LAS VEGAS — Preliminary data from a first-in-human study show safety and effectiveness of a resorbable vascular sealing system for large bore closure when used in patients undergoing endovascular arterial procedures using larger introducer sheaths.
At VIVA 18, Micah Watts, MD, interventional radiologist at Pennsylvania Vascular Institute, reported data from the first 23 patients at a single site in whom the Large Bore Closer resorbable vascular sealing system (Rex Medical) was used to seal femoral arterial access sites at the completion of percutaneous endovascular procedures performed through 10F to 16F introducer sheaths. The system at this size is not yet approved in the United States, but Watts noted that there is premarket approval for the smaller 5F to 7F introducer range.
The primary safety endpoint — incidence of 60-day access site closure-related major complications, including bleeding requiring transfusion, infection requiring antibiotics, any hospitalization and any ischemia or neuropathic complications — was achieved in all 23 patients, Watts said during the late-breaking clinical trial presentation.
The primary effectiveness endpoint was measured by time to hemostasis after device deployment. Use of the device resulted in instantaneous hemostasis in 74% of procedures, Watts said. Thirteen patients were treated without heparin, with a mean time to hemostasis of 1:02 minutes and instantaneous hemostasis in 10 patients. Ten patients were treated with IV heparin, with a mean time to hemostasis of 2:12 minutes and instantaneous hemostasis in seven patients. In the heparin group, mean activated clotting time at deployment was 218 seconds.
The vascular sealing system consists of two components: a delivery system and a proprietary access sheath. The system is designed to deliver a fully resorbable sealing mechanism, including an IV patch and two extravascular spheres connected to two strands of sutures, to the femoral arterial puncture site. The operator can achieve hemostasis via the patch closing the arteriotomy from inside the puncture, according to information from the company. The patch and the spheres are fully resorbed within 60 days, Watts said. – by Katie Kalvaitis
Watts M. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.
Disclosure: Watts reports no relevant financial disclosures.