Medeon Biodesign, a Taiwan publically traded medical device company, has received approval from the Health and Disability Ethics Committees, Ministry of Health, New Zealand to commence the CE clinical trial for the XPro Suture-Mediated Vascular Closure Device System (XPro System), the company’s large bore closure device, at Auckland City Hospital in New Zealand.
The clinical 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 (TAVI), Endovascular Aneurysm Repair (EVAR), Thoracic Endovascular Aneurysm Repair (TEVAR), and Percutaneous Balloon Valvuloplasty (PBV) procedures. The prospective, multi-center, single arm study will enroll up to 60 patients in New Zealand and Australia. The results will support CE Mark regulatory submission.
XPro System, the innovative suture-mediated closure device targeting percutaneous large bore procedures, had its safety and effectiveness demonstrated in first-in-man studies in late 2015 at Sanatorio Italiano Hospital in Asuncion, Paraguay. The device achieved immediate or rapid haemostasis at the puncture sites with excellent clinical outcomes, including fast ambulation and discharge from the hospital.
Dr. Mark Webster, an interventional cardiologist at Auckland City Hospital, who is also the principal investigator of this clinical study, stated “As TAVI procedures expand to intermediate and low risk patients, reducing all peri-procedural 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.”
“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 pre-closure solutions. Suture based pre-closure 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.” notes Dr. Kendrick Shunk, an Interventional Cardiologist TAVI operator and Professor of Medicine at University of California, San Francisco, who also serves as a clinical advisor to Medeon Biodesign and Medical Monitor for this CE study.
“Optimal large bore vascular closure can be achieved by three simple steps with the XPro System. Our suture mediated technology with built-in safety mechanisms is designed to assist interventionalists to manage procedures more efficiently while minimize potential complications associated with vessel narrowing and concerns arising from other technologies that leave behind foreign materials in the blood vessel. The commencement of this clinical study will accumulate more clinical experience to demonstrate its safety, effectiveness, and reproducibility of this disruptive technology.” says Dr. Yue-Teh Jang, chairman and chief executive officer of Medeon Biodesign.