Zenflow Wins FDA Nod for Spring Implant, Delivery System for BPH

Zenflow has gained U.S. Food and Drug Administration (FDA) approval for its Zenflow Spring implant and delivery system to treat symptoms associated with benign prostatic hyperplasia (BPH), also known as enlarged prostate.

The novel, first-line interventional therapy offers urologists and patients a minimally invasive option with long-term durability and safety advantages, the company said. That includes no post-procedure catheterization and the ability to reverse treatment if desired.

Zenflow’s implant and delivery system opens the urethra and preserves natural anatomy with a small, spring-like implant. It’s 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.

Unlike other BPH interventions, the company said the implant and delivery system removes burning, cutting, piercing, or resecting tissue. Its design also provides complete reversibility without the fear of complications related to 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.”

Data supporting Zenflow Spring’s FDA approval

The company’s BREEZE pivotal study showed responder rate was 60% compared to 33% for sham at one year. There was a mean International Prostate Symptom Score (IPSS) improvement of 37% exceeding the pre-specified clinical success threshold of 30%.

99% of men didn’t need a post-procedure catheter and there were no serious adverse events reported, with an overall related adverse event rate of 13%. 71% of subjects said the implant and delivery system improved urinary symptoms. There was also no deterioration in sexual function reported.

In pilot studies, the responder rate (proportion of subjects with ≥30% improvement in IPSS) was 74% at three years, similar to 75% at one year and 70% at two years, with no deterioration in erectile or ejaculatory function over three years.

“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, MD, 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.”