FDA approved Zenflow's Spring Implant and Delivery System on December 11 under P250007. The South San Francisco company filed on March 11, so the review took 275 days. The label covers BPH in men with a prostatic urethral length of 25 to 45 mm and a prostate of 25 to 80 cc. Product code MER.
The Spring is a superelastic nitinol coil placed through a single-use flexible cystoscope. It holds the prostatic urethra open without cutting, heating or piercing tissue, comes in several lengths and diameters, and can be removed. In the BREEZE trial of more than 200 patients, 60% of treated men were responders at one year versus 33% on sham. Mean IPSS improved 37%, 99% of patients left without a catheter, and Zenflow reported no device-related serious adverse events.
ProVerum's ProVee, a competing nitinol expander, won its own PMA two days earlier under P250011. The two labels overlap: 30 to 80 cc for ProVee, 25 to 80 cc for Spring. Zenflow was founded in 2014 and raised a $31.4 million Series A in 2018. Cook Medical led its $24 million Series C in November 2024, with Invus Opportunities, F-Prime Capital and Medical Technology Venture Partners. Shreya Mehta is CEO.
Two original PMAs for the same indication in one week is rare. Both companies now face UroLift and Rezum in the urologist's office, with a sham-controlled label as the calling card.