FDA Awards Clearance to OptMed Topical Skin Adhesive
OptMed has raked in 510(k) clearance for its BondEase topical skin adhesive — designed for the closure of surgical incisions and lacerations — as an alternative to sutures and staples.
A biocompatible product, BondEase is the first tissue adhesive for the topical approximation of skin adhesive that is not based on cyanoacrylate chemistry, the company says.
The device was tested in a 162-patient clinical trial with primary endpoint of the incidence of 100 percent wound closure at 10 days.
OptMed expects the product to be commercially available to healthcare providers in late 2016. — Michael Cipriano