Biodesign Hernia Graft

Biodesign Hernia Graft

The Biodesign® Hernia Graft is a non cross-linked, non-dermis biologic graft that is completely remodelled into strong, vascularised patient tissue1-3.

 

 

 

 

 

What is Biodesign?

Biodesign Advanced Tissue Repair products are sourced from porcine small intestinal submucosa (SIS). The material acts as a scaffold that, once implanted, allows host cells to infiltrate and remodel into vascularized tissue1-3. SIS supports one of the harshest environments in the body and rapid cell turnover4.

 

STRENGTH 

Studies have shown long-term strength as the Biodesign Hernia Graft remodels3.

Not only is the graft strong at the time of implant, it is designed to exceed the strength of the normal abdominal wall during the time it is being integrated into the patient’s body. When tissue repair and remodelling have been completed, the resulting tissue is stronger than that which was implanted. This occurs because Biodesign is an inductive scaffold – meaning that it is rapidly invaded by patient cells that reinforce the abdominal wall through the secretion of their own collagen3.

 

REMODELLING

Once implanted in the body, the Biodesign source material helps the patient’s own cells infiltrate the scaffold and remodel the material into natural patient tissue.

Biodesign becomes remodelled by the body over a period of several weeks – letting the body’s own defence mechanisms fight infection naturally.

 

1. Franklin ME Jr, Treviño JM, Portillo G, et al. The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. Surg Endosc. 2008; 22(9):1941-1946.
2. 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.
3. Badylak S, Kokini K, Tullius B, et al. Strength over time of a resorbable bioscaffold for body wall repair in a dog model. J Surg Res, 2001;99(2):282-287.
4. Children’s Hospital Los Angeles. Controlling cell turnover in the intestinal lining. Science Daily. https://www.sciencedaily.com/releases/2016/04/160405182950.htm. Published April 5, 2016. Accessed June 19, 2018. 

The technology behind Biodesign Tissue Repair products has been studied and proven with over 20 years clinical use and safety profile. It is supported by more than 1,500 published articles. More than 500 of those describe use in humans and 10 have more than five years of follow-up data and 30 are RCTs.

The Biodesign Hernia Graft is intended for implantation to reinforce soft tissues where weaknesses exist during ventral hernia repair.

Author(s) Title Publication
Franklin ME Jr, Treviño 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 fields: long-term follow-up. Surg Endosc. 2008;22(9); 1941-1946. View
Gupta A, Zahriya K, Mullens PL, Salmassi S, Keshishian A.  Ventral Herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and Alloderm. Hernia. 2006;10:419-425. View
Nguyen KP, Zotos V, Hsueh EC. Long-term outcome of biologic graft: A case report. J Med Case Rep. 2014;8:255. View
Nockolds CL, Hodde JP, Rooney PS. Abdominal wall reconstruction with components separation and mesh reinforcement in complex hernia repair. BMC Surg. 2014;14:25. View

Intended use: The Cook® Biodesign® Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists during ventral hernia repair. The graft is supplied sterile and is intended for one-time use. Rx ONLY This symbol means the following: CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. MR This symbol means the following: Magnetic Resonance Safe. HERNIA GRAFT This symbol means the following: Hernia Graft. This graft is intended for use by trained medical professionals*.

Contraindications: This graft is derived from a porcine source and should not be used in patients with known sensitivity to porcine material.

Precautions: This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease. Do not resterilize. Discard all open and unused portions of the graft. The graft is sterile if the package is dry, unopened and undamaged. Do not use if the package seal is broken. Discard graft if mishandling has caused possible damage or contamination, or if the graft is past its expiration date. Ensure that graft is rehydrated prior to cutting, suturing, stapling, tacking or loading of the graft laparoscopically. Ensure that all layers of the graft are secured when suturing, stapling, or tacking. Place graft in maximum possible contact with healthy, well-vascularized tissue to encourage cell ingrowth and tissue remodeling. Suturing, stapling, or tacking more than one graft together may decrease graft performance. No studies have been conducted to evaluate the reproductive impact of the clinical use of the graft. Extended rehydration or excessive handling could lead to partial delamination of superficial layers of the graft. Care should be taken when device is placed in infected wounds. Care should be taken to avoid damage to the graft when loading laparoscopically. It is recommended to load through a 10 mm or larger port. If wound is left open, keep graft moist to prevent dryness.

Potential complications: Possible adverse reactions with the use of biologic hernia prostheses may include: adhesion, bowel erosion, bowel obstruction, discharge, fever, fistula formation, hematoma, hernia recurrence, infection/abscess formation, inflammation, pain, premature degradation, seroma formation, and wound dehiscence.

 

*See pack insert for full product information.

 

 

Is Biodesign Hernia Graft available via NHS SC? 

The Biodesign Hernia Graft is available directly through NHS SC or H&R Healthcare at customerservices@hrhealthcare.co.uk.

 

Is Biodesign Hernia Graft covered under HCTED? 

The Biodesign Hernia Graft HCTED coverage is dependent upon local arrangements and negotiation with your CCG. Contact local H&R Healthcare Area Sales Manager for information on coverage.

 

As a healthcare professional, is consignment for the Biodesign Hernia Graft available? 

Contact your local H&R Healthcare Area Sales Manager to discuss future consignment agreements.

 

How do I report a product complaint?

Please contact H&R Healthcare at customerservices@hrhealthcare.co.uk.

 

As a healthcare professional, who is my local contact? 

Contact customerservices@hrhealthcare.co.uk to find your local H&R Healthcare representative.

 

 

Effective 1st April 2019, Cook Medical transferred sales support of Hernia Graft products to H&R Healthcare.

Size Product code NHS code
10 x 10cm C-SLH-8H-10X10-2 FVQ2125
13 x 15cm C-SLH-8H-13X15-2 FVQ1781
13 x 22cm C-SLH-8H-13X22-2 FVQ2228
20 x 20cm C-SLH-8H-20X20-2 FVQ1827
20 x 30cm C-SLH-8H-20X30-2 FVQ1828

Biodesign Hernia graft will continue to be available through all existing channels including NHS Supply Chain and product codes will remain the same.

Cook Biotech will continue to manufacture the product and provide clinical and regulatory support.