FastWave Medical today announced the appointment of its principal investigators and steering committee for the upcoming investigational device exemption (IDE) pivotal trial of Artero, the company’s peripheral electric intravascular lithotripsy (E-IVL) system.
Sahil Parikh, director of endovascular services at Columbia University Irving Medical Center in New York, USA and Venita Chandra, clinical professor of surgery at Stanford Health Care in Stanford, USA, will serve as co-principal investigators. They are joined by Eric Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston, USA; Marc Bonaca, Vascular Medicine and cardiology doctor at the University of Colorado in Boulder, USA; and Daniel Clair, professor and chair of the department of vascular surgery at Vanderbilt University Medical Center in Nashville, USA, who will help guide the trial’s clinical strategy.
The study will evaluate the safety and effectiveness of the Artero IVL system in treating peripheral arterial disease (PAD).
“Calcified lesions aren’t just a technical challenge—the condition remains one of the most significant barriers to successful peripheral interventions,” said Parikh. “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.”
“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,” said Chandra. “I’m excited to see how the promise of FastWave’s peripheral IVL system plays out in this study.”
In a recent press release, the company have stated that Artero delivers circumferential sonic pressure waves at 4Hz—twice the speed of legacy IVL device—through a one-click, hands-free system. Its rupture-resistant balloon and low crossing profile are engineered to streamline procedures and maintain reliable performance, even in complex disease.
“With Artero, one of our primary goals is to give physicians a system they can use with more confidence and predictability—combining speed, simplicity, and reliability to treat all forms of calcified lesions,” said Scott Nelson, chief executive officer of FastWave Medical.
This announcement comes as FastWave advances both of its IVL platforms, including its coronary feasibility study of the Sola laser-based IVL system, which commenced in May 2025.
