Medeon Biodesign Wins Approval to Begin CE Clinical Study for the Large Bore Vascular Closure System
Taiwan–based Medeon Biodesign has received approval from New Zealand’s Ministry of Health to launch a CE clinical trial for the XPro suture-mediated vascular closure device system, the company's large bore closure device.
The study will assess the safety and effectiveness of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheaths via the common femoral artery, including transcatheter aortic valve implementation , endovascular aneurysm repair, thoracic endovascular aneurysm repair and percutaneous balloon valvuloplasty procedures.
The results will support CE Mark regulatory submission. — Cynthia Jessup