Summary: First-in-Human Study of Novel Coronary Laser IVL System (Sola) by FastWave Medical.
Summary: First-in-Human Study of Novel Coronary Laser IVL System (Sola) by FastWave Medical.
Source: Sola™ Coronary Laser IVL Feasibility Study, – IRB Approved 2025
1. Technology Overview:
FastWave Medical has initiated clinical evaluation of a new laser-based intravascular lithotripsy (IVL) system, named Sola™, designed to modify calcified coronary artery lesions more safely and effectively.
2. Device Design:
• Sola™ is a rupture-resistant balloon catheter that emits 360° pressure pulses using laser energy.
• Developed to improve on existing IVL technologies by enhancing crossability, energy precision, and ease of use—eliminating extra procedural steps.
3. Study Details:
• A first-in-human, multicenter feasibility study was launched under Institutional Review Board (IRB) approval on May 7, 2025.
• The study evaluates safety, lesion crossing success, and initial performance outcomes in patients with moderate to severe coronary artery calcification.
4. Early Clinical Results:
• 100% procedural success in crossing target lesions.
• No major adverse events reported within 30 days.
• Device showed exceptional deliverability, particularly in complex and tortuous anatomy.
• Operates at a 5 Hz pulse frequency, reducing ischemic time—especially valuable in patients with reduced cardiac output.
5. Clinical Relevance:
• Laser IVL represents a less traumatic alternative to high-pressure balloon angioplasty or rotational atherectomy.
• Offers improved lesion preparation for stent delivery in heavily calcified arteries.
6. Next Steps:
• The data will be used to support regulatory submissions and guide the design of a pivotal U.S. clinical trial for FDA clearance.
• FastWave enters the competitive IVL market alongside established technologies such as Shockwave.
Scientific Reference:
Sola™ Coronary Laser IVL Feasibility Study
• IRB Approval: May 7, 2025
• Study Design: Multicenter, first-in-human safety and performance study
• Clinical Milestone: 100% lesion crossing success, no 30-day MACE
• Planned Next Phase: U.S. pivotal trial for regulatory approval
https://citoday.com/news/fastwave-begins-fih-feasibility-study-of-sola-coronary-laser-ivl-system-1