This study is about testing a new device, **Rigicon Infla10®**, to help men with erectile dysfunction (ED). **Erectile Dysfunction** means having trouble getting or keeping an erection for sex. Many men, especially as they get older or have health issues, face this problem. This study looks at how safe and helpful the Rigicon Infla10® device is for up to three years after it is implanted. This device is inflatable, which means it can be pumped up when needed for sex.
- The study lasts up to 3 years with follow-up visits.
- Participants must be men aged 22 or older with ED.
- Certain health conditions may prevent you from joining.
If you join, you must agree to have the device implanted and attend follow-up visits. The study checks if the device works well and is safe. Remember, there are certain health conditions that may prevent you from being part of this study. If you want to participate, make sure you understand all the requirements and talk to your doctor for more information.