TY - JOUR
T1 - A novel anchoring system for pelvic organ prolapse repair
T2 - an observational study
AU - van Raalte, Heather
AU - Bhatia, Nina
AU - Mangel, Jeffrey
AU - Ryckebusch, Hugo
AU - Roovers, Jan-Paul
N1 - Funding Information: We would like to thank Prof Mark Cook, anatomist at the University of Minnesota Medical School, USA, for his assistance with the human cadaver studies. Funding Information: This study was sponsored by Coloplast Corp., Minneapolis, MN, USA; the sponsor assembled a team of collaborators to design this study. Authors independently completed the writing of the report and submitted the article for publication. Publisher Copyright: © 2023, The Author(s).
PY - 2023/7
Y1 - 2023/7
N2 - Introduction and hypothesis: Sacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System. Methods: An observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter). Results: Nineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N. Conclusion: The innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.
AB - Introduction and hypothesis: Sacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System. Methods: An observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter). Results: Nineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N. Conclusion: The innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.
KW - Anchoring device
KW - Native tissue surgery
KW - Pelvic organ prolapse
KW - Sacrospinous ligament fixation
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85146290313&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00192-022-05444-7
DO - https://doi.org/10.1007/s00192-022-05444-7
M3 - Article
C2 - 36645441
SN - 0937-3462
VL - 34
SP - 1593
EP - 1598
JO - International urogynecology journal and pelvic floor dysfunction
JF - International urogynecology journal and pelvic floor dysfunction
IS - 7
ER -