First-in-Man Studies Completed for Medeon Biodesign's XPro Large-Bore Vascular Closure Device

November 3, 2015—Medeon Biodesign, Inc., a Taiwan medical device company, announced the completion of first-in-man studies for its XPro suture-mediated vascular closure device for closure of 8–21-F femoral access sites.

According to Medeon, XPro devices were successfully deployed in 10 consecutive patients undergoing interventional catheterization procedures using 14–18-F sheaths. The company reported that the devices achieved immediate or rapid hemostasis at the puncture sites with excellent clinical outcome, including fast ambulation and discharge from the hospital, demonstrating the safety and effectiveness of percutaneous large-bore closure using XPro suture-mediated vascular closure devices.

Adrian Ebner, MD, commented in Medeon Biodesign’s press release, “Interventional procedures that involve large-bore access usually require major dissection of tissues, cut down of blood vessels, and surgical repair of the access sites, whereas a percutaneous approach is less traumatic for patients and can achieve faster recovery. A large-bore vascular closure device for percutaneous procedures needs to be safe, rapid closing, and easy to use.”

Dr. Ebner continued, “We have conducted first-in-man clinical studies using XPro suture-mediated vascular closure device and are very pleased with its outstanding performance. I believe this device can be useful in large-bore procedures such as transcatheter aortic valve replacement and endovascular aneurysm repair.” Dr. Ebner is Director of Catheterization Laboratory, Sanatorio Italiano Hospital in Asuncion, Paraguay.

Chao-Yung Wang, MD, from Linkou Chang Gung Memorial Hospital in Taiwan, who has used this device in earlier preclinical studies and reviewed the first-in-man data, commented, “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.”