FDA clears Dallen Medical's compression for sternal closure

August 28, 2013 by Sony Salzman

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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"As a permanent implant, the coated Compressyn Band opens the door to offering this polymer coating to future banding technologies," COO Al Memmolo said , in prepared remarks.