Propel mometasone furoate implant
Propel mometasone furoate implant (trade name Propel), is a bioabsorbable steroid-eluting stent developed by Intersect ENT. It is implanted after surgery to assist in treating chronic rhinosinusitis. It delivers steroids over a 30-day period prior to dissolving, and has been shown to improve outcomes of surgery.
Propel uses sustained release technology to deliver mometasone furoate directly to the sinus mucosa. The device is inserted into an open surgical cavity. The device has what is described as a "spring-like design," which conforms to a patient's sinus anatomy and props open the sinus cavity. Anti-inflammatory medicine is then delivered over a 30-day period with the device dissolving so it does not need to be removed. The use of Propel reduced the need for additional surgical procedures and steroid pills, which can have detrimental side effects. Propel is also manufactured in a smaller version known as the Propel mini.
A randomized, double-blind pilot study of Propel using 43 patients during an eight-week trial period showed no adverse effects. The intra-patient control design compared a drug-eluting implant (Propel) to a non-steroid eluting implant. It also showed adhesion rates of 5.3% for those using Propel in comparison to 21.1% for those who received a non-steroid eluting implant. The trial showed less than 10% of stent material present after 30 days with the remaining completely absorbed by the end of the eight-week trial.
In 2011, The Laryngoscope published the ADVANCE study on the safety and effectiveness of steroid-eluting implants using the Propel device as supplied by Intersect ENT. The conclusion of the study reported favorable rates of sinus patency, with minimal inflammation and adhesions after 30 days. Patients reported symptom reductions were also collected to 6 months using the Sino-Nasal Outcome Test-22 Questionnaire and Rhinosinusitis Disability Index. The study showed a positive impact of using the device and demonstrated improved patient symptom scores with no evidence of ocular risk.
The ADVANCE II study, a randomized double-blind study, published by the American Academy of Otolaryngology – Head and Neck Surgery in 2012 was evaluated by an independent, blinded panel of surgeons and resulted in a 29% reduction in postoperative interventions and a 52% decrease in lysis of adhesions in all 210 patients involved in the study.
A Meta Analysis, published by the International Forum of Allergy and Rhinology in 2012, pooled the efficacy data from the pilot and ADVANCE II studies. This resulted in the first Level 1-A evidence in support of a sinus surgery product. The analysis showed Propel reduces the need for oral steroids by 40%, decreases adhesions by 70%, and decreases the need for post-surgical medical and surgical therapies by 35%.
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