FastWave Medical today announced new first-in-human and pre-clinical data for its Sola coronary laser intravascular lithotripsy (L-IVL) system.
Minneapolis-based FastWave designed Sola to treat cardiovascular calcium with sleek, rupture-resistant balloon catheters. Its custom laser energy source produces actuating, circumferential sonic pressure waves. Sola enables improved operator control to safely and effectively modify calcium.
FastWave received the go-ahead to conduct the trial earlier this year. In June, it announced the first-in-human use of Sola in the study.
The company shared the findings from this study at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. FastWave’s study evaluated Sola in patients with complex calcified coronary lesions. The first-in-human results demonstrated the safety, efficacy and procedural success of the next-generation system.
Additionally, the company shared an abstract evaluating how laser energy parameters influence sonic pressure and calcium modification. This helped to define the optimal dosing algorithm used in the first-in-human clinical study.
“These early results validate the vision behind Sola,” said Scott Nelson, co-founder and CEO of FastWave Medical. “We set out to design an IVL system that gives physicians greater precision and confidence when treating the most challenging coronary disease. Seeing that translate into consistent procedural success and safety is a clear signal that we’re expanding what’s possible with IVL.”
More on the Sola findings shared by FastWave at TCT 2025
FastWave’s single-arm feasibility study evaluates patients with moderate-to-severe calcified de novo coronary lesions. It takes place across three centers in Tashkent, Uzbekistan, evaluating 30 patients. The study remains ongoing with the company expecting to complete enrollment this year.
Primary endpoints include 30-day major adverse cardiac events (MACE, defined as cardiac death, myocardial infarction or target-vessel revascularization) and procedural success, defined as successful stent delivery with <50% residual stenosis and no in-hospital MACE.
Sola proved both safe and technically successful among the first nine patients, achieving full stent delivery without complications. Analysis showed 100% stent delivery success and zero in-hospital MACE, abrupt closures or flow-limiting dissections. Mean diameter stenosis reduced from 57.1% pre-procedure to 8.6% post-procedure. Intravascular ultrasound (IVUS) imaging confirmed calcium fracture or disruption in all patients.
“The Sola system demonstrated consistent and effective calcium modification across a range of challenging coronary lesions,” said Dr. Arthur Lee, director of vascular services at The Cardiac & Vascular Institute (TCAVI) and consultant to FastWave Medical. “These early results show the potential for FastWave’s laser-based IVL to deliver precise, controllable energy while maintaining the safety and simplicity physicians value in existing IVL platforms.”
More on the pre-clinical insights shared by the company
FastWave said its translational research program looked at how variations in sonic pressure magnitude and pulse count influence calcium modification in surrogate and excised calcified vessels.
Researchers used micro-CT imaging. They found that higher sonic pressure produced greater calcium fracture regardless of pulse count. Calcium modification also proved comparable at 100 atm and 150 atm, establishing 100 atm as the optimal therapeutic setting.
Findings confirmed that FastWave’s actuating, single-emitter design produces consistent 360-degree energy delivery. The company said it validated the dosing algorithm implemented in the first-in-human study. The system’s rupture-resistant balloon delivers 360-degree energy with each pulse. Its 5 Hz pulse rate enables efficient therapy while reducing ischemic time. Imaging confirmed calcium fracture, improved luminal expansion, and full stent apposition, even in nodular calcification.
FastWave plans for the data shared at TCT to guide its regulatory strategy and the design of a pivotal study expected to begin in 2026. It said these findings mark “a key step toward future FDA approval.”
