Real-World Performance of the Veriset Hemostatic Patch: A Multicenter Study of Adjunctive Hemostasis

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Purpose: Uncontrolled bleeding remains a major surgical challenge, increasing morbidity, operative time, and costs, highlighting the need for effective adjunctive hemostats. Veriset is a synthetic, absorbable patch that promotes clotting and provides mechanical hemostasis. While early studies show efficacy, real-world evidence across diverse settings is needed. This post-market, multicenter study evaluated the safety and effectiveness of Veriset in various surgical procedures. Methods: This observational, single-arm, prospective study was nested within Medtronic’s product surveillance registry. Sites were selected for procedural diversity (cardiovascular, soft-tissue, solid-organ), high Veriset use, and clinical study experience. Patients treated with Veriset as part of usual care were followed for 30 days post-procedure to monitor adverse events (AEs). The primary safety and effectiveness endpoints were device-related AEs within 30 days and hemostasis within 5 minutes, respectively. Secondary outcomes included time to hemostasis, length of hospital stay, and bleeding-site severity. Results were summarized using descriptive statistics and exact (Clopper–Pearson) confidence intervals. Results: Veriset was used on-label in 100 patients in cardiovascular (56), soft-tissue (18), solid-organ (18), and other (8) procedures. Most were performed via open surgery (90.0%), with 34% involving anastomoses. Median blood loss was 600 mL (interquartile range 200– 1500), with transfusions in 24 patients. Of the 120 bleeding sites treated, pre-Veriset methods included sutures (55.8%, 67/120) and pressure (29.2%, 35/120). Bleeding was mostly mild/moderate (82.5%, 99/120). Device-related AEs occurred in 1 patient, with no deaths. Hemostasis within 5 minutes was achieved at 91.7% (110/120) of sites and in 96.0% (96/100) of patients. Median time to hemostasis was 2.0 minutes; median hospital stay was 7 days. Conclusion: This study provides real-world evidence that Veriset is safe and suggests that it may be an efficacious and rapid adjunct for surgical hemostasis, including in high-risk cardiovascular and solid-organ procedures, supporting and extending prior trial data for routine clinical use. Clinicaltrials.gov Identifier: NCT01524276, Dec 24, 2025. Plain-language summary: Uncontrolled bleeding during and after surgery can cause complications, make surgeries longer, and increase healthcare costs. Researchers wanted to see if the Veriset hemostatic patch could help stop bleeding quickly in real-world surgeries. The Veriset patch is made from materials that form a gel that initiates the clotting process to stop bleeding. The patch breaks down and disappears in the body after about a month. To test the patch, researchers collected information from 100 people who had different types of surgery, including cardiovascular, soft-tissue, and solid-organ procedures. They checked how fast the patch stopped bleeding and whether there were any complications associated with the use of the patch. The study found that Veriset stopped bleeding within five minutes for 96 out of the 100 patients, with most bleeding stopped in about two minutes. The study also checked for any complications related to the use of Veriset. Only one person had a problem that may have been connected to the procedure and the patch, which was successfully managed with medication. There were no complications linked only to the use of Veriset. These results suggest that the Veriset patch is a safe and effective way to control bleeding during surgery. Its fast action, simple use, and performance in high-risk cases could help people recover better and may reduce the need for blood transfusions. Keywords: bleeding, surgery, topical hemostat

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