FastWave Medical has completed the initial first-in-human procedures in the multicentre feasibility study of the Sola coronary laser intravascular lithotripsy (IVL) system.
The study is designed to evaluate the performance and safety of Sola in individuals with calcified coronary artery disease.
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According to the company, this rupture-resistant balloon catheter allows physicians to treat hardened calcium in blood vessels with control and precision.
The system’s laser energy claims to deliver a 360-degree pressure with every pulse, ensuring therapeutic consistency even in challenging lesions.
Each energy pulse of the system delivers circumferential sonic pressure to any lesion for multidirectional, predictable performance.
This latest development follows the company’s first-in-human study of its peripheral electric IVL system, Artero, which demonstrated a complete procedural success rate without any adverse events observed at a 30-day follow-up.
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By GlobalDataThe findings from the Sola study are expected to inform the company’s regulatory submissions and the design of its pivotal US trial, paving the way for obtaining approval from the Food and Drug Administration (FDA).
FastWave Medical technology head Sukanya Iyer said: “Our team set out to reimagine what’s possible with coronary IVL.
“Seeing Sola perform in human cases reinforces our commitment to give clinicians cutting-edge tools for their high-risk patients.”
FastWave focuses on next-generation IVL technology, aiming at treating calcific artery disease in both peripheral and coronary applications.
It has raised over $40m in venture financing to progress its dual-platform IVL systems.
FastWave Medical COO Tristan Tieso said: “Every step of developing Sola has focused on solving the real-world problems physicians face in treating complex arterial disease.”
Last month, the Institutional Review Board granted approval for the company to commence the coronary feasibility study using Sola.
