Features & Benefits
Our core understanding of the principles of tissue engineering has led to the development of products that are highly differentiated. Our products provide unique and compelling benefits to physicians, hospital facilities, and patients alike. The table below provides a summary of these features and benefits.
|Broad clinical application||Our fetal/neonatal bovine acellular dermal matrix technology has been used worldwide in hernia repair and plastic and reconstructive surgery.|
|Non-Inflammatory – Non-Irritant||SurgiMend is made of Type I and Type III collagen; and is without preservatives, denatured proteins, artificial chemical crosslinks, cells, lipids, carbohydrates and other constituents, all of which can induce inflammation.|
|Abundant levels of Type III collagen||SurgiMend’s source tissue is fetal/neonatal bovine dermis, which contains three times more Type III collagen than other acellular dermal matrices (such as those derived from cadaveric adult human or other adult animal tissues).|
|Highly porous||Upon implantation, the highly porous matrix soaks with blood, acting as a sponge to trap cells and growth factors (including VEGF) to seed the matrix. The matrix is rapidly revascularized.|
|Bovine source material||The biological make-up of bovine dermis, including its inherent collagen fiber architecture, leaves SurgiMend unmatched in available thicknesses and mechanical strength.|
|Variety of thicknesses, including: 1.0, 2.0, 3.0, and 4.0 mm.
(Range: 0.2 – 4.3 mm.)
|Optimized repair choices: Most appropriate device thickness, strength, and size for each procedure, technique, and patient.
Strength: Strongest biologic matrix available. Thicker products are stronger products and are the best choice to strengthen and reinforce the repairs required in the most challenging cases.
|Variety of sizes up to 25 cm x 40 cm.||Reduces the need to quilt smaller pieces, avoiding vulnerable suture lines and leading to savings in operating room time and cost.|
|Rapid rehydration (60-120 seconds).||More efficiency/flexibility during surgical procedures.|
|Flexible & strong natural tissue properties.||Excellent handling and suturing.|
|Derived from only well-defined and characterized source tissue with respect to age, mechanical strength, structure, and composition.||Young, healthy tissue of consistent thickness, predictable handling and application.|
|Terminally sterilized. 10-6 SAL (Sterility Assurance Level)||Reduces risk of transmission of blood-borne pathogens, transmission of disease.|
|Contains no potentially antigenic antibiotics.||No need for extensive rinsing leads to operating room time and cost savings. Device does not put patient at risk for potential allergies to antibiotics. Non-irritant.|
|Contains no Polysorbate 20 (cell lysing product/preservatives).||No need for extensive rinsing leads to operating room time and cost savings. Device does not put patient at risk for potential allergies to Polysorbate 20. Non-irritant.|
|ISO 13485/cGMP quality manufacturing facility.||Safe and highly consistent products.|
|Up to 5-year room temperature storage.||Cost savings, flexibility and convenience. No need for special refrigerated storage.|
|Product is a medical device, not a Tissue Bank product.||No need for tracking as a tissue-banked product.|