LifeNet Health has over 30 years of experience in tissue processing and holds the longest-running accreditation with the American Association of Tissue Banks (AATB).1
Sterility assurance level (SAL) 10-6 and ready to use - no rinsing required.
Dermacell is decellularized using Matracell, a proprietary and patented technology that removes at least 97% of donor DNA without compromising the desired biomechanical structure or biochemical properties for its intended use.2
After being rendered acellular, Dermacell undergoes a terminal sterilization step to ensure a Sterility Assurance Level (SAL) of 10-6.
Low-dose gamma irradiation performed at ultra-low temperatures is used to reach surgical device-grade sterility, which lowers the probability of an active organism in the graft to 1 in 1,000,000.2
As a committed partner to hospitals and healthcare practitioners, we strive to provide innovative solutions for surgery and offer two promises with SPY and Dermacell. The SPY Promise provides replacement tissue at no cost if a revisionary surgery is required following simultaneous use of both SPY Fluorescence Imaging and Dermacell products. We also offer the No Red Breast Promise which grants a credit for Dermacell used in patients if they develop red breast syndrome following reconstruction surgery.†
Sterility assurance level (SAL) 10-6.2
Ready to use (RTU)
No rinsing required.2
≥97% Donor DNA-Free
A proprietary and patented technology that removes at least 87% of donor DNA without compromising the desired biomechanical structure or biochemical properties for its intended use.2
Dermacell provides a medical device-grade sterility assurance level of 10-6 and requires no rinsing prior to application.2 The graft features a wide suture border to further support intraoperative placement.
1. For more information, go page: https://www.lifenethealth.org/about/lifenet-health-advantage"
2. Data on file. CTO #100038 63.00050.01 Rev.10 Dermacell IFU
3. Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrix (ADM) in Breast Reconstruction: The 50/50 Study. Journal of Plastic and Reconstructive Surgery (2017)
4. Capito AE. Tholpady SS. Agrawal H, Drake DB. Katz AJ. Evaluation of host tissue integration, revascularization, and cellular infiltration within various dermal substrates. Ann Plast Surg. 2012:68:495-500
5. Vashi C. “Clinical Outcomes for Breast Cancer Patients Undergoing Mastectomy and Reconstruction with Use of DermACELL, a Sterile, Room Temperature Acellular Dermal Matrix.” Plastic Surgery International, April 2014.
† The parties intend for any discount, credit, rebate and/or other price concession (other than any warranty, including either the SPY Promise and/or the ‘No Red Breast’ Promise) provided to Customer hereunder to be treated as a ‘discount or other reduction in price’ as such terms are defined under the Anti-Kickback Statute. The parties intend for any applicable warranty, including the SPY Promise and/or ‘No Red Breast’ Promise, to satisfy the requirements of the Warranties Safe Harbor, 42 C.F.R. § 1001.952(g). Company and the Customer agree to use their best efforts to comply with any and all requirements imposed upon sellers and buyers, respectively, under 42 C.F.R. s 1001.952(h) and 42 C.F.R. s 1001.952(g), as applicable. In this regard, the Customer may have an obligation to accurately report any discount, credit or replacement product received hereunder in any applicable cost reporting mechanism filled with a federal or state government agency and provide information from Stryker concerning any such discount, credit or replacement product received upon request of such governmental agency.
Credits provided to the Customer in connection with the No Red Breast Promise must be used towards the purchase of another Dermacell Product and may not be assigned, traded, redeemed for cash, or transferred and do not provide any other benefits other than those described in these terms and conditions. The ‘No Red Breast’ Promise and the SPY Promise are both subject to additional terms and conditions as set forth in the Dermacell Promise Program terms and conditions. Stryker has the right to amend these terms and conditions from time to time or terminate the Program in its entirety, or the SPY Promise or the No Red Breast Promise individually, at any time without prior written notice. Notwithstanding the foregoing, the SPY Promise and No Red Breast Promise shall automatically expire, and be of no force or effect, on December 31, 2018.
Dermacell, Matracell and Preservon are registered trademarks of LifeNet Health, Inc.
Lit number: 1000902763 Rev A