MALVERN, PA — TELA Bio, Inc. announced that additional data from its BRAVO study were presented virtually as posters at the Americas Hernia Society Annual Meeting.
The first poster titled, “Surgical site infections and occurrences (SSIs & SSOs) after ventral hernia repair (VHR) with reinforced tissue matrix (RTM), 30-day data from the BRAVO study,” demonstrated that ventral hernia repair using OviTex led to a low incidence of surgical site infections and occurrences. Among patients who experienced an SSO or SSI at 30 days, none required surgical intervention or implant removal.
The study consisted of 85 subjects, of which 75% met the criteria for Ventral Hernia Working Group (VHWG) grade 2 or grade 3. Over 50% of the patients were obese, over one-third had undergone a previous ventral hernia repair, and 16% had a history of surgical infections. No patient experienced a hernia recurrence within the first 30-days.
The second poster, “Final outcomes of the initial 20 subjects reaching two year follow up in the BRAVO Ventral Hernia Study,” is the first look at long-term outcomes data for the initial 20 patients who had ventral hernia repair using OviTex.
Among these patients, no patient experienced a hernia recurrence. Five patients experienced an SSO during the two years and none required surgical intervention or implant removal. The make-up of the 20 patients in this long-term data was similar to the previous data set, with over 85% meeting the criteria for VHWG grade 2 or grade 3.
“We continue to be encouraged by the BRAVO Study data presented at this year’s Americas Hernia Society Annual Meeting,” said Antony Koblish, President and CEO of TELA Bio.
“The fact that, to date, no patient analyzed in the study has required subsequent surgical intervention to treat a complication or implant removal highlights the performance of OviTex in a moderate-to-complex ventral hernia patient.
“As the BRAVO study matures, the data continue to support the benefits that OviTex offers and to represent OviTex as an advanced natural repair solution to improve patient care and address surgeon needs.”
TELA Bio, Inc. (Nasdaq: TELA), headquarter in Malvern, PA, is a commercial-stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction.
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