FDA approves pivotal trial for FastWave Medical's peripheral IVL system
The U.S. Food and Drug Administration (FDA) granted approval for FastWave Medical to begin a investigational device exemption (IDE) pivotal study to evaluate its electric intravascular lithotripsy (IVL) system in patients with peripheral artery disease (PAD).
The SPARC trial will enroll up to 125 patients across 30 investigational sites. The study is designed to explore the safety and efficacy of the Artero electric IVL system in treating calcified peripheral lesions. The study will be led by co-principal investigators 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.
Artero delivers sonic pressure waves at 4 Hz, up to four time the speed of legacy IVL devices using a one-click, hands-free system. The device uses a rupture-resistant design and low-crossing profile to increase access to tight lesions and shorten procedure times.
"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," Tristan Tieso, COO of FastWave Medical, said in a statement. "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."
The IDE approval follows positive outcomes from a first-in-human study of the Artero platform and a 30-patient feasibility study of its Sola laser-based coronary IVL system.
FastWave is one of several companies developing new IVL systems that will compete with Shockwave Medical's first-to-market IVL systems. The company said its technologies address key limitations in current IVL systems by improving deliverability, energy output and easier usability. This includes eliminating extra procedural steps while maintaining safety.
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]