Johnson & Johnson MedTech’s Shockwave Medical is launching a new intravascular lithotripsy catheter in the U.S. that aims to clear a path through extremely narrowed or blocked blood vessels in patients with peripheral artery disease.
While the company’s previous catheters are designed to emit sonic pressure waves around their circumference—to crack calcium deposits from within the artery, once they’ve been threaded through a lesion—the Javelin system is designed to deliver energy ahead, from its tip.
This may allow it to cross challenging and complex blockages in the legs, where a thinner guidewire can pass through but a wider catheter may not.
According to J&J, the Javelin can deliver up to 120 pulses in a spherical energy field, while getting closer to calcium deposits than its balloon-based approaches.
The company also said the Javelin demonstrated a similar safety and effectiveness profile in a clinical trial compared to Shockwave’s other lithotripsy catheters. In a presentation last November, J&J said Javelin demonstrated a procedure success rate of 99%, with a major complication rate of 1.1% after 30 days.
The device received a 510(k) clearance from the FDA last September.
Shockwave estimates that peripheral artery disease affects more than 8 million people in the U.S. ages 40 and up, with the most severe forms causing amputations and a 50% mortality rate after five years.