This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.
Male ≥22 years of age.
Diagnosed with erectile dysfunction (impotence).
Agree to receive Infla10® three-piece IPP as an ED treatment.
Willing to complete all protocol required for follow-up visits and tests.
Contraindication to general anesthesia.
Known allergy or sensitivity to product materials as indicated in the device labeling.
Previous penile prosthesis or prior enlargement surgeries
Diagnosed penile sensory neuropathy.
Rigicon, Inc.
Lead sponsor