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ETHICON SECURESTRAP® Absorbable Strap Fixation Device
ETHICON SECURESTRAP® Absorbable Strap Fixation Device
Market-leading fixation device* delivers greater acute holding strength at various deployment angles with no articulation device needed.1,7 Allows for appropriate tissue capture and penetration at various deployment angles to provide greater holding strength.1
Features & Benefits
Stronger acute fixation at various angles1,2
Appropriate tissue capture and penetration for secure acute fixation at multiple angles.1 Our device has a unique, absorbable “strap” design uses 2 points of fixation to straddle mesh pores and fibers.3 The low-profile strap, minimal surface area leaves minimal foreign material exposed to viscera.4
Greater acute holding at various angles1,2
Each strap deploys with equivalent force, providing reliability.1,2 At 45 and 30 degrees, ETHICON SECURESTRAP™ Fixation Device has a higher median holding strength compared with AbsorbaTack8 (P<0.05).1 At 90, 45, and 30 degrees, ETHICON SECURESTRAP™ Fixation Device has a higher median holding strength compared with SorbaFix** (P<0.05).1
Minimal pain
Proven to get patients back to their lives with minimal pain.5 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.6,9 Shown to be safe with improved symptomatic pain levels and movement limitations in the same 12-month follow-up IHMR study.5,6,9
Supporting Documentation
Product Support
ETHICON SECURESTRAP Absorbable Strap Fixation Device Brochure
ETHICON SECURESTRAP® Absorbable Strap Fixation Device Fact Sheet
ETHICON SECURESTRAP Absorbable Strap Fixation Device Competitive Brochure
ETHICON SECURESTRAP Absorbable Strap Fixation Device Optimized Device Performance Guide
References
*DRG market data from Q1 2020 through Q1 2021, comparing hernia fixation device market share.
**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.
1. Cardinale M, Jacinto G; Cohn S, et al. Comparison of Acute Holding Strength of an Absorbable Strap Fixation Device in Porcine Flank at Various Implantation Angles.
2. Cardinale M. Angle fire competitive test. AST 2010-0199
3. ETHICON SECURESTRAP® Absorbable Strap Fixation Device. Instructions for Use. Ethicon Inc. 2020.
4. 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
5. Doerhoff C, Chudy M, Gauld J et al. Preliminary Outcomes using an absorbable fixation device for mesh fixation. AHS 2013 SECURESTRAP (poster).
6.Redan J, et al. 12-month patient reported outcomes following hernia repair with an absorbable ixation device. International Hernia Mesh Registry. 2016. 7. Early outcomes using an absorbable fixation device for mesh fixation (IHMR data analysis). 2013.
7. As shown in a preclinical model which compared 3 absorbable fixation devices
8. 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.
9. 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.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
© Ethicon US, LLC. 2019.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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Last updated February 20, 2019. The third-party trademarks used herein are trademarks of their respective owners. Data and usage fees may apply. See your carrier for more information.