A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

Assuming success of the VFIX anatomical observational study (protocol 300-08-009), in this pilot study approximately 20 subjects (excluding the Device Run-In (DRI) subjects) will undergo the VFIX procedure to evaluate the safety and effectiveness of the VFIX device in maintaining apical support for at least 6 months, in women with symptomatic apical prolapse.

Inclusion criteria

• Age greater than or equal to 18 years
• Subjects of child bearing potential have a negative blood or urine pregnancy test prior to the procedure and subject has completed childbearing
• Subject with apical prolapse at stage II or more and requiring treatment (C should be at least -1 cm)
• On reduction of the apical prolapse, leading edge of prolapse should be at or above the hymen
• If applicable, subject has small/normal size uterus and there is no elongation of the cervix as determined by clinical assessment
• The vaginal apex can reach the Sacrospinous Ligament (SSL) on exam
• Subjects are allowed concurrent incontinence procedure as required
• Concurrent perineal repairs and excision of excess vaginal tissue repairs as required
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent

Exclusion criteria

• Additional surgical intervention for POP repairs concurrent to the VFIX procedure (including, but not limited to sacrocolpopexy, paravaginal repair, colporrhaphy, mesh repair, etc)
• Experimental drug or experimental medical device within 3 months prior to the planned procedure
• Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
• Previous hysterectomy within 6 months of scheduled surgery.
• Coagulation disorder or on therapeutic anticoagulant therapy (except aspirin) at the time of surgery
• Nursing or pregnant
• Presence of cancers of the vagina, cervix, or uterus
• In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol