Medeon Biodesign has announced the successful completion of its first-in-human studies for its XPro suture-mediated vascular closure device, targeting to close 8F-21F femoral access sites.
XPro suture-mediated vascular closure devices were successfully deployed in ten consecutive patients undergoing interventional catheterization procedures using 14F-18F sheaths. The devices achieved immediate or rapid hemostasis at the puncture sites with excellent clinical outcome including fast ambulation and discharge from hospital demonstrating the safety and effectiveness of percutaneous large bore closure using XPro suture-mediated vascular closure devices.
“A percutaneous approach is less traumatic for patients and can achieve faster recovery,” Adrian Ebner, director of the Catheterization Laboratory, Sanatorio Italiano Hospital in Asuncion, Paraguay, “We have conducted first-in-man clinical studies using XPro suture-mediated vascular closure device and are very pleased with its performance. I believe this device can be useful in large bore procedures such as TAVI (Transcatheter Aortic Valve Implantation) and EVAR (Endovascular Aneurysm Repair).”
Chao-Yung Wang, an interventional cardiologists at Linkou Chang Gung Memorial Hospital in Taiwan who has used this device in earlier pre-clinical studies, and reviewed the first-in-man data comments, “I am very pleased to see XPro’s ease of use and very short hemostasis time in this clinical setting, and believe that patients who undergo large bore interventional procedures can benefit from an innovative device like this.”