FastWave Medical's new laser IVL system shows 96.4% success in first-in-human study

FastWave Medical has reported positive interim results from the first-in-human (FIH) feasibility study of its Sola™ coronary laser intravascular lithotripsy (L-IVL) system for treating calcified coronary artery disease. Thirty patients with calcified coronary arteries participated in the study across two clinical sites.

The study found that the Sola™ system achieved 96.4% procedural success in 28 patients undergoing stent implantation. No device-related serious adverse events were reported within 30 days post-procedure. Procedural success was defined as successful stent implantation with a final residual stenosis of less than 50%.

Intravascular imaging revealed calcium fracture in all 30 treated lesions. The mean minimum lumen area increased by 49% following IVL treatment and prior to stent implantation, indicating calcium modification that facilitates vessel expansion.

Scott Nelson, CEO of FastWave Medical, expressed optimism about the findings. "These findings give us confidence as we continue to advance Sola™ toward a future coronary IDE trial," he stated. Dr. Arthur Lee, who performed cases in the study, also noted the system's deliverability and speed.

The Sola™ system is investigational and not available for sale. FastWave Medical is also developing the Artero™ system for peripheral artery disease and has received FDA approval to initiate a pivotal trial for that device.