Admedus won 510(k) clearance from the U.S. FDA for its CardioCel cardiovascular scaffold.
Perth, Australia and Minneapolis, Minn.-based Admedus is developing implantable regenerative technologies. CardioCel, the company’s 1st product, is a pure collagen, bio-compatible regenerative tissue scaffold.
CardioCel is approved for pericardial closures in the U.S., to repair cardiac and vascular defects in both adults and children. The device is also approved in Europe and will be on the market later this year, according to a press release.
“This is a significant milestone for the company as we expand into global markets and further develop our range of regenerative tissue products for commercialization and sale,” CEO Lee Rodne said in prepared remarks.