Dallen Medical Reports First-in-Man Use of Compressyn Staple

Officials with San Clemente, Calif.-based Dallen Medical, Inc., a manufacturer of bone fixation and repair technology, reported the first human use of the company’s Compressyn staple. The company claims it is the only rigid compression fixation technology that delivers “continual, dynamic compression for small bone fixation.”

The first procedure was a treatment for an arthritic foot, where the Compressyn staple was used to perform the calcaneal cuboid fusion of a triple arthrodesis. Cleared by the U.S. Food and Drug Administration (FDA) in February 2013, the Compressyn staple is designed for a broad range of foot, ankle and hand fixation, including Jones fracture, Lisfranc dislocations, metatarsal fractures or bunionectomies.

“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 CEO David Mills. “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.”

According to the company, the proprietary, stainless steel Compressyn staple springs into position upon delivery, providing active tension that creates strong, consistent compression. The 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, Dallen officials claim.

The staple can be delivered using a disposable or reusable delivery system.

Dallen Medical is an early-stage orthopedic company with seven FDA clearances around its Compressyn and Tensyn technologies, which provide fixation-with-compression solutions for use in sternal closure, small bone, and sports medicine procedures.