Limflow, developer of the Limflow System for treatment of Chronic Limb-Threatening Ischemia (CLTI), partnered with NAMSA during this pertinent clinical study. With a dedicated focus on medical device and IVD products, NAMSA has designed and conducted trials in every area of the world to address wide-ranging client objectives. Our clinical experts are uniquely positioned to understand what each client is up against, taking best practices and proven strategies from previous programs and applying them to evolving regulatory requirements for their specific study.
BACKGROUND
Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation.
METHODS
[LimFlow] conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from aboveankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure.
RESULTS
[LimFlow] enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan–Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported.
CONCLUSIONS
[LimFlow] found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options.
Anney Peterson
Anney Peterson is the Senior Marketing Operations Specialist at NAMSA, focusing on expanding the overall knowledge and understanding in the MedTech industry. She obtained a BBA in Marketing from the University of Toledo (Ohio) as well as an A.S. in Psychology from Monroe County Community College (Michigan).