FastWave Earns FDA OK for Artero Peripheral IVL Pivotal Study

FastWave Medical has gained U.S. Food and Drug Administration (FDA) approval for the IDE study of its Artero electric IVL (intravascular lithotripsy) device to treat peripheral artery disease (PAD).

The Minneapolis-based company’s SPARC trial will enroll up to 125 patients at 30 sites to treat calcified peripheral lesions. The study will be led by co-principal investigators Dr. Sahil Parikh, Director of Endovascular Services at Columbia University Irving Medical Center, and Dr. Venita Chandra, Clinical Professor of Surgery at Stanford Health Care.

Artero delivers circumferential sonic pressure waves at 4 Hz, up to four times the speed of legacy IVL devices, through a one-click, hands-free system. Its rupture-resistant design and low crossing profile are designed to shorten procedure times and deliver predictable performance, even in complex disease.

The IDE approval follows FastWave’s first-in-human study of Artero and 30-patient feasibility study of the Sola laser-based coronary IVL system.

Comments from FastWave execs

Tristan Tieso, COO: “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. 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.”

Scott Nelson, CEO: “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. 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.”