Dallen Medical has received FDA 510(k) clearance for a polymer-coated version of its Compressyn™ Band for sternal closure. This clearance follows earlier clearances for its non-coated Compressyn Band and the company’s Compressyn Staple for foot, ankle & hand fixation and repair.
Well, we can’t give you much here I’m afraid. What’s strange, for a company that is going to all the trouble of preparing sequential press releases about its progress, is just how coy it is about showing us the product or indeed telling us why coating it with a polymer (and what polymer?) makes a difference. Nonetheless, it seems like they’re onto something at least in terms of their target market, which represents over 445000 procedures annually in the U.S. alone.
According to David Mills, President and CEO of Dallen Medical, “This clearance reflects Dallen’s response from physicians and marks the expansion of the Compressyn product line. The Compressyn Band offers the best combination of fixation-with-compression at an attractive value to hospitals.”
Al Memmolo, COO, added, “As a permanent implant, the coated Compressyn Band opens the door to offering this polymer coating to future banding technologies.”
Er, great…thanks for the insight.
Source: Dallen Medical Inc., Business Wire