Abbott has presented positive long-term data from a two-stage, prospective and non-randomised trial investigating the Absorb drug-eluting bioresorbable vascular scaffold as a treatment for coronary artery disease.
The device, which is made of polylactide, restores blood flow by opening a blocked vessel and providing support to it.
Five-year results from the first stage reported no cardiac deaths, blood clots (thromboses) or ischaemia-driven target lesion revascularisation.
The two-year data from the second stage Absorb trial reported a MACE rate of 6.8% and a low late loss of 0.27mm in 44 patients.
Primary endpoints of the study include MACE and treated-site thrombosis rates – at 30 days and at six, nine, 12 and 24 months, imaging assessments by angiography, intravascular ultrasound, optical coherence tomography, and other imaging modalities at six, 12, 18, 24, 36 and 60 months.
The study’s principle investigator Patrick Serruys said the study suggests that Absorb could provide long-term benefits for patients with coronary artery disease.
Abbott Vascular chief medical officer Charles Simonton said the company is planning to conduct a number of additional clinical trials for Absorb in 2012 to further build the clinical evidence supporting the device.