DynamX Bioadaptor, a novel 'uncaging' platform for coronary artery revascularisation

June 25, 2020

Drug Eluting Stents (DES) are the mainstay of coronary artery disease treatment. Although DES design iterations have reduced MACE in the first year after PCI, beyond 1-year, a persistent 2-3% annualized event rate without plateau is observed. The DynamX™ Novolimus-Eluting Coronary Bioadaptor System is a 71 micron thin, cobalt-chromium platform with a novel "uncaging" mechanism of the circumferential rings after 6 months while maintaining axial links following uncaging.

Conventional metallic DES "cage" the coronary artery, cause geometric distortion and inhibit positive adaptive remodeling and vasomotion. These factors likely contribute to the persistent annual MACE rate after PCI. The DynamX Bioadaptor combines acute performance of contemporary DES and unique benefits of arterial "uncaging" within 6 months, with restoration of normal geometry, compliance and positive adaptive remodeling. The device was evaluated in a mechanistic clinical study which enrolled 50 patients. Multiple clinical endpoints including device/ procedure success and target lesion failure (TLF) at 6, 9 and 12 months were assessed with clinical follow-up continuing annually through 3 years. Multimodality imaging endpoint analyses using QCA and IVUS were performed at baseline and at 9 or 12 months in subgroups. OCT imaging was performed in a subset of patients at the 9 or 12 month time point. Observed an acute lumen gain of 1.63 ± 0.34 mm with low late lumen loss (0.12 ± 0.18 mm) by QCA. IVUS imaging showed the unique feature conferred by vessel uncaging which allowed for the vessel to undergo positive adaptive remodeling to maintain lumen area for good blood flow, a characteristic not observed with metallic stents. Clinical data showed no Target Vessel Revascularization (TVR) or Definite/Probable device thrombosis through 12 months. The DynamX Bioadaptor combines the acute performance of contemporary DES with the unique benefit of arterial "uncaging" to permit a return towards normal vessel function along with compensatory positive adaptive remodelling which may result in fewer clinical events beyond one year. This fundamental innovation in device design allows the bioadaptor to match current DES in acute performance while showing the promise of mitigating the 2-3% annualized event rates beyond year 1.
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