|Intersect's Propel sinus implant, the size of a quarter--Courtesy of Intersect ENT|
Now-public Intersect ENT touted three studies in the International Forum of Allergy & Rhinology, saying the results of its clinical studies demonstrated the benefits of its Propel and investigational Resolve implants for use in patients following sinus surgery.
The company said its latest 5-patient clinical trial of the steroid-eluting Resolve demonstrated the product's safety, with a procedural success rate of 100%. Like Propel, Resolve dissolves after releasing the steroid mometasone furoate into the sinus lining to reduce inflammation. It is for chronic sinusitis patients with polyps, which recur in 60% of patients following endoscopic sinus surgery and are the leading cause of revision surgery, according to the company.
The safety data come on the heels of the Resolve clinical trial announcement at the American Rhinologic Society meeting in Orlando, FL. At three months, 53% of Resolve patients no longer needed repeat endoscopic sinus surgery, compared with 23% of patients in the control group, according to the study abstract.
|Intersect CEO Lisa Earnhardt|
"We are pleased with the positive results from these studies, which continue to build upon the solid foundation of clinical evidence supporting the benefits of our technology for patients with chronic sinusitis," said CEO Lisa Earnhardt in a statement.
Finally, the last study consisted of 20 patients who were given the FDA-approved steroid-eluting Propel within 7 days of surgery. According to Intersect, 90% of patients reported being very satisfied.
"In previous studies, placement of Propel immediately following sinus surgery resulted in reduction of postoperative interventions, inflammation, scarring, and reduced need for oral steroids during the recovery period. This case series shows that use of Propel in the days following sinus surgery leads to similar improvements in surgical outcomes in patients who, for whatever reason, are not treated with Propel during the initial surgery," said Dr. Keith Matheny of Collin County Ear, Nose, and Throat in Frisco, TX, in a statement.
Both products are designed to be implanted in the physicians' office during a routine postoperative visit.
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