FDA Briefing Docs Appear Positive For Abbott's Absorb, But Adverse Events Highlighted
This article was originally published in The Gray Sheet
An FDA panel meets March 15 to discuss Abbott's PMA for the firm's fully absorbable Absorb scaffold. Pre-meeting materials give a generally positive view of the device, but they highlight some elevated adverse-event rates.
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The US Market for interventional cardiology products, which includes diagnostic and therapeutic products, is anticipated to expand from an estimated $3.3 billion in 2015 to roughly $3.6 billion in total product sales by the year 2020. One bright spot in this otherwise lackluster market is the interventional diagnostic products segment, which is projected to grow at CAGR of 4.7% and reach almost $1 billion by 2020, according to a report by Medtech Insight.
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