Sano V First In Human Study to Treat ED

A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System

A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System

Inclusion Criteria:

1. Patient understands and has signed the study informed consent form.
2. Documented history of erectile dysfunction
3. Sexually active

Exclusion Criteria:

- 1. Current participation in any clinical study with any investigational drug or device.

2. Patient is known or suspected not to tolerate the procedure, including exposure to contrast 3. Active infection or fever that may be due to infection 4. Life expectancy < 2 years due to other illnesses