Medeon Biodesign Receives FDA 510(k) Clearance for Abclose™ – Laparoscopic Port Site Closure Device
TAIPEI, Taiwan, Sept. 19, 2016 /PRNewswire/ — Medeon Biodesign, Inc., a Taiwan medical device company, announces today that the company has received U.S. Food and Drug Administration 510(k) clearance for AbCloseTM, a single use, disposable laparoscopic port site closure device. AbCloseTM is a revolutionary advancement in port site closure technology that enables fast, simple, and secure single-operator suturing and eliminates the majority of user variability.
“AbCloseTM is designed to reduce time, cost, and risk of port site closure and minimize the frustrations experienced by surgical teams at the end of the surgical procedure. AbCloseTM enables secure and precise delivery of 180-degree suture bites on fascia of nearly all thicknesses. 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. AbCloseTM addresses the unmet need of virtually every laparoscopic surgery,” said Dr. Yue-Teh Jang, Chairman and CEO of Medeon Biodesign.
“Port site hernias are sometimes difficult to diagnose and repair, and the best approach is preventative. Thus, there is a significant clinical need for safe, rapid, and reliable large port site closure in prevention of hernias. AbCloseTM provide a predictable solution to allow surgeons to quickly, precisely, and securely suture trocar sites in under a minute. It functions similarly to a sewing machine and provides air-tight closure with predictive suture return,” said Dr. Harcharan Gill, Professor of Urology at Stanford at Stanford University School of Medicine.
“Complications of port site hernias can result in incisional pain or bowel strangulation, causing significantly longer recovery time and increased treatment cost to patients and hospitals,” said Dr. Kirby Tran, a practicing Obstetrician & Gynecologist in Mountain View, California. “AbCloseTM requires minimal training, and significantly reduces the total time, cost, risks, and frustration associated with ineffective port site closure. AbCloseTM is very simple to use.”