Category: Dallen Medical
Dallen Medical's Tensyn Plug for the treatment of hand and foot injuries wins 510(k) clearance.
The FDA has cleared Dallen Medical Tensyn Plug for the treatment of hand and foot injuries.
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.