Clinical data on the Zenapro® Hybrid Hernia Repair Device is now published in the journal Surgical Endoscopy.
You can read the study here.
This clinical study followed 63 patients who had a ventral-hernia repair procedure. These patients had a mean BMI of 34.5 kg/m2, and most of them had at least one comorbidity. Many patients had a history of smoking. There were four recurrences. One year after the procedure, 55 patients were available for follow-up.
According to the study, Zenapro had a recurrence rate of 7.3% at one year follow-up.
Brent, a Cook Surgery global product manager, was not surprised by these results. “Zenapro is a hybrid, which means it’s a combination of two components,” he says. “Those components are polypropylene and a biomaterial called small intestinal submucosa (SIS). Polypropylene is already trusted by many surgeons. And, the biomaterial has been used in our products, like the Biodesign Hernia Graft, for more than a decade. We aren’t surprised to see that the combination of polypropylene and SIS is associated with an acceptable recurrence rate.”
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Note: After accounting for the patients that were lost to follow up, the recurrence rate was updated to 7.3% in the erratum of the paper.
Bittner JG 4th, El-Hayek K, Strong AT, et al. First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial. Surg Endosc. 2017. doi: 10.1007/s00464-017-5715-6.