Zenflow Receives the US FDA Approval for Zenflow Spring Implant and Delivery System for Benign Prostatic Hyperplasia (BPH)

Shots:

• The US FDA has approved Zenflow Spring Implant & Delivery System, a first-line interventional therapy, for the treatment of BPH-associated symptoms
• Assessed in the BREEZE study, the system met all 1 & 2EPs, showing a 60% responder rate vs 33% for sham & a 37% IPSS improvement exceeding the 30% success threshold at 1yr., with 71% reporting symptom relief, 66% willing to recommend the therapy, & no decline in sexual function
• The system was also assessed in the ZEST trials, which showed significant, durable IPSS reductions, with pilot-study responder rates (pts with ≥30% improvement in IPSS) of 75% at 1yr., 70% at 2yrs., & 74% at 3yrs., & no decline in erectile or ejaculatory function over 3yrs.

Ref: Globe Newswire | Image: Zenflow |Press Release

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