Preventing major amputations and preserving functional limbs in no option critical limb-threating ischemia patients

Abstract Aveera Medical aims to reduce major amputations, improve patient quality of life, and increase access to treatment opportunities for no-option Chronic Limb-Threatening Ischemia (NO-CLTI) patients through their novel native Deep Vein Arterialization (nDVA) procedure using the Boomerang System. CLTI is the most severe form of Peripheral Artery Disease, a progressive condition in which atherosclerotic plaques build up inside a patient’s arteries and slowly reduce the blood supply to the extremities, leading to painful ischemia, tissue death, and ultimately amputation. Many of these patients are told by their medical providers that they have “no option” for traditional therapy to restore blood flow to their feet and are resigned to accept amputation of their leg. CLTI disproportionately affects underserved populations; rates of CLTI in socioeconomically disadvantaged areas are higher, women are more likely than men to have above the knee amputations, and black patients are 4x more likely to have severe amputations. Recently, a technique for treating NO-CLTI was FDA approved, but this therapy requires implanting long, polymer-coated stents in the leg. This stented approach is associated with many adverse events and can only be performed in hospital settings, limiting patient access to care. In contrast, nDVA is simpler and involves creating an anastomosis between a patient’s tibial artery and an adjacent paired vein, allowing blood to flow into the vein and be directed to the foot. Aveera Medical has already completed both a first in human and early feasibility study in humans which demonstrated the procedure can improve the rate of limb salvage in no-option CLTI patients by as much as 50%, which could correspond to 60,000 fewer amputations annually in the U.S. These promising clinical outcomes demonstrate the potential for this technology and procedure to provide a better option for patients who previously had no alternative except to wait for an impending major amputation. This Phase II SBIR is focused on the completion of a pivotal, multi-center, Investigational Device Exemption trial in the U.S. that was granted full approval by the FDA in February 2024 to demonstrate the safety and effectiveness of this therapy in support of an application for FDA market clearance. In this clinical trial, 120 patients with NO-CLTI will be enrolled across up to 20 sites. A tibial artery to tibial vein anastomosis will be created to facilitate deep venous arterialization. The primary endpoint is amputation-free survival, documented at 6 months post-procedure. Secondary endpoints will include technical success of catheter deployment, procedure success, limb salvage, primary patency, primary assisted patency, secondary patency, target wound healing, and complete wound healing, evaluated at multiple timepoints up to 6 months post- procedure. The successful conclusion of the pivotal trial will supply Aveera Medical with the data necessary for FDA submission and development of reimbursement coding and coverage. These steps are vital in providing NO-CLTI patients with a new option in their care plans, bringing about a revolutionary shift in their treatment and significantly improving the quality of life by relieving rest pain and preventing major amputation.