We are very proud to share this article, published in the CVIR Endovascular journal by Prof. J. Tessarek and Prof. R. Kolvenbach:
Safety and Effectiveness of BYCROSS rotational atherectomy and aspiration device: A prospective, multi‑center pre‑market approval study.
The study results: The acute procedural success was achieved in 39/41 (95.12%) lesions, partially without wire guidance (11/41 (26.82%)). No embolic protection was used, and adjunctive angioplasty and stenting was performed in 40/41 (97.56%)
and 12/41 (29.26%) lesions, respectively without device related MAE’s at 30 days. Mean level of stenosis was 5.7% at discharge and 21.7% at 6 months FU measured by DUS. Mean ABPI was 0.8, 1.0 and 0.8 at baseline, discharge, and 6 months FU respectively.