Feasibility study of NeoMend,a percutaneous arterial closure device that uses a nonthrombogenic bioadhesive

OBJECTIVE: The aim of this prospective single-center phase I feasibility study was to investigate the safety and efficacy of a novel vascular sealing device, the NeoMend Arterial Closure Device, that uses a bioadhesive after percutaneous endovascular procedures. SUBJECTS AND METHODS: In 26 consecutive patients, the sealing device was deployed at the femoral artery access site immediately after a catheterization procedure using a 6-French (1.91-mm) sheath. Patients were followed up at 24 hr with Doppler sonography of the treated femoral artery puncture site, and at 1 week and 1 month by a telephone interview. RESULTS: Successful hemostasis was achieved with the NeoMend Arterial Closure Device in 21 (88%) of 24 patients. One major complication required surgery: formation of puncture site hematoma and pseudoaneurysm 3 days after the intervention after successful primary hemostasis. Two device failures required crossover to manual compression, which was done without further complications. The mean time to hemostasis was 7.0 +/- 4.5 min. Mean time to ambulation was 6.0 hr. At follow-up, the patients did not report any puncture-site-related complaints. Doppler sonography of the puncture sites revealed three insignificant hematomas of less than 20 mL and patent common femoral vessels without stenoses. CONCLUSION: The NeoMend Arterial Closure Device appears to achieve rapid hemostasis with the potential of early ambulation after arterial punctures with a 6-French sheath. The device is an alternative in situations in which suture- or collagen-mediated devices show high complication rates.