Please note you are entering now content intended only for Healthcare Professionals.
Are you a HCP?
Designed for a better coverage of the myopectineal orifice compared to Bard 3DMax™ and 3DMax™ Light.†,‡,15-17
Provides improved visualization of anatomical structure compared to 3DMax™ thanks to the transparency of the mesh.†,16-18
Ease of use comparable to 3DMax™ in terms of handling: trocar introduction, deployment and positioning.†,§,16,19,20
Item number | Side | Dimensions (cm) | Size | Units per box |
---|---|---|---|---|
DXT1309AL | Left | 13 × 9 | medium | 1 |
DXT1309AR | Right | 13 × 9 | medium | 1 |
DXT1510AL | Left | 15 × 10 | large | 1 |
DXT1510AR | Right | 15 × 10 | large | 1 |
DXT1612AL | Left | 16 × 12 | X-large | 1 |
DXT1612AR | Right | 16 × 12 | X-large | 1 |
Mesh complications may include but are not limited to seroma, hematoma, recurrence, fistula formation, adhesions, infection, inflammation, acute and chronic pain, bowel obstruction, extrusion/erosion.
Do not place the mesh in direct contact with the viscera. Direct contact with the viscera may lead to risks of adhesions, fistula formation and bowel obstruction. Do not implant the mesh in an intra-peritoneal position.
It is recommended not to cut Dextile™ anatomical mesh as it may affect its effectiveness.
† Based on benchtop and preclinical studies. Benchtop and preclinical data are not necessarily indicative of human clinical outcome.
‡ It is recommended not to cut Dextile™ anatomical mesh as it may affect its effectiveness
§ It is recommended to use a trocar of at least 10 mm internal diameter to introduce meshes of size 13 x 09 cm and 15 x 10 cm, and a trocar of at least 11mm internal diameter to introduce a mesh of size 16 x 12 cm. Mesh Insertion capability may vary depending on mesh insertion method, mesh size and graspers/trocars used. Do not force the mesh through the trocar. Inappropriate insertion may lead to textile damage and/or impact self-deployment.
◊ Tissue integration is indirectly assessed with clinical data by the reported low recurrence rates.
¶ compared to 3D Max™*
# compared to Bard 3DMax™ and 3DMax™ Light
†† Based on real world registry data – 361 patients with 1-year follow-up
1. Based on internal test report #43008CR268, Design output file Merlin. February 2019.
2. Cheong KX, Lo HY, Neo JX, Appasamy V, Chiu MT. Inguinal hernia repair: are the results from a general hospital comparable to those from dedicated hernia centres?Singapore Med J. 2014;55(4):191-197.
doi:10.11622/smedj.2014051.
3. Li J, Wang X, Feng X, Gu Y, Tang R. Comparison of open and laparoscopic preperitoneal repair of groin hernia. Surg Endosc. 2013;27(12):4 702-4710. doi:10.1007/s00464-013-3118x.
4. Wittenbecher F, Scheller-Kreinsen D, Rottger J, Busse R. Comparison of hospital costs and length of stay associated with open-mesh, totally extraperitoneal inguinal hernia repair, and transabdominal preperitoneal
inguinal hernia repair: an analysis of observational data using propensity score matching. Surg Endosc. 2013;27(4):1326-1333. doi:10.1007/s00464-012-2608-6.
5. Pisanu A, Podda M, Saba A, Porceddu G, Uccheddu A. Meta-analysis and review of prospective randomized trials comparing laparoscopic and Lichtenstein techniques in recurrent inguinal hernia repair. Hernia.
2015;19(3):355-366. doi:10.1007/s10029-014-1281-1.
6. Yang GP, Chan CT, Lai EC, Chan OC, Tang CN, Li MK. Laparoscopic versus open repair for strangulated groin hernias: 188 cases over 4 years. Asian J Endosc Surg. 2012;5(3) 131-137.
doi:10.1111/j.1758-5910.2012.00138.x.
7. HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12. PMID: 29330835; PMCID: PMC5809582.
8. Singh AN, Bansal VK, Misra MC, et al. Testicular functions, chronic groin pain, and quality of life after laparoscopic and open mesh repair of inguinal hernia: a prospective randomized controlled trial. Surg Endosc.
2012;26(5):1304-1317. doi:10.1007/s00464-011-2029-y.
9. Timiæescu L, Turcu F, Munteanu R, et al. Treatment of bilateral inguinal hernia - minimally invasive versus open surgery procedure Chirurgia (Sueur). 2013; 108(1):56-61.
10.Kockerling F, Bittner R, Kofler M, et al. Lichtenstein Versus Total Extraperitoneal Patch Plasty Versus Transabdominal Patch Plasty Technique for Primary Unilateral Inguinal Hernia Repair: A Registry-based, Propensity
Score-matched Comparison of 57,906 Patients. Ann Surg. 2019;269(2):351-357. doi:10.1097/SLA.0000000000002541.
11.Memorandum 43008CR343-Robotically Assisted Inguinal Hernia Surgery - review considering Dextile Anatomical Mesh.
12.43008CR268a Design Output File Merlin .
13.Based on internal report RE00454986 Herniamed Registry Extraction. Dextile™ anatomical mesh. 1-Year Data (Medtronic). Dr F. Köckerling. March 2023
14.Surgical Product Surveillance PSR Dextile Interim Clinical Study Report December 2022.
15.Based on internal report #43008CR339, Support for marketing claims related to surface of Dextile™ Anatomical Mesh vs competitors. August 2019.
16.Based on internal report #Dextile™ Anatomical Mesh, Surgeon interview report. July 2019.
17.Daes J, Felix E. Critical View of the Myopectineal Orifice. Annals of Surgery 2017;266(1), e1-e2.
18.Based on internal report #43008CR336, Support for marketing claims related to the Dextile ™ Anatomical Mesh transparency. August 2019.
19.Based on internal report #43008CR316a, Evaluation of Dextile™ Anatomical Mesh through human cadaver lab - PRL design validation. July 2019.
20.Based on internal report #43008CR326, Support for marketing claims related to Dextile™ Anatomical Mesh handling. August 2019.
21.Based on Phycher report #IMP-Toxsys-1 month-PH-19-0218 final report. August 2019.
22.Weyhe D, Cobb W, Lecuivre J, et al. Large pore size and controlled mesh elongation are relevant predictors for mesh integration quality and low shrinkage - Systematic analysis of key parameters of meshes in a novel
minipig hernia model - International Journal of Surgery 2015;22: 46-53.
23.Based on internal report RE00454986 Herniamed Registry Extraction. Dextile™ anatomical mesh. 1-Year Data (Medtronic). Dr F. Köckerling. March 2023.
The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).
Please note that the intended use of a product may vary depending on geographical approvals.
See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.
For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.
If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.
Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
Medtronic products placed on European markets bear the CE mark and the UKCA mark (if applicable).
For any further information, contact your local Medtronic representative.