The approval clears the company to begin a U.S. pivotal trial of its Artero electric IVL system designed to treat peripheral artery disease.
“Reaching IDE approval takes a lot of people believing in this work, and I’m grateful to every employee, physician, and partner who helped us get here,” FastWave Medical COO Tristan Tieso said. “We’re looking forward to demonstrating the capabilities of Artero in a rigorous IDE trial, and ultimately bringing an advanced IVL platform to the patients who need it most.”
The trial will enroll up to 125 patients across 30 investigational sites and will evaluate the safety and effectiveness of the company’s Artero IVL system in treating calcified peripheral lesions.
Related: The new J&J Shockwave C2 Aero IVL device is faster and more flexible
Artero is designed to shorten procedure times and provide predictable outcomes, even with complex diseases. Artero features a reduced crossing to navigate difficult anatomy and an optimized shaft for easier pushability. FastWave designed Artero with a rupture-resistant balloon for consistent results in challenging vessels.
The system’s novel emitter delivers sonic pressure at 4 Hz, twice as fast as currently available IVL systems, through a one-click, hands-free system, the company said.
“I’m extremely proud of the resiliency our employees and partners have shown to reach this milestone, which brings FastWave another step closer to FDA clearance,” FastWave Medical CEO Scott Nelson said. “I also want to credit FDA and its review team for being very responsive and keeping our submission moving forward. We designed Artero to be fast, easy-to-use, and highly deliverable, and we’re excited to partner with leading physicians on this IDE trial.”
The IVL market continues to heat up. Johnson’s Shockwave Medical leads the IVL space, but other companies like Stryker, Boston Scientific and Abbott are looking to break through.
Stryker acquired Amplitude Vascular Systems to enter the space in May. Boston Scientific acquired Bolt Medical in April 2025, just days after the FDA granted 510(k) clearance for the Bolt IVL system. Abbott’s also developing a coronary IVL system, which received IDE approval in March 2025.
Elixir Medical and Vantis Vascular are also on the radar, developing IVL platforms.
