First-Ever Use of Compressyn Staple

Small bones, rejoice…things are on a roll with a new rigid compression fixation technology from Dallen Medical, Inc. The company has just announced the first human use of its FDA-cleared Compressyn Staple, which, as noted by Dallen, is “the only rigid compression fixation technology that delivers continual, dynamic compression for small bone fixation.”

In this first-in-human procedure the patient was treated for an arthritic foot; the Compressyn Staple was used to perform the calcaneal cuboid fusion of a triple arthrodesis.

“Our next generation staple system improves upon the drawbacks of nitinol and other stainless steel staples to deliver more consistent, dynamic compression designed to improve patient outcomes, ” said Dallen Medical Chief Executive Officer David Mills in the September 18, 2014 news release. “This first-in-man milestone demonstrates that we are continuing to execute well as a company, with a strong track record of regulatory and clinical success.”

The news release states, “The proprietary, stainless steel Compressyn Staple springs into position upon delivery, providing active tension that creates strong, consistent compression. The Compressyn Staple is more rigid than nitinol staples, minimizing the risk of splaying and improving patient outcomes, which may reduce treatment costs and length of hospital stay. The unique staple design also virtually eliminates distraction, which has been an issue with competitive stainless steel staples.” The Compressyn Staple is flexible in that it can be used with a disposable or a reusable delivery system.

Mills told OTW, “Dallen Medical is focused on areas where it can deliver a higher standard of fixation without compromising speed or ease of use. As such, we are adding to our extremities portfolio and plan to commercialize our Tensyn band for syndesmosis repair within the next two months. From there, we will build out the Tensyn band platform and have already identified a number of applications and product line extensions.”

“Within the next year, Dallen Medical will have its patented technology that provides superior fixation and compression commercialized in three product lines, with a number of line extensions working their way through the FDA pipeline towards commercialization.”