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Trendlines portfolio company receives FDA clearance for sinus stent
ONE of the companies in Catalist-listed startup incubator The Trendlines Group's portfolio has received regulatory clearance from the United States Food and Drug Administration (FDA) for a stent which helps reduce complications from sinus surgery.
Up to 30 per cent of functional endoscopic sinus surgeries are unsuccessful due to scarring and recurrent inflammation that closes the nasal openings and requires revision surgery.
The company, called ST Stent, developed a removable stent to be placed after functional endoscopic sinus surgery, that keeps the sinus cavity open for up to 28 days - long enough for the tissue to heal.
The stent improves patient outcomes and reduces the probability of revision surgeries, said The Trendlines Group in a press release on Wednesday.
In addition to chronic sinusitis, the stent can be used for nose job failures, chronic allergic rhinitis, and as a direct stenting as an alternative to sinuplasty.
"Following excellent results in our clinical trials performed on 30 patients earlier in 2017, we are extremely pleased to have received regulatory clearance from the FDA. This is a significant milestone for ST Stent which will allow us to market our product in the US," said chief executive Joseph Flomenbilt.