance and full United States launch of the Shockwave E8 peripheral intravascular lithotripsy (IVL) catheter. The Shockwave E8 catheter is designed to treat patients with calcified femoropopliteal and below-the-knee peripheral artery disease, including patients with complex chronic limb-threatening ischemia (CLTI).

According to the company, the Shockwave E8 device offers 400 pulses twice per second and eight emitters across an 80-mm balloon, allowing it to treat longer lesions more efficiently. An increased catheter working length of 150 cm allows physicians to extend their IVL treatment to reach below-the-knee and very distal lesions.

The Shockwave E8 joins the company’s IVL catheter portfolio, which includes the Shockwave L6, Shockwave M5+, and Shockwave S4 for treatment of challenging calcified lesions across the entire peripheral anatomy, stated the company.

“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,” commented Venita Chandra, MD, in the company’s press release.

Dr. Chandra, vascular surgeon and Clinical Associate Professor in the Division of Vascular Surgery at Stanford Health Care in Stanford, California, continued, “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.”