Abbott To Restrict Absorb To Registries In Europe For At Least A Year
A letter to Abbott's customers states that the company will restrict its Absorb bioresorbable stent to registries in Europe while it investigates possible safety issues flagged in clinical trials.
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Abbott is giving up on selling its first-generation biosorbable coronary stent, which failed to match the performance of contemporary metallic drug-eluting stents in clinical trials. The company says it will continue working on the next-generation biosorbable stents and continue the ongoing trials of Absorb GT1 BVS.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. Over the last month, 31 new trials started, 25 trial were completed, one trial was "reinitiated," and six trials were terminated or suspended, according to meddevicetracker.
Preliminary two-year results from the randomized AIDA trial comparing Abbott's Absorb GT1 BVS and Abbott's Xience Prime drug-eluting stent found patients treated with Absorb were almost four times as likely to develop a stent thrombosis. The results are the latest in disappointing clinical news for the bioabsorbable scaffold.