A Novel BPH Device Designed Around Your Workflow.
FloStent is an investigational nitinol stent delivered through a standard flexible cystoscope, requiring no capital investment, proprietary system, or new equipment.
A New BPH Approach.
A Familiar Procedure.
FloStent® is an implant designed to expand the options you can offer patients seeking an alternative to chronic medical management. Placement through a standard flexible cystoscope supports an office-based approach, with controlled deployment and the flexibility to retrieve the implant as treatment needs evolve.
FITS YOUR PRACTICE
Integrates with your existing flexible cystoscope. No additional capital equipment required.
CONTROL DURING PLACEMENT
A dedicated delivery tool and multifunctional handle support deployment and positional adjustment.
FLEXIBILITY OVER TIME
Retrievable with standard urological instruments, allowing transition to other BPH therapies when appropriate.
A Rigorous Multi-Study Clinical Program
FloStent has been evaluated in three clinical programs. The RAPID-III pivotal trial has completed enrollment under FDA IDE approval. Results are being analyzed in preparation for FDA submission.
Study
Setting/Design
Key Early Findings
Rapid l
Panama
Open-label
N=26
100% deployment success; safe retrieval in all patients at 1 year
Rapid ll
AUS/MX/NZ
Open-label
N=26
IPSS -8.3 at 2 wks; -11.3 at 1 yr; -11.6 at 2 yrs
QOL -3.0 at 1 yr
Rapid lll
USA/AUS
RCT, N=215
Enrollment Complete
Primary efficacy: ≥25%
IPSS superiority vs. sham at 3 months (results pending)