Medeon Biodesign Announces Successful First-in-man Studies for Large Bore Vascular Closure Device
TAIPEI, Taiwan, Nov. 3, 2015 /PRNewswire/ — Medeon Biodesign, Inc. (TWSE: 6499), a Taiwan medical device company, is pleased to announce that the Company has successfully completed first-in-man studies for its XPro™ suture-mediated vascular closure device, targeting to close 8F-21F femoral access sites.
XPro™ suture-mediated vascular closure devices were successfully deployed in ten consecutive patients undergoing interventional catheterization procedures using 14F-18F sheaths. The devices achieved immediate or rapid hemostasis at the puncture sites with excellent clinical outcome including fast ambulation and discharge from hospital demonstrating the safety and effectiveness of percutaneous large bore closure using XPro™ suture-mediated vascular closure devices.
“Interventional procedures that involve large bore access usually require major dissection of tissues, cut down of blood vessels and surgical repair of the access sites, whereas a percutaneous approach is less traumatic for patients and can achieve faster recovery,” said Dr. Adrian Ebner, a world renown interventional cardiologist and Director of Catheterization Laboratory, Sanatorio Italiano Hospital in Asuncion, Paraguay, “A large bore vascular closure device for percutaneous procedures needs to be safe, rapid closing and easy to use. We have conducted first-in-man clinical studies using XPro™ suture-mediated vascular closure device and are very pleased with its outstanding performance. I believe this device can be useful in large bore procedures such as TAVI (Transcatheter Aortic Valve Implantation) and EVAR (Endovascular Aneurysm Repair).”
Dr. Chao-Yung Wang, an interventional cardiologists at Linkou Chang Gung Memorial Hospital in Taiwan who has used this device in earlier pre-clinical studies and reviewed the first-in-man data commented “I am very pleased to see XPro™’s ease of use and very short hemostasis time in this clinical setting, and believe that patients who undergo large bore interventional procedures can benefit from an innovative device like this.”.
“Besides TAVI and EVAR, other interventional procedures that require large bore access also include Thoracic Endovascular Aortic Repair (TEVAR), Transcatheter Mitral Valve Repair (TMVR), Percutaneous Balloon Valvuloplasty (PBV), and Percutaneous Ventricular Assist Device (pVAD). XPro™ addresses the need of a rapidly growing market.” says Dr. Yue-Teh Jang, CEO of Medeon Biodesign. “Currently, there are very limited device options indicated for large bore access sites and many improvement opportunities for currently marketed devices. We believe that the XPro™ suture-mediated vascular closure device can provide a new choice for interventionalists and patients worldwide.
MEDEON BIODESIGN RECEIVES FDA 510(K) CLEARANCE FOR CLICKCLEAN™ – LAPAROSCOPE LENS SHIELD DEVICE
LOS ALTOS, Calif and TAIPEI, – August 25, 2015 /PRNewswires/ – Medeon Biodesign, Inc., a Taiwan medical device company, is pleased to announce that the company has received U.S. Food and Drug Administration 510(k) clearance for ClickClean™, a lens cleaning device. ClickClean provides instant, in-situ, one-click lens cleaning during laparoscopic procedures, which virtually eliminates the need to remove the laparoscope from the body cavity during surgery and significantly reduces the total time, cost, risks and repeated frustration associated with maintaining a clear visual field.
“Impaired vision due to a soiled lens routinely occurs in nearly every surgery. A soiled lens is one of the disadvantages and most prominent frustrations in performing laparoscopic surgery,” said Dr. Thomas Hsu, the original inventor of ClickClean and an urologist at Kaiser Permanente Santa Clara Medical Center, California as well as a Consulting Professor of Urology at Stanford University School of Medicine. “Based on its elegant design to achieve easy and instant lens cleaning, ClickClean could eliminate nearly all of the surgical delays, risks and frustrations associated with existing techniques for laparoscopic lens cleaning.”
“ClickClean is a single-use, disposable accessory for laparoscopic surgery, which uses a transparent film to shield the lens from blood, fat, smoke and debris during the surgery by simply clicking a trigger on the device and immediately replacing the soiled film with a segment of new and clean film. It is estimated that 2.8 million laparoscopic procedures are performed in the US and approximately 7.5 million procedures are performed worldwide each year. ClickClean addresses the unmet need of virtually every laparoscopic surgery.” says Dr. Yue-Teh Jang, CEO of Medeon Biodesign.