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A Novel BPH Device Designed Around Your Workflow.
A Novel BPH Device. Designed Around Your Workflow.
FloStent is an investigational nitinol stent delivered via standard flexible cystoscopy — no capital, no proprietary system, no new equipment. FloStent is designed to integrate into a standard cystoscopy workflow — with no capital investment, no new equipment, and no proprietary delivery system.
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 III | USA/AUS • RCT, N=215 • Enrollment complete | Primary efficacy: ≥25% IPSS superiority vs. sham at 3 months (results pending) |
Rapid II | AUS/MX/NZ • Open-label, N=55 | IPSS –8.3 at 2 wks; –11.3 at 1 yr; –11.6 at 2 yrs • QOL –3.0 at 1 yr |
Rapid I | Panama • Open-label, N=26 | 100% deployment success; safe retrieval in all patients at 1 year |
Data from RAPID I and II are from earlier-stage open-label studies. Results are not a guarantee of outcomes in the pivotal study. RAPID-III enrollment is complete; pivotal results are pending FDA submission.
15 Million Patients. 97% Without a Device Option.
The current BPH treatment landscape leaves the vast majority of patients on medication or watchful waiting. FloStent is being developed to offer a new pathway — one that fits the office setting and activates patients who want more than chronic medical management.
97%
BPH patients non-surgically managed
~400K
Surgical procedures/year (only 3%)
~15M
Potential first-line device candidates
Don't just take our word
Stay Ahead of FloStent’s Approval.
FloStent is not yet commercially available. With RAPID-III enrollment complete and results pending, Rivermark Medical is actively preparing for FDA submission. Physicians interested in learning more about FloStent or being among the first to offer it upon approval are encouraged to reach out.
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