Information Provided By:
Fly News Breaks for October 28, 2019
ELGX
Oct 28, 2019 | 12:46 EDT
The FDA this morning issued a safety notice cautioning clinicians on the risk for endoleaks with Endologix's AFX with Duraply/AFX2 products after reviewing recent real world evidence, Piper Jaffray analyst Matt O'Brien tells investors in a research note. The FDA had previously issued a Class I recall for the company's first generation AFX system, and is now recommending lifelong yearly follow-up for patients implanted with second generation devices as well, the analyst points out. He estimates that AFX represented a little over half of Endologix's sales in Q2 and believes today's communication "might be a modest headwind to sales in the coming quarters." O'Brien sees this as another negative data point on AFX and remains cautious on the abdominal aortic aneurysms market as well as Endologix shares. He keeps a Neutral rating on the name.
News For ELGX From the Last 2 Days
There are no results for your query ELGX