Prefyx PPS™ System

Product Information

Safety - Placement of the sling that is outside the pelvic bowl potentially reduces the incidence of organ and vascular injury.¹.

Efficacy - In an ongoing prospective clinical trial, the Prefyx PPS System demonstrated positive success rates.*
* Results from an interim analysis and may not represent the trial study outcomes.
* Patients receiving an off-protocol intervention were excluded from the analysis.

Time - Constant visual confirmation of the needle tip location during sling placement, without the blind window associated with other sling placement techniques. Promotes potentially faster placement.

Device Illustration

Device Highlights

1. Needle
2. Pusher
3. Handle
4. Dilator Tube
5. Mesh
6. Centering Tab

Additional Information

* Results from an interim analysis and may not represent the trial study outcomes. * Patients receiving an off-protocol intervention were excluded from the analysis.
1 A. Preliminary Procedural and Safety Data from the United States Clinical Study on the AMS Monarc® Subfascial Hammock,as presented at the International Continent Society meeting August 25, 2004 Moore R1, Miklos J1, Knoll L D2, Dupont M3, Winkler H A4, Lind L4, Kohli N5, Serels S6, Karram M7, Walters M8, Davila W9. 1. Northside Hospital, 2. Center for Urological Treatment, 3. Dupont Center for Urology/Urogynecology, 4. North Shore University Hospital, 5. Brigham & Women's Hospital, 6. Urology Associates of Norwalk, 7. Good Samaritan Hospital, 8.Cleveland Clinic, 9. Cleveland Clinic Florida B. Kuuva, N. and Nilsson, C.G. A Nationwide analysis of complications associated with tension free vaginal tape (TVT) procedure. ACTA OBSTET GYNECOL STAND 2002; 81: 72-77 C. Meschia M. et al. Tension free vaginal tape: analysis of outcomes and complications in 404 stress incontinent women (Int. Urogynecol. J. [2001] Supplement to Suppl 2: S24-S27) D. MAUDE - http://www.fda.gov/cdrh/maude.html E. Data on File Boston Scientific Corporation * Results from an interim analysis and may not represent the trial study outcomes

The Prefyx PPS™ System is a sterile, single use system consisting of one (1) delivery device and one (1) mesh assembly. Store at a controlled room temperature. Do not expose to organic solvents, ionizing radiation or ultraviolet light. Rotate inventory so that devices are used prior to the expiration date on package label.

Warranty:
Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument, as well as other factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond BSC’s control, directly affect the instrument and the results obtained from its use. BSC’s obligation under this warranty is limited to the repair or replacement of this instrument and BSC shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this instrument. BSC neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. BSC assumes no liability with respect to instruments reused, reprocessed or resterilized and makes no warranties, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.