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FDA clears Dallen Medical's compression for sternal closure

Wed, 08/28/2013 - 10:29am
Mass Device

Dallen Medical earns 510(k) clearance for its next-generation Compressyn Band, responding to physician feedback in the new coated design.

FDA clears Dallen Medical's compression band to repair bones

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.

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