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.
After the sternum is cracked during open-heart surgery, patients require specialized wires to hold the cavity together. Dallen CEO David Mills said the company responded to physician requests in designing the new, coated Compressyn band.