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Intersect ENT announces clinical results from three studies evaluating steroid releasing implants placed in physician’s office

Intersect ENT, a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, announced positive results from three clinical studies evaluating treatment of patients with sinus disease in the physician’s office.

Findings from the studies, which assessed the company’s flagship PROPEL sinus implant and two investigational products, were presented during the annual meeting of the American Rhinologic Society, held in conjunction with the AAO-HNSF meeting in Dallas.

"More than 500,000 patients undergo sinus surgery in the operating room every year, but there are many more suffering from chronic sinusitis who either don’t want to undergo a procedure under general anesthesia, or have symptoms that are not severe enough to warrant surgery," said Lisa Earnhardt, president and CEO, Intersect ENT.

The studies evaluated steroid releasing sinus implants placed in the office to maintain patency and reduce inflammation for patients suffering from chronic sinusitis.

Joseph Han, M.D. (Norfolk, Va.) presented long-term results from a study evaluating office-based treatment with an investigational steroid releasing implant currently called RESOLVE.

The RESOLVE implant is designed as a less invasive alternative to treat patients with recurrent sinus obstruction that would otherwise warrant revision surgery. Data demonstrated durability at six months, with treated patients experiencing statistically significant improvement in symptom scores, ethmoid sinus obstruction and polyp grade, compared to controls.

In addition, control patients were at 3.6 times higher risk of remaining indicated for revision sinus surgery than treated patients.
Keith Matheny, M.D. (Frisco, Texas) presented results of a 20-patient study assessing patient-reported and endoscopic outcomes after placement of the PROPEL steroid releasing implant following sinus surgery during a post-operative office visit.

Findings included a statistically significant improvement in patient symptoms observed at four weeks, which were sustained to 12 weeks. Statistically significant reductions were also observed in ethmoid sinus inflammation. The results suggest a therapeutic effect sustained beyond the implant’s biodegradation.

William Brown, M.D. (Miami, Fla.) presented three-month results from the EXCEED study evaluating the company’s newest investigational bioabsorbable steroid eluting implant, currently called NOVA.

EXCEED evaluated the feasibility, safety and efficacy of NOVA when placed in frontal and maxillary sinus ostia following dilation in the physician’s office. Implants were successfully placed in 96% of sinuses. At three months, the study showed reduction in patient symptoms, inflammation and scarring. No patients required oral steroids or surgical intervention during follow-up.

Intersect ENT’s PROPEL and PROPEL mini are the first and only steroid releasing sinus implants approved by the FDA for use in patients following ethmoid sinus surgery. The products release mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining, then dissolve.

Use of PROPEL maintains the open passages created in surgery, reducing the need for oral steroids and additional surgical procedures. PROPEL’s effectiveness is supported by the highest level of clinical evidence, Level 1a, showing reduction of postoperative intervention, inflammation, scarring, and need for oral steroids in post-operative patients.