Stentless Percutaneous Deep Venous Arterialization Using the Boomerang® System

Purpose: To evaluate the early safety and efficacy of the Boomerang® System for percutaneous deep venous arterialization (pDVA) in patients with no-option chronic limb-threatening ischemia (CLTI).

Materials and Methods: A prospective, single-arm feasibility study was conducted at one center. Adults with Rutherford class 5–6 CLTI and no revascularization options underwent pDVA with the Boomerang® system, adapted from the Ellipsys® system to create a tibial artery–to–vein side-to-side anastomosis. Pre-procedure duplex ultrasound (DUS) and CT angiography assessed inflow and venous anatomy. Primary endpoints were technical success, procedural success, and 6-month amputation-free survival (AFS). Secondary endpoints included conduit patency, , wound ischemia and foot infection (WIfI) scores and quality of life (QoL).


Results: Of 26 patients screened, 11 underwent pDVA (mean age 71 ± 7.7 years; 91% male; 91% diabetic; all Hispanic/Latino). Technical success was achieved in 100% (11/11) and procedural success in 91% (10/11). 6-month Kaplan-Meier analysis of AFS was 82% and cumulative conduit patency was 25%. Wound healing occurred in 63% (7/11) at 6 Months with a significant 79.5 % (p=0.010) improvement in WIfI scores. QoL improved at both 3 and 6 months. Secondary interventions were performed in 73% (8/11) of patients. Ten adverse events occurred, including two below-knee amputations; no device-related events were reported.


Conclusion: The Boomerang® Catheter enabled safe, and effective pDVA in no-option CLTI, achieving high technical success, meaningful wound healing, and AFS. These findings support further multicenter studies to validate long-term clinical benefit.