Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment
Thursday, June 30, 2022
Reflow Medical, Inc., a medical device company based in California, has successfully completed the enrollment phase of the DEEPER LIMUS clinical trial (NCT04162418). The trial aims to evaluate the effectiveness of the Temporary Spur Stent System, a patented device designed specifically for the treatment of long, diffuse, and severely calcified infrapopliteal disease. By allowing for uniform expansion of the stent, the system maximizes the diameter of the vessel lumen, potentially reducing acute vessel recoil and dissections.
The Temporary Spur Stent System addresses the unmet clinical need in treating patients suffering from Critical Limb Ischemia (CLI). It consists of a unique nitinol stent system with radially expandable spikes or "spurs" that create channels for enhanced uptake of antiproliferative drugs ("limus"-based) into the vessel wall. Importantly, the system is designed to be easily recaptured and removed without leaving anything behind.
Dr. Marianne Brodmann, a Professor and Vascular Specialist at the Medical University of Graz, Austria, and the Principal Investigator for the study, expressed her impression with the acute luminal gain achieved using the Temporary Spur Stent System. She highlighted the positive response of the vessels and emphasized the device's intuitive and user-friendly nature.
Teo Jimenez, Reflow Medical's Senior Vice President of Research and Development, emphasized the versatility and safety of the Spur device with multiple drug-coated platforms, highlighting the completion of enrollment as a significant milestone.
Reflow Medical's CEO and Co-founder, Isa Rizk, expressed gratitude for the partnership with Dr. Brodmann and her team, recognizing their commitment and dedication to advancing technologies in the field of CLI. He acknowledged their remarkable achievement in conducting the study amid a global pandemic, further underscoring their commitment to improving treatment options for CLI patients.