FDA Grants Expanded Approval to SRS Medical Systems’ Temporary Prostatic Stent

December 6, 2022

The FDA has given the okay to SRS Medical Systems’ premarket approval application (PMA) supplement, expanding indications of the company’s Spanner temporary prostatic stent to allow temporary use up to 30 days for patients with enlarged prostates who are not candidates for drug treatments and surgery.

The device gained PMA approval in 2006 for use up to 30 days to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia — prostate gland enlargement — and after initial post-treatment catheterization.

The stent can be inserted in an office setting and eliminates the need for patients to carry a urine bag, as the stent is an alternative to the Foley urinary catheter.

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