Malleable Treatment – the Tactra Erectile Restoration Study Purpose The primary objective of the It MATTERS study is to assess erectile function at 6 months, post implantation of the Tactra™ Malleable Penile Prosthesis, demonstrating an improvement in quality of life from baseline Criteria Adult males with moderate to severe erectile dysfunction (IIEF-EF domain (questions 1-5 and 15) score of 1-16) Willing and able to undergo surgical implantation of the Tactra device Willing and able to complete the informed consent process Willing and able to comply with the follow-up requirements Negative urine culture Cannot: Subjects with a prior history of penile prosthesis surgery Subjects with a prior history of corporal dilation Subjects with a prior history of Peyronie’s disease Subjects with a prior history of priapism Subjects with a prostate condition that is expected to require surgical intervention during the course of the study Subjects receiving any other surgical erectile dysfunction treatment(s) while participating in the study (else subject voluntarily exits study) Subjects receiving other medical treatment for erectile dysfunction while participating in the study (else subject voluntarily exits study) Subjects receiving any other surgical treatment at the time of the Tactra implantation. Subjects whose total intracorporal length is not within the range of 14 cm to 27 cm. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor Subjects with need for intermittent catheterization Details It MATTERS will be a single-arm, non-randomized, prospective, multi-center study with follow-up occurring at 1 month, 3 months, 6 months, 12 months, and annually thereafter for up to 5 years. Subjects will serve as their own control as follow-up assessments will be compared to values obtained at baseline. Interested in more information on clinical research? Contact WK Physician Network Clinical Research at 318-212-8613 Interested in more information? Contact Us: Gerard Henry, M.D., Principal Investigator IRB: WIRB IRB Number: Trial Type: NA Sponsor: Boston Scientific