Intersect ENT has announced the publication of a pooled analysis of steroid releasing implants in patients following frontal sinus surgery.
The company announced the publication of a pooled analysis in the International Forum of Allergy & Rhinology, the official journal of the American Rhinologic Society, of the company’s PROPEL Contour and PROPEL mini steroid releasing sinus implants showing improved outcomes of frontal sinus surgery.
The analysis included a total of 160 patients enrolled in two clinical trial cohorts. Patients were randomized following sinus surgery to receive an implant in one frontal sinus ostium with the contralateral ostium as control.
The pooled analysis showed that the PROPEL frontal steroid releasing implants significantly improve endoscopic outcomes of frontal sinus surgery compared to surgery alone.
The use of implants resulted in a relative reduction in the need for postoperative interventions of 46.8% at Day 30. A significant reduction in postoperative interventions was also observed at Day 90. There were no implant-related adverse events.
The study lead author Dr Ameet Singh said: “Frontal sinus surgery in patients with chronic rhinosinusitis has historically been associated with poorer outcomes than that of the other paranasal sinuses.
“This analysis provides important insights into outcomes in various patient subgroups and also demonstrates that PROPEL implants improve the outcomes of frontal sinus surgery by reducing the need for post-operative interventions through 90 days.”
Placed following endoscopic sinus surgery, the PROPEL family of implants is designed to maintain the surgical opening and prop open the sinus ostia while delivering drug directly to the sinus lining as the implant dissolves.
Intersect ENT president and CEO Lisa Earnhard said: “We are very pleased to see the positive findings of this study added to the robust pool of clinical evidence supporting our steroid releasing implants.
“We’re delighted that the PROPEL family of implants continues to be a strong, evidence-based option for ENTs seeking improved outcomes for patients following sinus surgery.”
Intersect ENT’s PROPEL products are the first and only dissolvable steroid releasing sinus implants approved by the FDA.
Clinically proven to improve outcomes for chronic sinusitis patients following sinus surgery, PROPEL sinus implants mechanically prop open the sinuses and release mometasone furoate, an advanced corticosteroid with anti-inflammatory properties, directly into the sinus lining then dissolve.
PROPEL’s safety and effectiveness for use in ethmoid sinuses is supported by Level 1-A clinical evidence from multiple clinical trials, which demonstrates that PROPEL implants reduce inflammation and scarring after ethmoid sinus surgery, thereby lessening the need for post-operative oral steroids and repeat surgical interventions.
PROPEL is indicated for the ethmoid sinus; PROPEL Mini is indicated for the ethmoid and frontal sinuses; and PROPEL Contour is indicated for the frontal and maxillary sinuses.
Intersect ENT is dedicated to transforming ear, nose and throat care by providing innovative, clinically meaningful therapies to physicians and patients.
Source: Company Press Release