The U.S. pivotal study will evaluate FastWave’s electric IVL system in patients with peripheral artery disease. MINNEAPOLIS, Aug. 11, 2026 /PRNewswire/ — FastWave Medical, which is developing next-generation intravascular lithotripsy (IVL) technology, has received FDA approval of its Investigational Device Exemption (IDE) application, which clears the company to begin a U.S. pivotal trial of its ArteroTM electric IVL […]
Tag: FastWave
FastWave Medical Secures Four New International Patents
Newly issued patents in Australia and Japan cover the company’s Artero™ E-IVL and Sola™ L-IVL platforms as FastWave advances toward peripheral and coronary IDE trials. MINNEAPOLIS, May 19, 2026 /PRNewswire/ — FastWave Medical has added four international patents to its intellectual…
FastWave Medical Completes Enrollment in Coronary Laser IVL Feasibility Study and Secures Ninth U.S. Patent
Successful study enrollment and patent issuance highlight FastWave’s continued momentum with its Sola™ coronary laser intravascular lithotripsy platform. MINNEAPOLIS, Nov. 11, 2025 /PRNewswire/ — FastWave Medical successfully completed enrollment in its 30-patient coronary feasibility…
FastWave Medical Presents First-in-Human and Pre-Clinical Data for Sola™ Coronary Laser IVL System at TCT 2025
Findings demonstrate safety, procedural success, and imaging-confirmed calcium modification using a next-generation laser intravascular lithotripsy (IVL) platform. MINNEAPOLIS, Oct. 29, 2025 /PRNewswire/ — FastWave Medical presented new first-in-human (FIH) and pre-clinical data for its…
FastWave Medical Names Leading Vascular Specialists as Principal Investigators for Peripheral IVL Trial
Renowned endovascular specialists from Columbia and Stanford to guide pivotal trial of Artero™ electric IVL system. MINNEAPOLIS, Sept. 30, 2025 /PRNewswire/ — FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, today announced the appointment of its principal…
FastWave Medical Announces Successful First-in-Human Procedures in Study of Sola™, Its Next-Generation Coronary Laser IVL System
Initial FIH procedures launch FastWave’s multi-center feasibility study evaluating the safety and performance of its laser-based coronary IVL platform. MINNEAPOLIS, June 3, 2025 /PRNewswire/ — FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, today announced the…
FastWave Medical Receives IRB Approval for SolaTM, its Novel Coronary Laser IVL (L-IVL) System
Feasibility study for coronary artery disease will commence ahead of FastWave’s expected U.S. pivotal trial. MINNEAPOLIS, May 7, 2025 — FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, has secured Institutional Review Board (IRB) approval to commence a coronary feasibility study utilizing SolaTM, its novel laser IVL (L-IVL) […]



