FDA approves Bulkamid for SUI in womenMarch 25, 2020
Contura announced that USFDA has approved its premarket application (PMA) for Bulkamid, a proprietary medical device for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency in adult women.
The pivotal North American study reporting on the efficacy and safety of Bulkamid for the treatment of female stress incontinence formed the basis of Contura’s PMA.
The US approval comes on the back of recent evidence showing that when women with SUI are given a choice of treatments, their preferred option is urethral bulking.
The minimally invasive Bulkamid treatment is increasingly being used in Europe and now represents the number one SUI treatment in the UK after conservative measures.
Bulkamid is a soft hydrogel that consists of 2.5% polyacrylamide and 97.5% water. Once injected, it provides additional volume to the urethra and acts as a scaffold for cells to grow through, helping to provide long-lasting relief of SUI symptoms.