Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
• Patients who are receiving chemotherapy at the time of enrolment.
• Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.
• Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.
• Uncontrolled diabetes (HbA1c ≥ 9.0% [≈75 mmol/mol], measured within 90 days prior to surgery.
• Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
• Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
• Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal [serum creatinine > 2.0 mg/dl], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or in the judgment of the physician investigator preclude safe procedure.
• Lacking manual dexterity or mental abilities necessary to operate the device.
• Expected life expectancy \< two years.
• Unwilling or unable to sign the Informed Consent.
• Unwilling or unable to comply with the follow-up study requirements.
• Psychogenic erectile dysfunction
• Currently participating in an investigational drug or another investigational device exemption (IDE) study.
• The cognitively challenged subjects and subjects with any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study questionnaires.
• Incarcerated subjects
• Subjects who are currently using, or who have not previously attempted and failed, standard non-surgical ED therapies including oral or topical treatments.