Medeon Biodesign said today it won approval from the New Zealand Ministry of Health’s Health and Disability Ethics Committees to initiate a clinical trial of its XPro suture-mediated vascular closure device as it seeks CE Mark approval.
The study will examine the safety and effectiveness of the XPro System in facilitating hemostasis in patients undergoing percutaneous endovascular procedures including transcatheter aortic valve implantation, endovascular aneurysm repair, thoracic endovascular aneurysm repair and percutaneous balloon valvuloplasty procedures.
A total of 60 patients will be enrolled in the trial in New Zealand and Australia, according to TaiPei, Taiwan-based Medeon Biodesign.
“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,” principal investigator Dr. Mark Webster of the Auckland City Hospital said in a prepared statement.
“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.” study medical monitor Dr. Kendrick Shunk of the University of California, San Francisco said in a prepared relase.
“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.” CEO Dr. Yue-Teh Jang said in a press release.
Last September, Medeon said it won 510(k) clearance from the FDA for its AbClose laparoscopic port site closure device. The AbClose device is designed as a single use, disposable laparoscopic port site closure device designed to allow for secure single-operator suturing while limiting user variability.