Tag: FastWave

FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System

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 […]

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) […]