FastWave Medical Unveils Breakthrough Data for Sola™ Coronary Laser IVL System at TCT 2025
FastWave Medical made headlines at the TCT 2025 conference by presenting promising first-in-human (FIH) data alongside pre-clinical research for their groundbreaking Sola™ coronary laser intravascular lithotripsy (L-IVL) system. This next-generation technology aims to tackle complex coronary lesions laden with calcium, a significant challenge in interventional cardiovascular procedures.
During this pioneering symposium, recognized as the leading forum in interventional cardiology, the results of FastWave’s FIH study were highlighted as a Featured Innovation, underscoring the platform's safety and procedural success. Specifically, the findings revealed that the Sola™ system performed robustly in nine patients, achieving both safety and efficacy endpoints. Remarkably, there were no major adverse cardiac events (MACE) within the 30-day period following treatment, demonstrating the system’s reliable performance.
Dr. Arthur Lee, a notable figure in vascular services at The Cardiac Vascular Institute and consultant to FastWave Medical, commented on the results, stating, "The Sola™ system demonstrated consistent and effective calcium modification across a range of challenging coronary lesions." He emphasized that these outcomes signify the potential for the Sola™ platform to deliver precise and controllable energy, maintaining the safety and simplicity that clinicians prioritize in existing IVL technologies.
The research further delved into the crucial parameters governing laser energy application, demonstrating how variations in sonic pressure and pulse count influenced calcium modification in calcified arteries. This foundational work, including pre-clinical studies using surrogate and excised vessels, was pivotal in establishing an optimized dosing algorithm for the clinical feasibility study that was part of the FIH assessment. The utilization of advanced imaging techniques such as micro-CT confirmed the Sola™ system's ability to deliver uniform energy distribution, setting a new benchmark in the treatment of calcific disease.
FastWave’s commitment to innovation is bolstered by significant venture funding, exceeding $50 million, aimed at advancing their dual-platform IVL systems. This funding highlights the company’s dedication to addressing existing limitations faced by current calcium-modification devices, enhancing energy output, usability, and overall performance. The Sola™ system's ability to refine treatment methods while reducing procedural complexity positions it as a transformative option for vascular health practitioners.
As FastWave Medical continues to push boundaries in interventional treatments, the forthcoming detailed findings from FastWave’s studies are anticipated to be published in an upcoming supplement of the Journal of the American College of Cardiology (JACC), promising to further enrich the medical community's understanding of this cutting-edge technology. The significant implications of the Sola™ system could herald a new era in the management of calcified coronary lesions, ultimately improving patient outcomes in cardiovascular care.
In summary, FastWave Medical’s Sola™ coronary laser IVL system represents a significant leap in the fight against calcific artery disease, blending innovative technology with clinical efficacy to redefine how complex lesions are treated in patients across the globe. For those interested in the latest developments in this field, further information can be found on FastWave’s official website.
During this pioneering symposium, recognized as the leading forum in interventional cardiology, the results of FastWave’s FIH study were highlighted as a Featured Innovation, underscoring the platform's safety and procedural success. Specifically, the findings revealed that the Sola™ system performed robustly in nine patients, achieving both safety and efficacy endpoints. Remarkably, there were no major adverse cardiac events (MACE) within the 30-day period following treatment, demonstrating the system’s reliable performance.
Dr. Arthur Lee, a notable figure in vascular services at The Cardiac Vascular Institute and consultant to FastWave Medical, commented on the results, stating, "The Sola™ system demonstrated consistent and effective calcium modification across a range of challenging coronary lesions." He emphasized that these outcomes signify the potential for the Sola™ platform to deliver precise and controllable energy, maintaining the safety and simplicity that clinicians prioritize in existing IVL technologies.
The research further delved into the crucial parameters governing laser energy application, demonstrating how variations in sonic pressure and pulse count influenced calcium modification in calcified arteries. This foundational work, including pre-clinical studies using surrogate and excised vessels, was pivotal in establishing an optimized dosing algorithm for the clinical feasibility study that was part of the FIH assessment. The utilization of advanced imaging techniques such as micro-CT confirmed the Sola™ system's ability to deliver uniform energy distribution, setting a new benchmark in the treatment of calcific disease.
FastWave’s commitment to innovation is bolstered by significant venture funding, exceeding $50 million, aimed at advancing their dual-platform IVL systems. This funding highlights the company’s dedication to addressing existing limitations faced by current calcium-modification devices, enhancing energy output, usability, and overall performance. The Sola™ system's ability to refine treatment methods while reducing procedural complexity positions it as a transformative option for vascular health practitioners.
As FastWave Medical continues to push boundaries in interventional treatments, the forthcoming detailed findings from FastWave’s studies are anticipated to be published in an upcoming supplement of the Journal of the American College of Cardiology (JACC), promising to further enrich the medical community's understanding of this cutting-edge technology. The significant implications of the Sola™ system could herald a new era in the management of calcified coronary lesions, ultimately improving patient outcomes in cardiovascular care.
In summary, FastWave Medical’s Sola™ coronary laser IVL system represents a significant leap in the fight against calcific artery disease, blending innovative technology with clinical efficacy to redefine how complex lesions are treated in patients across the globe. For those interested in the latest developments in this field, further information can be found on FastWave’s official website.
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