Performance Evaluation of the AMS CONTINUUM™ Device

Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy

To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.

Surgery is the main treatment for localized prostate cancer. The most common technique is a "radical prostatectomy," which involves removing the prostate gland, seminal vesicles and nearby lymph nodes. Radical prostatectomy is a major operation, most suitable for otherwise healthy men whose cancer does not appear to have spread.One of the most technically challenging aspects of this surgery is reconstruction of the interrupted urinary tract by hand suturing the bladder neck anastomosis, in which the bladder neck is sewn to the urethra after the prostate has been removed. CONTINUUM™ (study Device) is a surgical device intended to be used as part of the radical prostatectomy procedure. The Device facilitates approximation of the bladder neck and urethral stump by bringing together and holding the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs. CONTINUUM™ also approximates the bladder and urethral stump to minimize extravasation, while simultaneously providing a conduit for drainage of urine from the bladder while the anastomotic site heals. The concept of the CONTINUUM™ device and the feasibility of its operation have been tested in animal and human studies. Pilot clinical studies in the United States (G060095) found that the majority of Subjects who received and were discharged with the Device demonstrated a water-tight vesico-urethral anastomosis at the first Device removal visit. Additionally, no unanticipated adverse device effects (UADEs) were reported. The intent of this study is to verify CONTINUUM™ device performance across a variety of US sites and physicians using updated CONTINUUM™ device design modifications and physician training methodology on Device implant and removal techniques prior to initiation of a randomized US Pivotal study.

Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.

Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement

Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.

To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.

To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.

Inclusion Criteria: All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study. The Subject is willing and able to return for study follow-up visits according to the protocol. The Subject can be off diuretics and blood thinners for at least one week prior to surgery. Exclusion Criteria: If contraindicated for surgery Inability to understand the study or a history of non-compliance with medical advice Unwilling or unable to sign an Informed Consent Form (ICF) Participation in another clinical trial Previously implanted urological device A history of Recurrent urinary tract infections (UTI) A history of stricture disease Prior invasive prostate treatments (e.g., TURP, TUIP, laser therapy, radiotherapy, cryotherapy) Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease) Uncontrolled insulin-dependent diabetes Chemotherapy within the past 6 months Non-topical steroid use within the past 6 months History of connective tissue or autoimmune conditions Compromised immune system Allergy to nitinol, nickel, titanium or silicone Body Mass Index greater than or equal to 30 American Society of Anesthesiologists Score of > 3 Prostate size greater than or equal to 50 grams as determined by TRUS