FastWave Medical has received Institutional Review Board (IRB) approval to initiate a coronary feasibility study for its innovative Sola™ laser intravascular lithotripsy (L-IVL) system. This marks a major milestone for the company as it prepares for a pivotal U.S. trial in collaboration with Clinical Accelerator. The study aims to evaluate the safety and effectiveness of Sola™ in treating calcified coronary artery disease—a condition that often complicates interventional cardiology procedures and affects patient outcomes.

The Sola™ L-IVL platform is a next-generation system that combines a laser-based energy source with a rupture-resistant balloon catheter. Unlike traditional IVL devices, Sola™ produces precise, circumferential sonic pressure waves that allow physicians to effectively modify hardened calcium deposits with improved consistency and control. This technology is designed to enhance procedural safety and reduce complications in complex coronary interventions. Physicians and clinical experts have highlighted its user-friendly design and the potential to significantly improve treatment precision for calcified arterial lesions.

In addition to its work in coronary disease, FastWave Medical is preparing to launch a U.S. Investigational Device Exemption (IDE) pivotal trial for its Artero™ electric IVL (E-IVL) system targeting peripheral artery disease. The company’s dual development of both coronary and peripheral IVL platforms positions it as a key innovator in the endovascular space. With growing enthusiasm among interventional cardiologists and vascular specialists, FastWave aims to expand the range of therapeutic options for patients with advanced arterial calcification and deliver more personalized and effective vascular care.

MedTech Spectrum's Summary

IRB Approval for Coronary Study: FastWave Medical has secured Institutional Review Board (IRB) approval to begin a coronary feasibility study for its Sola™ laser intravascular lithotripsy (L-IVL) system, a key step toward its upcoming U.S. pivotal trial.

Sola™ L-IVL System Innovation: The Sola™ system features a precision laser energy source and rupture-resistant balloon catheter, enabling safe, effective calcium modification in arteries with enhanced control and consistency.

Expansion to Peripheral Artery Disease: FastWave is also preparing for a U.S. Investigational Device Exemption (IDE) pivotal trial for its Artero™ electric IVL (E-IVL) system, targeting peripheral artery disease and expanding its impact in vascular care.