Zenflow, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the Zenflow Spring Implant and Delivery System for the treatment of symptoms associated with benign prostatic hyperplasia (BPH), also known as enlarged prostate. The Zenflow Spring Implant and Delivery System is a novel, first-line interventional therapy (FIT) that provides urologists and their patients with a minimally invasive option that has proven long-term durability and unique safety advantages, including no post-procedure catheterisation and the ability to reverse treatment if desired.

Designed with the patient experience in mind, the Zenflow Spring Implant and Delivery System opens the urethra while preserving natural anatomy through a proprietary small spring-like implant. The Spring is the only FDA-approved FIT in a range of lengths and diameters, allowing for patient personalisation. It is made from a superelastic shape-memory material and delivered in an outpatient setting using the recently FDA-cleared Zenflow Spring Scope – a single-use, flexible cystoscope. This approval represents the very first FDA-approved BPH therapy delivered via a flexible cystoscope, which enhances patient comfort and recovery. Unlike other BPH interventions, the Zenflow Spring Implant and Delivery System eliminates burning, cutting, piercing, or resecting tissue. Zenflow’s unique design also offers complete reversibility without fear of complications commonly associated with other minimally invasive BPH treatments.

“Today’s FDA approval marks the culmination of years of innovation,” said Shreya Mehta, CEO of Zenflow. “Urologists and patients alike have long sought a flexible, gentle solution that combines the reversibility of medication with the long-term durability of an interventional approach. For the first time, men living with BPH symptoms have a choice that offers relief without compromise. We are excited to bring this new therapy to market.”

“First-line interventional therapy with the Zenflow Spring Implant and Delivery System provides effective symptom relief with rapid recovery, minimal side effects, and preserved treatment adaptability,” said Dean Elterman, M.D., Associate Professor at the University of Toronto and an attending urologist at the University Health Network. “The FDA’s approval of this novel treatment offers hope to men living with BPH because it simultaneously improves disruptive BPH symptoms while preserving sexual function.”