'All-Comers' Trial Finds Increased Risk Of Thrombosis With Abbott's Absorb BVS Stent
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.
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The first quarter of 2018 brought 90 approvals from outside the US, including 56 in Europe, according to Medtech Insight's Approvals Tracker. The biggest category of approvals was cardiovascular, with several new drug-eluting stents and heart-valves coming through during the first three months of the year. Check out our infographic spotlighting the Q1 trends.
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.
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.