#USA #Minneapolis #FastWave Medical #Sola IVL #coronary artery

FastWave Medical Reports Groundbreaking Results in Coronary Laser IVL Study

FastWave Medical, a pioneer in next-generation intravascular lithotripsy technology, has recently announced striking interim results from its first-in-human feasibility study of the Sola™ coronary laser IVL (L-IVL) system. The study involved thirty patients treated across two clinical sites, and the initial outcomes are painting a promising picture for future applications in the management of calcified coronary artery disease.

The study's highlights indicate a significant procedural success rate of 96.4%, with stent delivery successfully achieved in 28 out of 30 cases, showcasing the system's effectiveness. Importantly, no serious adverse events related to the Sola™ system were reported in the 30 days following the procedures, marking a safe and successful initial experience.

Study Insights

Patients in the trial presented substantial baseline challenges, characterized by an average stenosis of 79.1%. However, following the Sola™ laser IVL treatment, this dropped dramatically to 12.1%. Additionally, physicians reported a remarkable average gain of 49% in minimum lumen area before stenting. Intravascular imaging assessments revealed that all treated lesions exhibited calcium fractures, which is essential for effective stent placement and better long-term outcomes.

The Sola™ IVL system’s design features a low-profile catheter with a single optical emitter and a physician-controlled translating emitter that allows for energy delivery along the length of the target lesion. This innovative technology can reportedly deliver five pulses of energy faster than traditional methods, creating circumferential acoustic pressure with each pulse. This design is central not only to achieving procedural success but also in enhancing the overall experience for medical professionals and patients alike.

Scott Nelson, CEO of FastWave Medical, expressed optimism regarding the findings: "These interim results are encouraging, particularly the consistency of calcium fracture and luminal gain we observed before stent implantation. The findings give us confidence as we move forward with Sola™ in anticipation of a future coronary IDE trial."

Arthur Lee, MD, FACC, who was directly involved in the study, emphasized the system's deliverability and control features, noting, "The ability to translate the optical emitter provides a differentiated way to direct lithotripsy along the lesion, while the rapid energy delivery is very encouraging."

Future Implications

These results are part of a broader effort by FastWave Medical to revolutionize the treatment of calcific artery disease. With the successful interim data from this coronary trial, they aim to build on the momentum gained from their peripheral IVL platform, which recently received FDA IDE approval for an upcoming pivotal trial. FastWave has also made headlines by being recognized as one of Fierce Medtech's