Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc. Propel and propel mini bioabsorbable steroid-releasing sinus implants for treatment of chronic rhinosinusitis in adults. Lansdale: HAYES, Inc. Healthcare Technology Brief Publication. 2017 Authors' conclusions Sinusitis is an inflammation of the nasal cavity and paranasal sinuses that is estimated to affect 13% to 15% of adults in the United States, resulting in more than 30 million annual diagnoses.
Technology Description:
The Propel and Propel Mini sinus devices are self-expanding bioabsorbable stents formed of a synthetic polymer (L-lactide-co-glycolide) in a lattice pattern. Mometasone furoate (MF) is a topical synthetic corticosteroid with activity against nasal symptoms. Both Propel stents are coated with 370 micrograms (μg) of MF that is released locally to the mucosa over a 30-day period. The stents are placed via a proprietary endoscopic system in the sinus cavity following sinus surgery. The 23 millimeter (mm) by 5.2 mm Propel device is Food and Drug Administration (FDA) approved for use in the ethmoid sinus cavity; the smaller 16 mm by 4 mm Propel Mini stent is FDA approved for use in the ethmoid or frontal sinus cavity.
Clinical Alternatives:
Some form of sinus packing is generally provided following endoscopic sinus surgery (ESS). This may include saline dressings inserted manually, foam dressings that form a gel when hydrated, middle meatal spacers that prop open the sinus cavities but are incapable of drug delivery, and implantable drug-eluting stents. In addition, alternative sinus implants are marketed in the United States and elsewhere. Indexing Status Subject indexing assigned by CRD MeSH Absorbable Implants; Adult; Humans; Paranasal Sinuses; Sinusitis; Steroids Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo@hayesinc.com AccessionNumber 32018000014 Date abstract record published 30/01/2018 |