Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED

Exclusion Criteria

• •Castrate and late onset hypogonadism
• •History of Priapism or Peyronie's Disease
• •Surgery or radiotherapy of the pelvic region
• •Anatomic penile deformations or penile prosthesis
• •Treatment with antiandrogens
• •Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.)
• •History of urothelial or colorectal cancer
• •Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy
• •Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days
• •Subjects who are taking anticoagulation or anti-platelet therapy
• •History of psychiatric disorders, premature ejaculation and drug or alcohol abuse
• •Subjects who are incarcerated
• •Subjects who are cognitively challenged
• •Serious heart or lung disease
• •Pregnant partner