Avis De Sécurité sur Biodegradable vascular support systems (BVS) Absorb and Absorb GT1

Field Safety Notice

2017-03-31

Slovenia

AMPMDRS

Abbott vascular is seeking, together with european regulatory agencies, (competent and notified bodies) and the professional medical community, additional factual evidence for the absorb and absorb gt1 biodegradable vascular support systems (bvs) in the european market. we will achieve this through registries in collaboration with the community of our key physicians. the registers will cover the implantation of all sizes of absorb and absorb gt1 biodegradable vascular system (bvs) systems in the european market.   from may 31, 2017, the device will only be available for use within the clinical registry at selected hospitals / institutions, which will play a key role in monitoring this technology until summer 2018 when we review the situation. restricting use to these registers will allow the systematic collection of data to answer questions posed at a recent congress, three-year clinical data, and an analysis of the use of absorb ii on the incidence of abdominal thrombosis and the optimal duration of dapt implantation. this will help us show the impact on clinical outcomes following changes in implant technology. we have taken these important restrictive measures in light of recent questions about the increased incidence of serious adverse cardiac events, notably myocardial infarction and abdominal thrombosis, while we await further data to determine if improved implantation techniques will mitigate this increased incidence of events and evaluate the longer-term benefits associated with using absorb.   as we continue to use bvs absorb and absorb gt1 systems over the past few years, we have gathered clinical evidence to support implant techniques that provide optimal clinical outcomes. key knowledge from this experience includes the importance of an appropriate implantation technique that you can express with the abbreviation psp (prepare the vessel, size appropriately, post-dilate - prepare the vessel, select the appropriate size, dilate according to the procedure). recent analysis data, such as those conducted in the european ghost-eu1 registry, four cities2 and in studies provided by sponsored by abbott3, emphasize the importance of implantation techniques in optimizing short- and long-term outcomes. the frequency of events recently reported from the use of absorb systems in actual studies in europe, such as that conducted by dr. tanaka4 et al. brugaletta1, is consistent with the incidence of events with a number of currently approved state-of-the-art drug-excreting metal stents (des). 1 psp analysis on ghost eu - impact of technique on clinical outcomes - s. brugaletta - tct 2016 2 gori, t. 4 cities registry, europcr 2015 3 psp analysis - impact of procedural technique on long term adverse outcomes in the absorb trials - a first look - s. ellis - tct 2016 4 tanaka a, latib a, kawamoto h, jabbour rj, sato k, miyazaaki t, naganuma t, magieri a, pagnesi m, montalto c, cheiffo a, carlino m, montorfano m, colombo a. clinical outcomes of a real world cohort following bioresorbable vascular scaffold implantation utilizing an optimized implantation strategy. eurointervention 2016: jaa-004 2016, doi10422 / eij-d-16-00247 5 psp analysis - impact of procedural technique on long term adverse outcomes in the absorb trials - a first look - s. ellis - tct 2016 6 gori, t. 4 cities registry, europcr 2015 7 everolimus-eluting bioresorbable vascular scaffolds in patients with coronary artery disease: the absorb iii trial - g. stone - tct 2015 8 absorb iv trial - g. stone - jim 2017 in addition, treatment of veins with a reference diameter (rvd) greater than 2.50 mm (greater than 2.25 mm when measured by qca) has been shown to reduce the incidence of st events to a level comparable to xience.5. 6.7 finally, data from the absorb iv8 trial, the most recent randomized controlled trial in the absorb trial group, showed preliminary st events (in the blinded analysis of the data collected) that were less than the analysis of the collected data in the 30 days absorb iii trial. and interim data after 1 year. these data also confirm the importance of avoiding very small vessels and dilatation following the procedure as factors that may contribute to the reduction of st frequency.