J&J’s Shockwave Medical Unveils E⁸ Catheter for Complex Peripheral Artery Disease

Johnson & Johnson MedTech’s Shockwave Medical has launched its latest innovation, the E⁸ peripheral intravascular lithotripsy (IVL) catheter, in the U.S. This cutting-edge device is designed to tackle some of the toughest cases of peripheral artery disease (PAD), a condition that affects over eight million Americans, particularly those aged 40 and older. PAD occurs when arteries outside of the heart, usually in the legs, become narrowed or blocked due to plaque buildup, restricting blood flow. Among those affected, around two million suffer from chronic limb-threatening ischemia (CLTI), the most severe form of the disease, often leading to pain, infections, and, in many cases, amputations.

The new E⁸ catheter is equipped with eight emitters that deliver a high-frequency burst of 400 pulses per second. These pulses generate sonic pressure waves that travel through the artery, cracking hardened calcium deposits within the vessel walls. This helps restore blood flow and provides a less invasive, more effective solution compared to traditional treatments like angioplasty or stenting. Historically, these methods involved physically pushing plaques aside, but calcified blockages are more resistant to such techniques. With the E⁸ IVL, however, the hard calcium is broken up more efficiently, allowing for easier placement of a stent if necessary.

The U.S. Food and Drug Administration (FDA) gave its stamp of approval to the E⁸ catheter in March 2024, marking a major milestone for Shockwave Medical. This follows Johnson & Johnson’s $13.1 billion acquisition of the company earlier in the year, one of the largest deals in medtech in recent years. The acquisition underscores J&J's commitment to expanding its presence in the cardiovascular device market.

Since entering the field of IVL technology in 2018 for peripheral artery disease and 2021 for coronary artery disease (CAD), Shockwave Medical has made a massive impact. Its products now dominate the market, capturing 32% of the peripheral angioplasty market and 58% of the coronary angioplasty market in just a few years.

The E⁸ catheter builds on the success of earlier models like the L6, M5+, and S4, but with improvements. One standout feature is its 150cm working length, making it easier for doctors to reach blockages in more remote, difficult-to-treat areas below the knee. Shockwave Medical President Isaac Zacharias has highlighted the overwhelmingly positive feedback from physicians, who see the device as a game-changer in addressing complex, calcified lesions.

This device is part of Shockwave’s broader vision to tackle both peripheral and coronary artery disease through IVL technology, which has transformed the way physicians treat these conditions. For patients with PAD and CLTI, the E⁸ offers hope for better outcomes, reducing the risk of severe complications like amputation, and helping to restore mobility and quality of life.