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

Abstract

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. 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. 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. 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.