Clinical Study Begins for CE Mark Approval of Medeon's XPro Large-Bore Vascular Closure System

May 2, 2017—Medeon Biodesign, Inc. announced that it has received approval by the New Zealand Ministry of Health's Health and Disability Ethics Committees to commence the CE Mark clinical trial for the XPro vascular closure device system. The prospective, multicenter, single-arm study will enroll up to 60 patients in New Zealand and Australia. The results will support regulatory submission for CE Mark approval.

According to the company, the XPro is a suture-mediated closure device for percutaneous large-bore procedures. The clinical study will assess the safety and effectiveness of the XPro system to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8- to 18-F introducer sheaths via the common femoral artery.

In late 2015, the safety and efficacy of the XPro system was first demonstrated in first-in-man studies at Sanatorio Italiano Hospital in Asunción, Paraguay. The device achieved immediate or rapid hemostasis at the puncture sites with excellent clinical outcomes, including fast ambulation and discharge from the hospital, stated Medron Biodesign.

Mark Webster, MD, an interventional cardiologist at Auckland City Hospital in Auckland, New Zealand, serves as the Principal Investigator of this clinical study.

In the company's announcement, Dr. Webster commented, "As [transcatheter aortic valve replacement] procedures expand to intermediate- and low-risk patients, reducing all periprocedural complications assumes greater importance. Access site complications from large-bore vascular sheaths and valve delivery systems remain a concern and are still a common cause of patient morbidity and, very occasionally, mortality. A dedicated, large-bore vascular closure device with reproducible safety and efficacy has the potential to significantly lower the time, effort, and expense of these procedures, as well as improve patient outcomes."

Kendrick Shunk, MD, who serves as Medical Monitor for this CE Mark study, commented, "I am very pleased to have witnessed the development of the XPro system from its early conception to its present form. The system is easy to use and has certain distinct features and potential advantages over currently available preclosure solutions. Suture-based preclosure techniques allow physicians to optimize control over percutaneous large-bore access site hemostasis, and the XPro system's novel suture deployment mechanism has the potential to enhance safety, minimize risk of iatrogenic vessel narrowing, and shorten procedure time." Dr. Shunk is an interventional cardiologist and Professor of Medicine at University of California, San Francisco in San Francisco, California.