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FDA Approves Steroid-Releasing Implant for Chronic Sinusitis
Product will be offered in select hospitals this month (Nov. 6)
The FDA has approved the steroid-releasing product Propel mini (Intersect ENT Inc.) — a smaller version of the Propel (mometasone furoate) implant, which received agency approval last year.
Propel is a spring-like device that is inserted by a physician after endoscopic sinus surgery. The implant expands to prop open the sinus; gradually delivers a steroid with anti-inflammatory properties directly to the sinus lining; and then dissolves into the body.
Propel mini provides the same dose of mometasone furoate provided by Propel, allowing patients with less extensive surgery and a smaller sinus anatomy to benefit from improved surgical outcomes, according to the manufacturer.
The product will be offered in select hospitals starting this month and will be launched nationwide in 2013.
Chronic sinusitis is associated with difficulty breathing, facial pain, headache, and a reduced sense of smell or taste. The condition affects 31 million people in the U.S. Each year, 500,000 patients undergo sinus surgery to treat the disorder. Although surgery is effective, most of the patients experience recurrent symptoms within the first year; as many as 25% undergo revision surgery because of recurrent obstruction of the sinus cavity.
A meta-analysis of two randomized, controlled, multicenter clinical studies demonstrated that the use of the Propel implant reduced postoperative interventions by 35% compared with a control group (P = 0.0008) after endoscopic sinus surgery. Propel also decreased adhesion lysis by 51% (P = 0.0016); the need for oral steroids to treat inflammation by 40% (P = 0.0023); and frank polyposis by 46% (P < 0.0001).
Source: Intersect ENT Inc.; November 6, 2012.