FastWave Medical has received US Food and Drug Administration (FDA) approval of its investigational device exemption (IDE) application, which clears the company to begin a US pivotal trial of its Artero electric intravascular lithotripsy (IVL) system for the treatment of peripheral artery disease (PAD).
The SPARC trial will enrol up to 125 patients across 30 investigational sites and will evaluate the safety and effectiveness of Artero in treating calcified peripheral lesions. The study will be led by co-principal investigators Sahil Parikh, director of Endovascular Services at Columbia University Irving Medical Center in New York, USA, and Venita Chandra, clinical professor of surgery at Stanford Health Care in Stanford, USA.
“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, chief operations operator (COO) of FastWave Medical. “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.”
According to FastWave Medical, Artero delivers circumferential sonic pressure waves at 4Hz, up to four times 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 US FDA clearance,” said Scott Nelson, chief executive officer (CEO) of FastWave Medical. “I also want to credit the US FDA and its review team for being very responsive and keeping our submission moving forward. We designed Artero to be fast, easy-to-use, and highly deliverable, and we’re excited to partner with leading physicians on this IDE trial.”
The IDE approval follows a first-in-human study of FastWave’s Artero platform and a 30-patient feasibility study of its Sola laser-based coronary IVL system.
