FastWave lines up principal investigators for pivotal intravascular lithotripsy trial
Intravascular lithotripsy (IVL) startup FastWave Medical announced its principal investigators and steering committee for its upcoming U.S. investigational device exemption (IDE) pivotal trial of Artero peripheral electric IVL (E-IVL) system, used to treat peripheral arterial disease (PAD).
Sahil Parikh, MD, director of endovascular services at Columbia University Irving Medical Center, and Venita Chandra, MD, clinical professor of surgery at Stanford Health Care, will serve as co-principal investigators. The steering committee includes Eric Secemsky, MD, director of vascular intervention at Beth Israel Deaconess Medical Center; Marc Bonaca, MD, director of vascular research at the University of Colorado; and Daniel Clair, MD, professor and chair of the Department of Vascular Surgery at Vanderbilt University Medical Center. They will help guide the trial's clinical strategy.
"Calcified lesions aren't just a technical challenge, the condition remains one of the most significant barriers to successful peripheral interventions," said Parikh in a statement. "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."
IVL therapy has seen rapid expansion the past few years in treating heavily calcified arterial lesions. IVL uses sonic pressure to crack calcium without the vessel trauma that goes with traditional balloon angioplasty. The Artero delivers circumferential sonic pressure waves at 4 Hz, twice the speed of current devices. It uses a rupture-resistant balloon and low-crossing profile designed to help streamline procedures.
"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," explained Chandra in a statement. "I'm excited to see how the promise of FastWave's peripheral IVL system plays out in this study."
The company has developed two platforms, including the Sola laser-based IVL system, which started a coronary artery feasibility study in May 2025.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]