08.18.15
Menlo Park, Calif.-based Intersect ENT Inc., which makes technology for the treatment of ear, nose and throat conditions, has released preliminary results of Progress, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the Propel mini steroid releasing sinus implant when used following frontal sinus surgery.
The study met its primary efficacy endpoint, demonstrating a statistically significant 38 percent relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or need for oral steroid prescription, compared to surgery alone, the company reported. The device placement success rate was 100 percent and there were no device-related adverse events.
“Frontal sinus disease contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches, and is known to be the most difficult sinus to manage,” said Tim Smith, M.D., M.P.H., F.A.C.S, of Oregon Health and Science University, principal investigator of the study. “These results offer an exciting prospect for this group of patients.”
As many as one in four patients undergoing surgery for chronic sinusitis suffers from frontal sinus disease. The trial is intended to support an expanded indication for placement of Propel mini in the frontal sinuses, which are located behind the eyebrows. Propel mini is currently indicated for placement in the ethmoid sinuses, located just behind the bridge of the nose.
“We are pleased with the positive outcomes from Progress, which bring us another step closer to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis,” said Lisa Earnhardt, president and CEO of Intersect ENT. “Our next step will be to compile and submit the results to the [U.S. Food and Drug Administration] this year.”
The study met its primary efficacy endpoint, demonstrating a statistically significant 38 percent relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or need for oral steroid prescription, compared to surgery alone, the company reported. The device placement success rate was 100 percent and there were no device-related adverse events.
“Frontal sinus disease contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches, and is known to be the most difficult sinus to manage,” said Tim Smith, M.D., M.P.H., F.A.C.S, of Oregon Health and Science University, principal investigator of the study. “These results offer an exciting prospect for this group of patients.”
As many as one in four patients undergoing surgery for chronic sinusitis suffers from frontal sinus disease. The trial is intended to support an expanded indication for placement of Propel mini in the frontal sinuses, which are located behind the eyebrows. Propel mini is currently indicated for placement in the ethmoid sinuses, located just behind the bridge of the nose.
“We are pleased with the positive outcomes from Progress, which bring us another step closer to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis,” said Lisa Earnhardt, president and CEO of Intersect ENT. “Our next step will be to compile and submit the results to the [U.S. Food and Drug Administration] this year.”