The XPro device is designed for vascular closure following transcatheter aortic valve replacement, endovascular aneurysm repair, thoracic endovascular aneurysm repair and percutaneous balloon aortic valvuloplasty procedures. Medeon said it plans to continue working with Terumo on future technical, clinical and regulatory developments for the system.
In May 2017 Medeon won approval in New Zealand for a clinical trial of the XPro suture-mediated vascular closure device to back its bid for CE Mark approval. Today the company said the study, which is also under way in Australia and Taiwan, showed that XPro achieved “immediate or rapid hemostasis” at femoral puncture sites for introducer sheaths ranging from 8FR to 18Fr “with excellent clinical outcomes, including fast ambulation and discharge from hospitals.”
“Access site complications in large bore procedures remain to be a significant concern among practicing clinicians. Leveraging the advantages of the security of suture-mediated closure and built-in safety mechanisms, the closure system provides a better solution for the large bore procedures with excellent outcomes and rapid hemostasis. We are pleased that the closure system’s unique and innovative technology complements Terumo’s vascular closure device portfolio, and we look forward, together with Terumo’s strong expertise in product development and commercialization, to accelerating the time to market of the closure system in the emerging large bore market and driving further innovation into the hands of healthcare providers,” Medeon chairman & CEO Dr. Yue-Teh Jang said in prepared remarks.
Medeon shares closed up 10.0% today in Taipei, at T$93.70 apiece (about $3.20).
($1 = T$29.3241)