FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero Peripheral IVL System
核心洞察
FastWave Medical (搜索) received FDA Investigational Device Exemption (IDE) approval to launch a U.S. pivotal trial of its Artero (搜索) electric intravascular lithotripsy (IVL) system for peripheral artery disease (搜索) (PAD).
The SPARC trial will enroll up to 125 patients across 30 investigational sites to evaluate the safety and effectiveness of Artero (搜索) in treating calcified peripheral lesions.
Artero (搜索) delivers circumferential sonic pressure waves at 4 Hz, up to 4x the speed of legacy IVL devices, via a one-click, hands-free system designed to shorten procedure times.
FastWave Medical (搜索), a developer of next-generation intravascular lithotripsy (IVL) technology, has received FDA approval of its Investigational Device Exemption (IDE) application, clearing the company to begin a U.S. pivotal trial of its Artero (搜索) electric IVL system for the treatment of peripheral artery disease (搜索) (PAD).
The SPARC trial will enroll up to 125 patients across 30 investigational sites and will evaluate the safety and effectiveness of Artero (搜索) in treating calcified peripheral lesions. 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.
"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," said Tristan Tieso, COO of FastWave Medical (搜索). "We're looking forward to demonstrating the capabilities of Artero (搜索) in a rigorous IDE trial, and ultimately bringing an advanced IVL platform to the patients who need it most."
Artero Platform Technology
Artero (搜索) delivers circumferential sonic pressure waves at 4 Hz, up to 4x the speed of legacy IVL devices, through a one-click, hands-free system. Its rupture-resistant design and low crossing profile are designed to shorten procedure times and deliver predictable performance, even in complex disease.
"I'm extremely proud of the resiliency our employees and partners have shown to reach this milestone, which brings FastWave another step closer to FDA clearance," said Scott Nelson, CEO of FastWave Medical (搜索). "I also want to credit FDA and its review team for being very responsive and keeping our submission moving forward. We designed Artero (搜索) to be fast, easy-to-use, and highly deliverable, and we're excited to partner with leading physicians on this IDE trial."
Clinical Development Context
The IDE approval follows a first-in-human study of FastWave's Artero (搜索) platform and a 30-patient feasibility study of its Sola (搜索) laser-based coronary IVL system. FastWave was named one of Fierce Medtech's "Fierce 15" companies and MD+DI's 2025 Medtech Company of the Year, and recently expanded its international IVL patent portfolio.
Company Background
FastWave Medical (搜索) pioneers next-generation IVL technology to transform the treatment of calcific artery disease in peripheral and coronary applications. Founded in 2021 by industry veterans with deep startup and multinational medical device experience, FastWave has secured over $50 million in venture funding to advance its dual-platform IVL systems.
The company's technologies address key limitations in current calcium-modification devices by improving deliverability, energy output, and usability, eliminating extra procedural steps while maintaining the simplicity and safety that has driven IVL's rapid clinical adoption.