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Contura wins FDA premarket approval for hydrogel injection

Contura announced that it won FDA premarket approval for its Bulkamid hydrogel injection for treating stress urinary incontinence (SUI).

Bulkamid is Contura’s proprietary device designed for treating SUI due to intrinsic sphincter deficiency in adult women with SUI or stress predominant mixed incontinence. According to a news release, the product is currently marketed in more than 25 countries, while an ongoing North American pivotal study on the efficacy and safety of Bulkamid formed the basis of Contura’s approval.

 

 

Source: https://www.massdevice.com/contura-wins-fda-premarket-approval-for-hydrogel-injection/

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