Propel - P100044
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Propel
PMA Applicant: Intersect ENT
Address: 1049 Elwell Court, Palo Alto, CA 94303
Approval Date: August 11, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100044a.pdf
What is it? The Propel sinus implant is a temporary, self-absorbing implant designed to keep the spaces within and around the sinuses open following sinus surgery. The Propel sinus implant is manufactured from a synthetic material which is absorbed by the body over 4 to 6 weeks following implantation. The implant contains the active ingredient, mometasone furoate, a steroid which suppresses inflammation in the area around the implant.
How does it work? The Propel sinus implant is inserted by a physician following functional endoscopic sinus surgery (FESS). The implant is designed to be self-retaining against the lining (mucosa) of the surgically enlarged ethmoid sinus (the sinus between eyes and nose). It self-expands to the appropriate size of the space created during the surgical procedure. A delivery system provides access to the ethmoid sinus and aids in the insertion of the implant.
When is it used? The Propel sinus implant is intended for use in patients 18 years of age or older following ethmoid sinus surgery to keep the sinus open thereby reducing the need for post-operative intervention such as surgically separating scar tissue formations and/or use of oral steroids.
When should it not be used? The Propel sinus implant should not be used in patients with:
- a suspected or confirmed intolerance to mometasone furoate.
- a known hypersensitivity to lactide, glycolide or caprolactone copolymers.
What will it accomplish? The Propel sinus implant stabilizes the bony structures inside the nose and prevents obstruction resulting from scar tissue formations. The Propel sinus implant is coated with mometasone furoate , a steroid known for its anti-inflammatory properties. The combination of the mechanical action of the implant and steroid-coating reduces the need for post-operative intervention such as surgically separating scar tissue formations and/or use of oral steroids.
Additional information: Summary of Safety and Effectiveness and labeling are available online.
- NIH- MedlinePlus – Tutorial – Sinus Surgery
- American Academy of Otolaryngology – Head and Neck Surgery – Sinus Surgery