Medeon Biodesign Announces Approval to Begin CE Clinical Study for the XProTM Large Bore Vascular Closure System
TAIPEI, May 2, 2017 – Medeon Biodesign, Inc., a Taiwan publically traded medical device company, is pleased to announce today that it has received approval by the Health and Disability Ethics Committees, Ministry of Health, New Zealand to commence the CE clinical trial for the XProTM Suture-Mediated Vascular Closure Device System (XProTM 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 XProTM 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.
XProTM 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 hemostasis 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 XProTM 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 XProTM 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 XProTM 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 CEO of Medeon Biodesign.
About Medeon Biodesign
Medeon Biodesign (TPEx: 6499) is a publicly traded company headquartered in Taipei, Taiwan, and currently listed on Taipei Exchange. The company focuses on the development of medical devices for minimally invasive surgeries to treat diseases of sizable patient population, such as cardiovascular, peripheral vascular, orthopedic, neurosurgery, obesity, gastroenterology, hematology, nephrology, gynecology, urology, and plastic surgery. For more information, please visit www.medeonbio.com/en.
Dr. Yi-Ju Chen
MEDEON BIODESIGN ANNOUNCES INVESTING IN PANTHER ORTHOPEDICS FOR ORTHOPEDIC EXTREMITY APPLICATIONS
TAIPEI, March 28, 2017 – Medeon Biodesign, Inc., a Taiwan medical device company, is pleased to announce that the Company led and successfully closed the Series A investment of Panther Orthopedics, Inc., a San Jose, CA start-up pioneering innovative dynamic fixation solutions for orthopedic extremity applications.
The orthopedic extremity device market continues to expand rapidly, primarily due to procedure volume growth, lifestyle influences and favorable demographics. Nevertheless, the market need for better fixation products for both trauma and sports medicine in fracture fixation and joint stabilization applications is still under served. “Current options for fixation include cortical screw and suture button flexible fixation devices. However, many limitations associated with currently marketed products are not being addressed,” said Dr. Kathryn Stecco, CEO and co-founder of Panther Orthopedics. “We have developed an innovative platform for dynamic extremity fixation, which we believe will provide continuous compression during the healing period while still allowing micromotion. The intuitive design of our solutions is easy to use and intended to eliminate the need for most second surgery removal, providing significant benefits for both the patients and the entire healthcare system.”
"We are excited to lead the investment of Panther Orthopedics to address the long-standing need of better clinical fixation during the healing period for orthopedic extremity applications," said Dr. Yue-Teh Jang, CEO of Medeon Biodesign. “We are impressed with the team’s extensive experience, profound knowledge of orthopedic applications and broad KOL networking. We are confident that the Panther Orthopedics’ unique and innovative dynamic fixation solutions will be very welcome by the clinical community in the near future.”