Advice
The technology
The technology
PROPEL (Intersect ENT) sinus implants are designed to keep the sinus open and deliver steroids directly to the sinus mucosa after sinus surgery. It's made of a synthetic bioabsorbable co-polymer with a matrix-like structure. It's also impregnated with 370 micrograms of mometasone furoate, an anti-inflammatory drug, which it releases gradually into the sinus mucosa over a 30-day period.
There are 3 versions of PROPEL: PROPEL for the ethmoid sinus, PROPEL Mini for the ethmoid sinus and frontal sinus opening, and PROPEL Contour for the frontal and maxillary sinus ostia. All of them have a syringe-style delivery mechanism, a sheath and distal tip. The sheath and distal tip vary in length depending on the different anatomies of sinus sites where they are used. Additional tools may be provided depending on the variant. The sinus implant is delivered to the sinus site through the nostrils and opens out once it's in place. The implant itself is designed to dissolve within 30 to 45 days.
Innovations
The innovative aspects of the technology are that it is both a spacer and an inflammatory drug delivery device. The company claims this helps reduce the need for postoperative intervention, including surgery and oral corticosteroids, by reducing inflammation, polyposis and middle turbinate lateralisation.
Current care pathway
Current guidance concentrates on surgery and treatments before surgery. There are no guidelines on post-surgical interventions.
Maintenance therapies maintain the sinus opening created by surgery. They include nasal irrigation with a saline solution and intranasal corticosteroids (for example, mometasone or fluticasone) for up to 3 months.
Follow up should be tailored to individual patient needs and may be influenced by other factors such as allergies and comorbidities. There is no significant evidence to support frequent postoperative debridement of sinus cavities.
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
The technology would be used by surgeons for people with chronic rhinosinusitis, immediately after endoscopic sinus surgery.
Chronic sinusitis is a common condition estimated to affect around 10% of adults. Prevalence increases with age, and it's more common in women, and people with asthma, chronic obstructive pulmonary disease, or a history of allergies. The company estimates that in England 30,000 people (60,000 implants) could benefit from the procedure each year.
Resource consequences
Three studies reporting economic outcomes related to PROPEL were identified in searches and by the company. Javanbakht et al. (2020) is a cost‑effectiveness analysis undertaken using a UK NHS perspective, but with the clinical parameters taken from a study that was conducted in the US (Han et al. 2012). Rizzo et al. (2016) and Rudmik and Smith (2014) use a US healthcare perspective and report outcomes related to budget impact and cost effectiveness. These studies provide some evidence that over time PROPEL may be associated with similar costs compared to current practice.