New Zealand OKs CE Mark trial for Medeon Biodesign ’ s XPro large-bore vascular closure device

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 i...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Regulatory/Compliance Vascular Medeon Biodesign Source Type: news