
Participants must be 18-70 years of age and meet at least the following criteria:
Some people who meet the criteria listed above may not be eligible to participate in this clinical research study. This includes any person who has at least one of the following criteria, among others:
The criteria listed above are not the only eligibility requirements for this study. Only a clinical research study staff member can determine if you are eligible for this clinical research study.
What are the requirements for participants?
Following the surgery, participants will be asked, and are required,
to visit the clinical research study site at regular intervals
for a minimum of two years for evaluation by clinical research
study personnel.
Is there any cost for participants?
Participants enrolled in this study and receiving the investigational
device will not be responsible for any of the medical costs associated
with the study. The investigational device will be provided at no
charge. Neither the participant nor the participant's insurance
company will be billed for the surgery or any additional
tests or assessments associated with this clinical research
study.