Santa Clara, California-based Shockwave launched the intravascular lithotripsy (IVL) catheter following FDA clearance. It designed the catheter to optimize the treatment of patients with calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD). That includes patients with complex chronic limb-threatening ischemia (CLTI).
Johnson & Johnson acquired Shockwave and its IVL technology for $13.1 billion in May.
Dr. Venita Chandra, a vascular surgeon at Stanford Health Care, said that the new catheter offers “significant improvements.” The improvements could help physicians refine treatment algorithms and support challenging patients with heavily calcified disease, Chandra said.
“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,” said Chandra.
According to Shockwave, the new catheter delivers 400 pulses twice per second with eight emitters across an 80 mm balloon. This helps to treat longer lesions more efficiently. Its increased catheter working length of 150 cm, helping extend treatment below the knee and to very distal lesions.
Shockwave said its E8, combined with the L6, M5+ S4 IVL catheters, helps deliver a complete IVL portfolio.
“Shockwave E8 represents our commitment to physician-guided innovation while maintaining the simplicity and effectiveness of our IVL technology,” said Isaac Zacharias, president, Shockwave Medical. “We have received very positive physician feedback… and look forward to establishing it as our new workhorse peripheral IVL catheter for physicians addressing challenging calcium above and below the knee.”
