Category: Dallen Medical
Dallen Medical earns 510(k) clearance for its next-generation Compressyn Band, responding to physician feedback in the new coated design.
The FDA cleared a next-generation sternum compression band made by California bone repair company Dallen Medical. The company's Compressyn Band, used for breastbone closure, features a new polymer coating that older lines of the Compressyn products lack.
Dallen Medical says 3 patients have already been treated in a 1st-in-man study of its Compressyn sternal closure device.
Early-stage device company Dallen Medical announced a 1st-in-man study of its Compressyn band, a breast-plate wire closure device designed to help stabilize patients after open heart surgery.
After the sternum is cracked during open-heart surgery, patients require specialized wires to hold the cavity together. The Compressyn band aims to provide "significant improvements in rigid fixation-with-compression solutions over current devices," according to a Dallen statement.