B. Braun's Multi-Loc Multiple Stent Delivery System Evaluated to Treat Femoropopliteal Lesions
September 6, 2017—A report of 6-month outcomes from the first clinical experience with the Multi-Loc multiple stent delivery system (B. Braun Melsungen AG) for focal stenting in long femoropopliteal lesions was published by Klaus Amendt, MD, et al online in Vasa: European Journal of Vascular Medicine.
As summarized in Vasa, the primary endpoint of the observational, multicenter LOCOMOTIVE study was the rate of target lesion revascularization (TLR) at 6 months. In the study, femoropopliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow-limiting dissections, elastic recoil, or recoil caused by calcification required stenting, investigators implanted up to six short stents per delivery device, each 13 mm in length. Sonographic follow-ups and clinical assessments were scheduled at 6 months.
The investigators reported that a total of 75 patients aged 72.9 ± 9.2 years were enrolled. Of the 176 individually treated lesions,134 (76.2%) were in the superficial femoral artery; the rate of TASC C/D lesions was 51.1% (90/176). The total lesion length was 14.5 ± 9.0 cm, with a reference vessel diameter of 5.6 ± 0.7 mm. Overall, 47% ± 18% of lesion lengths could be saved from stenting.
At 6 months, the patency rate was 90.7% (68/75) and the all-cause TLR rate was 5.3% (4/75) in the overall cohort.
The first clinical experience at 6 months suggests that treatment with the Multi-Loc multiple stent delivery system was safe and effective to treat femoropopliteal lesions of considerable length (14.5 ± 9.0 cm). Almost half of the lesion length could be saved from stenting, patency was high, and TLR rates were acceptably low, concluded the LOCOMOTIVE investigators in Vasa.