Titan® One Touch Release Inflatable Penile Prosthesis

Titan® One Touch Release Inflatable Penile Prosthesis

The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.

Inclusion Criteria:

• Participant has an estimated life expectancy of more than 5 years
• Participant has been diagnosed with erectile dysfunction (impotence)
• participant is willing to have the Titan OTR IPP implanted
• Participant is able and willing to complete all follow-up visits and procedures indicated in the protocol

Exclusion Criteria:

• Participant is unable or unwilling to sign the Informed Consent Form and /or comply with all follow-up requirements according to the study protocol
• Participant had a previous penile prosthesis or prior penile enlargement surgeries
• Participant has a compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
• Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
• Participant currently has uncontrolled or severe diabetes or other disease significantly reducing wound healing ability
• Participant does not have the manual dexterity or mental ability to operate the pump
• Participant has chordee or priapism
• Participant has penile sensory neuropathy
• Participant has serious bleeding disorder