FastWave Medical Names Leading Vascular Specialists as Principal Investigators for Peripheral IVL Trial

Renowned endovascular specialists from Columbia and Stanford to guide pivotal trial of Artero™ electric IVL system.

MINNEAPOLIS, Sept. 30, 2025 /PRNewswire/ -- FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, today announced the appointment of its principal investigators and steering committee for the upcoming U.S. IDE pivotal trial of Artero™, the company's peripheral electric IVL (E-IVL) system.

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, will serve as co-principal investigators. They are joined by Dr. Eric Secemsky, Director of Vascular Intervention at Beth Israel Deaconess Medical Center; Dr. Marc Bonaca, Vascular Medicine & Cardiology Doctor at the University of Colorado; and Dr. Daniel Clair, Professor & Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center, 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) and support FastWave's ultimate path to FDA clearance.

PAD is a deadly condition that occurs when plaque buildup restricts blood flow to the legs and lower extremities. In the U.S., a limb is amputated every three to five minutes due to PAD, and approximately 1 in 2 patients die from amputation within 1 year. Despite its prevalence, the condition remains glaringly under-recognized and undertreated.

"Calcified lesions aren't just a technical challenge — the condition remains one of the most significant barriers to successful peripheral interventions," said Dr. 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 Dr. Chandra. "I'm excited to see how the promise of FastWave's peripheral IVL system plays out in this study."

Artero™ delivers circumferential sonic pressure waves at 4 Hz — twice the speed of legacy IVL devices — 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, CEO 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.

About FastWave Medical
FastWave Medical pioneers next-generation intravascular lithotripsy (IVL) technology to transform the treatment of calcific artery disease in peripheral and coronary applications. Founded by industry veterans with deep startup and multinational medtech experience, FastWave has secured over $50 million in venture funding to advance its dual-platform IVL systems.

The company's technologies address limitations in current calcium-modification devices by improving deliverability, energy output, and usability — eliminating extra steps while maintaining the simplicity and safety that has driven IVL's rapid adoption. Learn more at https://fastwavemedical.com.

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SOURCE FastWave Medical