Minneapolis, Minnesota, August,11, 2026
FastWave Medical has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application, clearing the company to begin a U.S. pivotal clinical trial of its Artero™ electric intravascular lithotripsy (IVL) system for patients with peripheral artery disease (PAD). The regulatory milestone allows FastWave to advance Artero into pivotal-stage clinical evaluation for the treatment of calcified peripheral arterial lesions. The planned SPARC trial will evaluate the safety and effectiveness of the investigational device and represents an important step toward potential future FDA clearance.
SPARC Trial to Evaluate Artero IVL System
The SPARC pivotal study is expected to enroll up to 125 patients across 30 investigational sites in the United States. The clinical trial will assess the performance of Artero in treating calcified peripheral lesions, a challenging manifestation of peripheral artery disease. The study will be led by co-principal investigators 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.
The IDE approval allows FastWave to proceed with the clinical investigation under the FDA’s regulatory framework for significant-risk medical devices. For FastWave, the milestone moves Artero from earlier clinical evaluation into a larger pivotal study intended to generate additional evidence regarding its safety and effectiveness. The company said the trial will provide an opportunity to evaluate the capabilities of its next-generation IVL platform in patients with complex calcified peripheral artery disease. The development is particularly relevant because vascular calcification can make peripheral artery disease difficult to treat, creating challenges for device delivery and effective modification of calcified lesions. FastWave is developing Artero as an alternative approach within the growing IVL technology field.
Artero Uses High-Speed Sonic Pressure Waves
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The Artero electric IVL system is designed to deliver circumferential sonic pressure waves at 4 Hz, which FastWave says operates at up to four times the speed of legacy IVL devices. The system incorporates a one-click, hands-free operation intended to simplify use during procedures. Its rupture-resistant design and low crossing profile are also designed to support deliverability and predictable performance in complex vascular disease. Intravascular lithotripsy uses sonic pressure waves to modify vascular calcium, with the goal of facilitating treatment of calcified arterial lesions.
FastWave said its technology is designed to address limitations associated with existing calcium-modification devices by focusing on energy delivery, device deliverability and procedural usability. The company’s approach is intended to reduce additional procedural steps while maintaining the simplicity and safety characteristics that have contributed to the adoption of IVL technology. However, Artero remains an investigational device, and its safety and effectiveness for the proposed indication will be evaluated through the SPARC trial.
FastWave Advances Peripheral and Coronary IVL
The FDA IDE approval follows earlier clinical work involving FastWave’s Artero platform, including a first-in-human study, as well as a 30-patient feasibility study of the company’s Sola™ laser-based coronary IVL system. Together, these programs form part of FastWave’s broader strategy to develop IVL technologies for both peripheral and coronary applications. FastWave Medical was founded in 2021 and has raised more than $50 million in venture funding to advance its dual-platform IVL systems. The company is focused on developing technologies intended to improve treatment of calcific artery disease by addressing device deliverability, energy output and procedural efficiency.
CEO Scott Nelson described the FDA IDE approval as another step toward potential FDA clearance for Artero and highlighted the company’s focus on developing an IVL system that is fast, easy to use and highly deliverable. The company now plans to work with participating physicians and clinical sites as the SPARC pivotal trial moves forward. The IDE milestone represents a significant development in MedTech and vascular intervention, giving FastWave an opportunity to generate pivotal clinical evidence for its investigational peripheral IVL system. The eventual regulatory pathway will depend on the outcomes of the clinical study and subsequent FDA review.
Source: FastWave Medical press release
