FastWave Names Leadership for Pivotal Trial of Artero Electric IVL System

September 30, 2025—FastWave Medical, a developer of intravascular lithotripsy (IVL), announced the appointment of the principal investigators and steering committee for the upcoming United States investigational device exemption pivotal trial of the company’s Artero peripheral electric IVL system.

The trial’s coprincipal investigators are Sahil Parikh, MD, and Venita Chandra, MD, and the steering committee includes Eric Secemsky, MD; Marc Bonaca, MD; and Daniel Clair, MD.

FastWave stated that the Artero device delivers circumferential sonic pressure waves at 4 Hz through a one-click, hands-free system. It features a rupture-resistant balloon and a low crossing profile to streamline procedures and maintain reliable performance, even in complex disease.

According to FastWave, the study will evaluate the safety and effectiveness of the Artero IVL system in treating peripheral arterial disease and support FastWave’s path to FDA clearance.

“Calcified lesions aren’t just a technical challenge—the condition remains one of the most significant barriers to successful peripheral interventions,” commented Dr. Parikh in the company’s press release. “FastWave’s pivotal trial gives us a chance to assess whether an advanced IVL system can meaningfully improve the lives of patients who suffer from this difficult disease.” Dr. Parikh is Director of Endovascular Services at Columbia University Irving Medical Center in New York, New York.

Dr. Chandra, Clinical Professor of Surgery at Stanford Health Care in Stanford, California, added, “The key question isn’t just whether a device works but whether it makes procedures more efficient and provides physicians with a more predictable tool for treating patients with complex arterial disease. I’m excited to see how the promise of FastWave’s peripheral IVL system plays out in this study.”