TELA Bio® Announces One-Year Data from BRAVO Study of OviTex® Reinforced BioScaffolds for Ventral Hernia Repair
Results from post-market clinical study show no hernia recurrences in 32 patients at one-year follow-up
Data presented at Abdominal Wall Reconstruction Conference in Washington, D.C.
MALVERN, Pa., June 6, 2019 /PRNewswire/ -- TELA Bio®, Inc., a regenerative medicine company leading the development of advanced medical devices for soft tissue reconstruction, today announced that one-year data from the company's post-market BRAVO (BioScaffold Reconstruction of Abdominal wall and Ventral hernia defects with Open or laparoscopic repair) study evaluating OviTex® Reinforced BioScaffolds for the treatment of ventral hernias are being presented at the 11th Annual Abdominal Wall Reconstruction Conference taking place June 6-8, 2019 in Washington, D.C.
In one poster presentation, titled, "Reinforced Biologic Reduces Risk of Recurrence in Ventral Hernia (VHR) Patients: One-Year Data from the BRAVO Ventral Hernia Study," principal investigator George DeNoto III, MD, FACS, director of general surgery at St. Francis Hospital in New York, provided one-year results in the first 32 treated patients evaluated at 12 months post-surgery. No patient has had a hernia recurrence despite 80 percent of patients having one or more factors known to increase the risk of recurrence. Eight patients experienced a surgical site occurrence (SSO). None of these required surgical intervention or implant removal, and healing progressed uninterrupted.
"This analysis shows a lower recurrence rate than those reported in other prospective series," said Dr. DeNoto. "The biomechanical optimization of the repair allowed by the reinforced biologic and its observed resilience against the effects of infection may both contribute to this observation. We look forward to longer follow-up in these and subsequent patients to confirm these findings."
A second poster presentation, titled, "Initial Experience with Reinforced Biologics in Minimally Invasive Ventral Hernia Repair (MIVHR)," reports surgeon experience with OviTex Reinforced BioScaffolds in both open and MIVHR. Among the 26 patients with MIVHR, 100% of surgeons cited OviTex as being easy to place and the average surgeon satisfaction at 30 and 90 days was 9.69/10 and 9.67/10, respectively.
"We are pleased to present updated results from our ongoing BRAVO study and are committed to collecting longer-term data on the use of OviTex Reinforced BioScaffolds to support improved patient care and address the needs of surgeons and healthcare systems," said Maarten Persenaire, M.D., chief medical officer of TELA Bio. "The data continues to show that OviTex products are easy to use in a range of procedures and techniques, including robotic and laparoscopic procedures, and we are especially encouraged by the lack of recurrences seen so far after one year."
About TELA Bio, Inc.
TELA Bio, Inc. is a disruptive regenerative medicine company focused on making advanced medical devices accessible to patients requiring soft tissue reconstruction. The company's products are designed to improve on shortcomings of existing biologics and minimize long-term exposure to permanent synthetic material. TELA Bio's portfolio is supported by high-quality, data-driven science and extensive pre-clinical research that has consistently demonstrated advantages over commercially available products. The company's OviTex Reinforced BioScaffolds for hernia repairs and abdominal wall reconstructions are commercially available in the U.S. and in Europe, and Restella Reconstructive BioScaffolds for reconstructive surgery are commercially available in the U.S. The company is collaborating with leading surgeons to drive rapid product development and establish TELA Bio as a leader in soft tissue reconstruction. To learn more about TELA Bio visit http://www.telabio.com.
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