Patients with femoropopliteal disease have distal, superficial arterial lesions. They have to undergo endovascular surgery with grafts. BioMimics 3D Vascular Stent System is one such implant for symptomatic patients with peripheral arterial disease. This study reports the effectiveness and safety outcomes of the graft through 2 years.
The study assessed 271 patients, with de novo lesions, from 43 centers in the USA, Japan, and Germany. The nitinol 3D BioMimics imparted helical shape to the arterial segment. The mean lesion length of the participants was in the range of 42.8 mm to 119.6 mm. There were 30% of patients with total occlusions, while 45.9% had moderate-severe calcification. The team compared the objective performance goals(OPG) of VIVA Physicians with safety and effectiveness endpoints at one year. The study reported the outcomes through 2 years.
182 of 249 patients met primary stent patency at one year and exceeded OPG of 66%. 268 of 269 patients were free from major adverse events (MAE) for 30 days, exceeding 88% OPG. Kaplan-Meier, MAE, and target lesion revascularization freedom estimates at one year were 83.1%, 86.9%, and 88%. After 24 months, they were 70.2%, 79.2%, and 83% respectively. 88.2% patients had improvements >= 1 in Rutherford category. The ankle-brachial index > 0.9 was 64.4% compared to baselines 11.3%.
The BioMimics System was safe and effective through the 24 months. There were no stent fractures, and this treatment is beneficial for patients with femoropopliteal lesions.
Ref: https://journals.sagepub.com/doi/full/10.1177/1526602820980419
