ACell's Gentrix® Surgical Matrix Provides Exceptional Long-Term Results in Complex Patient Populations for Durable Reinforcement of Ventral Hernias
New data series published in the journal Hernia
COLUMBIA, Md., Oct. 8, 2018 /PRNewswire/ -- ACell, Inc. today announced that impactful data focused on its Gentrix Surgical Matrix family of devices for use in ventral hernia repair was published ahead of print in the peer-reviewed journal Hernia. Gentrix Surgical Matrix devices are a biologically-derived reinforcement material, comprised of ACell's proprietary MatriStem UBM™ (Urinary Bladder Matrix) technology, which may be utilized for a variety of complex hernia and abdominal wall repairs.
The article, entitled "Long-term clinical, radiological, and histological follow-up after complex ventral incisional hernia repair using urinary bladder matrix graft reinforcement: a retrospective cohort study," was authored by Kent Sasse, MD of the University of Nevada, Reno. The study – examining 64 patients with ventral hernias that had been repaired and reinforced with Gentrix Surgical Matrix devices – calculated a recurrence rate of 4.0% and 15.6% at a 24 and 36 month median follow-up time, respectively. As a comparison, several recently published studies with a similar population show recurrence rates of 31.8% at 18 months1 and 17% at 24 months2. In addition, the study includes histological and radiographic evidence demonstrating long-term, robust fascial repairs with remodeling of site-appropriate tissue, as opposed to scar tissue.
"Clinicians have yet to find the ideal hernia reinforcement mesh," said Dr. Sasse. "There are a number of materials that may solve an immediate problem in the short term, but as seen in these long-term histological findings, there is a uniquely vigorous, exuberant remodeling response after implantation of the Gentrix devices that appears to translate to longer term strength and durability of the hernia repair."
"This case series is differentiated by not only its long-term follow up, but by the complex nature of many of the cases studied, 84% of which were classified as major in the Slater patient severity classification system," said Thomas A. Gilbert, PhD, Chief Science Officer. "In addition, the complication rates in a number of areas including recurrence, seromas, and major wound care events were lower than in other recently published studies."
"We are very pleased to present these significant, long-term results, and especially encouraged by the histological and radiographic data demonstrating the remodeling of robust, long-term, biomechanically functional tissue," said Patrick McBrayer, President and CEO. "ACell's objective is to meet the needs of clinicians and patients with safe, cost-efficient, and clinically effective devices for complex hernia repair, and the growing body of research focused on our Gentrix Surgical Matrix devices is an important driver for advancing that goal."
Sasse KC, Lambin JH, Gevorkian C, Elliott R, Gardner A, Mehta A, Lambin R, Peraza L. Long-term clinical, radiological, and histological follow-up after complex ventral incisional hernia repair using urinary bladder matrix graft reinforcement: a retrospective cohort study. Hernia. 2018 Oct 1. doi: 10.1007/s10029-018-1830-0
To access the full article, visit www.acell.com/complexhernia.
About ACell, Inc.
ACell, Inc. is a leading regenerative medicine company focused on the development, manufacturing, and commercialization of medical devices for wound management and surgical soft tissue repair. ACell is committed to becoming and remaining an innovative leader in regenerative medical technology, offering superior healing options for doctors and patients. ACell is a privately held company and operates manufacturing facilities in Columbia, MD and Lafayette, IN.
About Gentrix Surgical Matrix
Gentrix Surgical Matrix devices are biologically-derived Extracellular Matrices (ECMs) designed for use in complex hernia repairs and abdominal wall reconstruction. Unlike synthetic mesh, these devices are completely resorbable, leaving no permanent foreign body. Gentrix Surgical Matrix devices are minimally processed, minimizing foreign body response and facilitating cellular infiltration, resulting in the remodeling of site-appropriate, biomechanically functional tissue.
1 Huntington C, Cox T, Blair L, Schell S, Randolph D, Prasad T, Lincourt A, Heniford B, Augenstein V. Biologic mesh in ventral hernia repair: Outcomes, recurrence, and charge analysis. Surgery. 2016 Dec; 160(6):1517-1527. doi: 10.1016/j.surg.2016.07.008.
2 Rosen M, Bauer J, Harmaty M, Carbonell A, Cobb W, Matthews B, Goldblatt M, Selzer D, Poulose B, Hansson B, Rosman C, Chao J, Jacobsen G. Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study. Annals of Surgery. 2017 Jan; 265(1):205-211. doi: 10.1097/SLA.0000000000001601.
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SOURCE ACell, Inc.