Description
Ventral hernia repair designed to help you†,1-8 — and your patients
Parietene™ DS composite mesh is designed to be placed in an intraperitoneal site by a laparoscopic or open approach. The mesh is composed of a non-absorbable macroporous polypropylene textile on one side and a fully absorbable synthetic film on the other side. A violet marking is positioned on the mesh to help center and orient the mesh.
Parietene™ DS composite mesh is compatible with open and laparoscopic, including robotic-assisted surgical ventral hernia repair procedures.‡,1,9-11
† Based on preclinical study. Animal data are not necessarily indicative of human clinical outcomes.
‡ Do not force the mesh through the trocar. Inappropriate insertion may lead to textile and/or film damage. The mesh equal to 35 × 30 cm is not designed for laparoscopic use. Only for PPDS12, PPDS15, PPDS1510, and PPDS2015 can be used for robotically-assisted hernia surgery.
- Based on internal preclinical test report for design validation T2294CR212, Evaluation performed through users test and questionnaire in a simulated use environment using a porcine model (n = 7 surgeons). September 2016.
- Based on internal surgeon labs for design validation T2294CR208, Report of Marketing VOC. Evaluation performed through users test and questionnaire in a simulated use environment using a porcine model (n = 7). September 2016.
- Based on NAMSA Study 194092, Pilot in vivo study: Parietene™ DS composite mesh versus Physiomesh™* flexible composite mesh competitor in intraperitoneal pig model: macroscopic, histologic, and scanning electronic microscopic (SEM) observations at 4 weeks in a porcine intraperitoneal implantation model (n = 6). December 2016.
- Based on NAMSA Study 212466, Pilot in vivo study: Parietene™ DS composite mesh versus Ventralight™* ST mesh competitor in intraperitoneal pig model: macroscopic and histologic observations at 12 weeks in a porcine intraperitoneal implantation model (n = 6). December 2016.
- Based on NAMSA Study 198929, Minimizing tissue attachment barrier performance, local tissue effects and tissue integration of Parietene™ DS composite mesh in a rat cecal abrasion model: occurrence rates of cecal soft tissue attachment to the mesh through macroscopic observations in the rat (n = 18 test articles vs. n = 18 Ethicon Proceed™* surgical mesh; p < 0.05). October 2016.
- 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. Int J Surg. 2015;22:46–53.
- Ventral Hernia Working Group; Breuing K, Butler CE, Ferzoco S, et al. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010;148(3):544–558.
- Lake SP, Ray S, Zihni AM, Thompson DM Jr, Gluckstein J, Deeken CR. Pore size and pore shape — but not mesh density — alter the mechanical strength of tissue ingrowth and host tissue response to synthetic mesh materials in a porcine model of ventral hernia repair. J Mech Behav Biomed Mater. 2015;42:186–197.
- Based on internal test report RAT207, Robotically assisted laparascopic ventral hernia repair and Parietene™ DS composite mesh. November 2018.
- Based on internal report MDT17051PDS-CSR3, Parietene™ DS composite mesh in ventral hernia repair final clinical study, version 1.0.12. April 2023.
- Based on internal report Herniamed registry extraction: Parietene™ DS composite mesh (Medtronic), F. Kockerling. December 2021.
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