Medeon Biodesign wins FDA 510(k) for AbClose

Taiwanese medical device company Medeon Biodesign said yesterday that it won 510(k) clearance from the FDA for its AbClose laparoscopic port site closure device.

The AbClose device is designed as a single use, disposable laparoscopic port site closure device designed to allow for secure single-operator suturing while limiting user variability.

“AbClose 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. AbClose enables secure and precise delivery of 180° 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. AbClose addresses the unmet need of virtually every laparoscopic surgery,” chairman & CEO Dr. Yue-Teh Jang said in a press release.

“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. AbClose 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,” added Dr. Harcharan Gill of  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. AbClose requires minimal training, and significantly reduces the total time, cost, risks, and frustration associated with ineffective port site closure. AbClose is very simple to use,” obstetrician & gynecologist Dr. Kirby Tran said in a prepared statement.

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