Description: This site provides information for participants and physicians about an FDA-supervised study of the Infla10® Pulse™ device series.
A U.S. Food and Drug Administration-regulated research study evaluating an investigational inflatable penile prosthesis for men with erectile dysfunction. Screening is required and not everyone qualifies. Participation is voluntary.
For eligible beneficiaries, some routine care services may be covered under Medicare rules (Category B IDE). Coverage varies.
Eligibility is determined by the study team based on specific medical criteria. You may be considered if you: