FastWave Medical Achieves Major Milestones in Coronary Laser IVL Research and Patenting

FastWave Medical has marked significant strides in advancing its coronary laser intravascular lithotripsy (L-IVL) platform, achieving two major milestones: the completion of patient enrollment in its 30-patient coronary feasibility study and securing its ninth U.S. patent.

This crucial feasibility study is designed to assess the safety and performance of Sola™, FastWave's innovative L-IVL system, specifically for patients grappling with intricate cases of calcified coronary artery disease. The data gathered during the study will undergo an independent analysis by a core laboratory, ensuring that the findings are unbiased and reflect the technology's true potential.

“Completing enrollment in this study highlights our commitment to innovation and our focus on delivering effective solutions for complex cardiovascular diseases,” said Scott Nelson, the CEO of FastWave Medical. “The advancements we have made in our technology and clinical trials move us forward in addressing the pressing needs faced by physicians treating coronary artery disease (CAD).”

Coronary artery disease represents one of the foremost causes of mortality worldwide, accounting for over 370,000 deaths annually in the U.S. alone, as per CDC data. The potential risk posed by calcified plaque complicates treatment options significantly. Specifically, this hardened plaque can render arteries less flexible and hinder the success of stent placements, thereby complicating interventions that could potentially save lives.

FastWave Medical's new patent enhances its intellectual property portfolio, indicating the company's continuous efforts to innovate in medical technology. The recognition of their L-IVL system as a pioneering tool signals its promise toward reshaping how medical professionals can approach treatment for calcified coronary disease.

“We are just beginning to uncover the possibilities with coronary IVL,” noted Trent Mengel, Head of Clinical at FastWave Medical. The conclusion of enrollment in the feasibility study underscores the escalating trust and enthusiasm among clinical partners regarding the future of laser-based IVL technology.

The feasibility study comes on the heels of FastWave's recent presentation of invaluable first-in-human and pre-clinical findings at TCT 2025 (Transcatheter Cardiovascular Therapeutics). These findings spotlight the Sola™ system's capacity to enhance vessel preparation and overall procedural outcomes for individuals with complex calcified lesions.

Dr. Arthur Lee, Director of Vascular Services at The Cardiac Vascular Institute (TCAVI), and a key investigator in the study remarked, “Sola™ has demonstrated consistently reliable energy delivery and efficient calcium modification, even in challenging anatomical structures.” He further emphasized the connection between pre-clinical research and tangible, positive results observed in clinical applications.

FastWave Medical, founded in 2021 by a group of industry veterans, continues to progress towards larger-scale clinical trials aimed at evaluating its advanced IVL system. With over $50 million in venture funding, the company is dedicated to transforming the treatment landscape for patients with complex cardiovascular issues by introducing a dual-platform IVL system that eliminates existing barriers while enhancing usability and delivery efficiency.

Their continual advancements seek to address the limitations of current calcium-modification devices, aiming to provide physicians with more reliable tools for treatment success. To discover more about their innovative efforts and technology, visit their official website at fastwavemedical.com.