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August 11, 2026
FastWave’s SPARC Pivotal Trial of Artero Peripheral IVL System Receives IDE Approval
KEY TAKEAWAYS
- FDA approved FastWave Medical’s IDE for the United States pivotal trial of the Artero peripheral IVL system.
- SPARC will evaluate the safety and effectiveness of the device in up to 125 patients with calcified peripheral lesions at 30 investigational sites.
- Sahil Parikh, MD, and Venita Chandra, MD, will serve as Coprincipal Investigators of the pivotal study.
August 11, 2026—FastWave Medical announced that it has received FDA approval of an investigational device exemption for the United States pivotal trial of the company’s Artero electric intravascular lithotripsy system for the treatment of peripheral artery disease. Artero delivers circumferential sonic pressure waves at 4 Hz through a one-click, hands-free system, noted the company.
According to FastWave, the SPARC pivotal trial will evaluate the safety and effectiveness of the Artero system in treating calcified peripheral lesions. The trial will enroll up to 125 patients across 30 investigational sites.
The company advised that the SPARC study will be led by Coprincipal Investigators Sahil Parikh, MD, and Venita Chandra, MD. Dr. Parihk is Director of Endovascular Services at Columbia University Irving Medical Center in New York, New York. Dr. Chandra is Clinical Professor of Surgery at Stanford Health Care in Stanford, California.
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