Twelve-month clinical and imaging outcomes of the uncaging DynamX Bioadaptor System.

Aims We assessed the safety and efficacy of the DynamX™ Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements. Methods and results This multi-center study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.61±0.34 mm, and device and procedure success was 100%. Through 12 months, two target lesion failures occurred, both were cardiac deaths (day 255 and 267 post-procedure). No definite or probable device thrombosis was observed. Mean late lumen loss was 0.12±0.18 mm in-device and 0.11±0.16 mm in-segment. Per intravascular ultrasound, the mean device area and mean vessel area increased significantly by 5% and 3%, respectively, while the mean lumen area was maintained. Stationary optical coherence tomography in seven patients demonstrated restoration of cyclic pulsatility with an approximate lumen area variance of 11% between systole and diastole. Conclusions The DynamX bioadaptor showed drug-eluting stent-like acute performance and safety and efficacy through one year. Positive remodelling with an increase of vessel and device area while maintaining the mean lumen area was demonstrated. Long-term follow-up and randomized trials are required to assess the benefit of this device on events beyond one year.