The Biodesign® range of tissue grafts are used for implantation to reinforce soft tissue where weakness exists. Indications for use include the repair of a hernia or body wall defect. The graft is supplied sterile and is intended for one-time use. This device is not intended for use in urological or gynaecological procedures.
Biodesign grafts encompass the biological properties of porcine small intestinal submucosa (SIS). SIS provides a natural scaffold that allows the body to restore itself through the complex natural process of tissue remodelling. Tissue remodelling involves the recruitment of cells, the renewal of tissue composition, and the reinforcement of structural tissue architecture.¹ As the body heals, SIS is gradually remodelled and integrated into the body, leaving behind organised tissue that provides long-term strength. 2-4
Biodesign tissue grafts are made from an extracellular matrix that contains no meaningful amount of elastin,5 allowing new blood vessels to grow into the open structure.6
The technology behind Biodesign tissue-repair products is supported by more than 1,600 total publications. More than 650 of those describe clinical use and 10 of those have more than five years of follow-up data*.
1.Turner NJ, Badylak SF. Biologic scaffolds for musculotendinous tissue repair. Eur Cell Mater. 2013;25:130-143.
2. Franklin ME Jr, Trevino JM, Portillo G, Vela I, Glass JL, Gonzalez JJ. The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated field: Long-term follow-up. Surg Endosc. 2008;22(9):1941-1946.
3. Stelly M, Stelly TC. Histology of CorMatrix bioscaffold 5 years after pericardial closure. Ann Thorac Surg. 2013;96(5):e127-e129.
4. Badylak S, Kokini K, Tullius B, Whitson B. Strength over time of a resorbable bioscaffold for body wall repair in a dog model. J Surg Res. 2001;99(2):282-287.
5. Heise RL, Ivanova J, Parekh A, Sacks MS. Generating elastin-rich small intestinal submucosa-based smooth muscle constructs utilizing exogenous growth factors and cyclic mechanical stimulation. Tissue Eng Part A. 2009;15(12):3951-3960.
6. Nihsen ES, Johnson CE, Hiles MC. Bioactivity of small intestinal submucosa and oxidized regenerated cellulose/collagen. Adv Skin Wound Care. 2008;21(10):479-486
* Data as of December 2020