ETHICON SECURESTRAP® Open Absorbable Strap Fixation Device
For open ventral hernia repair
The shape of innovation in open ventral hernia fixation
ETHICON SECURESTRAP® open absorbable strap fixation device a metric ruler on cannula designed to help ensure proper mesh overlap. A strap positioning tip is designed for proper strap placement with holding points to improve traction and tensioning with porous meshes.1,2
Proven to reduce patient pain post-hernia repair.3
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.3*
Shown to be safe with improved symptomatic pain levels and movement limitations in the same 12-month follow-up IHMR study.3*
Superior acute fixation at various angles4,5
Appropriate tissue capture and penetration at multiple angles5
At 45 degrees, ETHICON SECURESTRAP Fixation Device has a statistically significant difference in median holding strength compared with AbsorbaTack† (P<0.05).5
At 90 and 45 degrees, ETHICON SECURESTRAP Fixation Device has a statistically significant difference in median holding strength compared with SorbaFix‡ (P<0.05).5
Efficient and less stressful**
Deliver a significantly more efficient and less stressful repair§
89% reduction in fixation time versus suture fixation alone with ETHICON SECURESTRAP Open Absorbable Strap Fixation Device7
55% reduction in surgical stress versus suture fixation alone with ETHICON SECURESTRAP Open Absorbable Strap Fixation Device6,7
ETHICON SECURESTRAP® Open Absorbable Strap Fixation Device IFU
* 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.
† 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.
§ In IPOM procedures
** Shown in testing by surgeons in an animal model
1. ETHICON SECURESTRAP® Open Absorbable Strap Fixation Device. Instructions for Use. Ethicon, Inc.
2. 2016 Launch COBRA Presentation.
3. Doerhoff C, Chudy M, Gauld J et al. Preliminary Outcomes using an absorbable fixation device for mesh fixation. AHS 2013 SECURESTRAP (poster).
4. Cardinale M. Angle fire competitive test. AST 2010-0199.
5. Cardinale M. Comparison of acute holding strength of an absorbable strap fixation device in porcine flank at various implantation angles (technical report).
6. Roy S, Shnoda P, Savidge S, Hammond J, Panish J, Wilson M. Reduction in fixation time and related surgical stress with the use of ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device in the deployment of intra-peritoneal onlay mesh (IPOM) for open ventral hernia repair. Paper presented at: ISPOR 16th Annual European Congress;
November 2-6, 2013; Dublin, Ireland.
7. Domain comparisons for surgical stress (Surg-TLX economic model).