ETHICON SECURESTRAP® Absorbable Strap Fixation Device
Superior acute fixation at various angles2,6
Appropriate tissue capture and penetration for secure acute fixation at multiple angles6
Our device has a unique, absorbable “strap” design uses 2 points of fixation to straddle mesh pores and fibers.7 The low-profile strap, minimal surface area leaves minimal foreign material exposed to viscera.3
Superior acute holding at various angles2,6
Each strap deploys with equivalent force, providing reliability.2
At 45 and 30 degrees, ETHICON SECURESTRAP™ Fixation Device has a statistically significant difference in median holding strength compared with AbsorbaTack† (P<0.05).6 At 90, 45, and 30 degrees, ETHICON SECURESTRAP™ Fixation Device has a statistically significant difference in median holding strength compared with SorbaFix** (P<0.05).6
Minimal to no pain
Proven to get patients back to their lives with minimal to no pain8
ETHICON SECURESTRAP® Absorbable Strap Fixation Device is shown in a preliminary study of patients from the International Hernia Mesh Registry (IHMR) to be safe and to provide an improvement in pain levels compared to baseline level.8¤
Shown to be safe with improved symptomatic pain levels and movement limitations in the same 12-month follow-up IHMR study.8¤
ETHICON SECURESTRAP® Absorbable Strap Fixation Device IFU
*As shown in benchtop in porcine flank tissue
§ As shown in a preclinical study
‡ Two points of fixation and mid-plane symmetry require that data be collected horizontally and vertically.
† AbsorbaTack™ Instructions for Use require that the distal tip of the device is at a right angle to the targeted tissue to facilitate appropriate insertion of the tack.
**SORBAFIX™ Instructions for Use state that the fasteners should be placed entirely into the tissue and the head of the fastener should be firm against the mesh or tissue in order to achieve the best fixation performance.
¤ Prospective, longitudinal study of ETHICON SECURESTRAP Fixation Device in hernia repair from the International Hernia Mesh Registry (IHMR). 88 patients (group 1) were treated with mechanical mesh fixation alone, and 98 patients with mechanical fixation + sutures (group 2). Hernia types (%) in group 1 and 2 were, respectively: incisional/ventral (43.2 and 74.5), umbilical (23.9 and 11.2), epigastric (11.4 and 4.1) and were mostly primary repairs (87.5 and 78.6) done laparoscopically (97.7 and 98.0). Most common adverse events, respectively: seroma (8.0% and 18.4%), hematoma (2.3% in group 1), procedural pain (2.3% and 2.0%), and urinary retention (2.0% in group 2). Hernia recurrences (up to 12 months) respectively: 1.1% (1 medically confirmed) and 7.1% (4 medically confirmed and 3 unconfirmed). Patients with symptomatic CCS pain and movement limitations scores, improved from baseline (70.9%; 61.1%) to 12 months (29.9%; 19.7%), respectively (p<0.001). A total of seventy-seven patients from groups 1 and 2 had 12-month data. The Carolinas Comfort Scale™ defines symptomatic pain as a score greater than 1 (mild but not bothersome symptoms) for at least 1 question within the domains of severity of pain, sensation of mesh, or movement limitation.
1. May 2013 – Fixation Share Update
2. Cardinale M. Angle fire competitive test. AST 2010-0199
3. Shnoda P. 28 day mesh fixation study of the ETHICON SECURESTRAP™ Fixation Device to evaluate mesh migration and tissue response using a swine model. PSE Accession: 09_0132, project: 67547
4. AbsorbaTack Instructions for Use. Covidien.
5. SorbaFix Instructions for Use. Bard Davol.
6. Cardinale M. Comparison of acute holding strength of an absorbable strap fixation device in porcine flank at various implantation angles (technical report).
7. Vailhe E. 510k Testing for Orion Mesh Fixation Strength. AST_2009_0312
8. Doerhoff C, Chudy M, Gauld J et al. Preliminary Outcomes using an absorbable fixation device for mesh fixation. AHS 2013 SECURESTRAP (poster).