Shockwave Medical Releases New Peripheral Catheter in U.S.

Shockwave Medical Inc. has launched the Shockwave E⁸ Peripheral IVL Catheter in the United States. Cleared by the U.S. Food and Drug Administration (FDA), the Shockwave E⁸ catheter is designed to optimize the treatment calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI).
 
PAD affects more than 8 million people aged 40 and older in the United States.¹ People suffering from PAD have not only impaired quality of life but also increased risk of heart attack or stroke.² CLTI is the most advanced and serious form of PAD, impacting nearly 2 million U.S. patients and is associated with 40% major amputations at one year, and a 50% mortality rate at five years,³ worse than most forms of cancer.
 
“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,” said Venita Chandra†, M.D., vascular surgeon and clinical associate professor, Division of Vascular Surgery, at Stanford Health Care. “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.”
 
With 400 pulses delivered twice per second, and eight emitters across an 80mm balloon, Shockwave E⁸ can treat longer lesions more efficiently, the company claims. With an increased catheter working length of 150cm, physicians can extend their IVL treatment to reach below-the-knee and very distal lesions. Combined with Shockwave L⁶, Shockwave M⁵⁺, and Shockwave S⁴ IVL catheters, the addition of Shockwave E⁸ offers physicians a complete IVL portfolio to treat challenging calcified lesions across the entire peripheral anatomy.
 
“Shockwave E⁸ represents our commitment to physician-guided innovation while maintaining the simplicity and effectiveness of our IVL technology,” Shockwave Medical President Isaac Zacharias stated. “We have received very positive physician feedback on Shockwave E⁸ and look forward to establishing it as our new workhorse peripheral IVL catheter for physicians addressing challenging calcium above and below the knee.”
 
Shockwave Medical, part of Johnson & Johnson MedTech,* develops and commercializes products to improve cardiovascular disease treatment. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed atherosclerotic cardiovascular disease treatment, according to the company, by using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to patients suffering from refractory angina by redistributing blood flow within the heart. 
 
At Johnson & Johnson, health is everything. Through its expertise in innovative medicine and medtech, the company is positioned to innovate across the full spectrum of healthcare solutions today to profoundly impact health. Its MedTech sector boasts global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions.

* Comprising the surgery, orthopaedics, vision, and cardiovascular businesses within Johnson & Johnson’s MedTech segment.
† Dr. Chandra is a paid consultant for Shockwave Medical. She has not been compensated in connection with this press release.

References
¹ https://www.nhlbi.nih.gov/health/peripheral-artery-disease
² https://www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html
³ https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007539