Oceana Therapeutics' Solesta
This article was originally published in The Gray Sheet
Injectable treatment for fecal incontinence will be submitted for PMA approval in the first quarter of 2010, according to Oceana Therapeutics. The New Jersey firm acquired global marketing rights to Solesta from Swedish developer Q-Med in June. Solesta is a biocompatible substance composed of stabilized hyaluronic acid, including dextranomer. A 200-patient, randomized pivotal study of the minimally invasive device, with 12-month follow-up, "succeeded in meeting both primary endpoints," the firms announced Dec. 7
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Expanded indications for gastric banding?: FDA's Gastroenterology and Urology Devices advisory panel will meet Dec. 3 to discuss whether the agency should approve expanded indications for Allergan's Lap-Band adjustable gastric banding system. The firm is seeking approval for use in slightly less obese patients, with a body mass index of at least 35 or a BMI of at least 30 if the individual has one or more obesity-related health condition. Currently, the device is labeled for adults with BMIs of 40 or more, or greater than 35 if the patient has a comorbidity. On Dec. 2, the panel will discuss Oceana Therapeutics' PMA for its Solesta fecal incontinence treatment for patients who have failed conservative therapy. The firm's 200-patient pivotal study for the hyaluronic acid-based product met its primary endpoints (1"The Gray Sheet" Dec. 14, 2009)
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