Although the device has only been commercially available for about two years, Dr. Kern is confident that long-term follow-up studies will continue to demonstrate the efficacy of these implants. “We think that early outcomes correlate with late outcomes,” he said. “It is highly suggestive that the short-term data that we have will correlate with the long-term data.”
Explore This IssueMarch 2014
—David Kennedy, MD
What the Science Shows
Unlike most medical devices that only receive FDA clearance for use based on evidence of safety, the steroid-eluting implant was approved by the FDA through the more rigorous pre-market approval review process that requires evidence of both safety and efficacy. “This is the first product in my memory for the post-surgical management of chronic rhinosinusitis that has been FDA approved,” said Timothy Smith, MD, MPH, FACS, director of the Oregon Sinus Center, chief of rhinology and sinus surgery, and professor in the department of otolaryngology–head and neck surgery at Oregon Health and Science University in Portland. He is also a consultant with Intersect ENT and an ENTtoday editorial board member.
Current evidence shows that the use of the steroid-eluting implants maintains the results of sinus surgery by diminishing the extent of post-operative inflammation, mucosal adhesions, polyposis, and post-operative middle turbinate lateralization, and consequently reduces the need for oral steroids (see “The Research on Steroid-Eluting Implants, below).
Given the sound science behind steroid-eluting implants, the American Rhinologic Society has issued a formal position statement endorsing the use of biomaterials such as drug-eluting implants to improve outcomes and reduce complications of sinonasal surgical procedures.
What Clinicians Say
What these implants help to achieve, said Dr. Kennedy, who has been using the implants both at the end of surgery and in the outpatient clinic, is the critically important goal of getting the sinus cavity back to normal. “All patients with sinusitis who undergo sinus surgery have persistent disease that is usually asymptomatic. So symptoms get better after surgery, but the disease remains,” he said. “If you can resolve the persistent cavity disease and get the cavity back to truly normal, we have previously demonstrated that those patients do well and none of them need a surgical procedure over a nearly eight-year follow-up period.”
Patients he thinks are the best candidates for the implants are those with nasal polyps, particularly patients with polypoid rhinosinusitis, patients with significant hypertrophic mucosa, patients who don’t tolerate oral steroids, and those with recurrent disease who have had prior surgery.