Bone fixation and repair specialist company Dallen Medical, Inc., has announced the first human use of its Compressyn™ Staple, the only rigid compression fixation technology that delivers continual, dynamic compression for small bone fixation.
Background
Back in July we covered the FDA’s clearance to market of Dallen Medical’s Compressyn Staple for use in small bone fixation. As a quick reminder, this is the clever concept that works by delivering what the company calls active tension by virtue of its combination of rigidity and sustained compression. The proprietary, stainless steel Compressyn Staple springs into position upon delivery and 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.
Dallen Medical says the Compressyn Staple can be delivered either with its affordable disposable delivery system, which provides one-step staple delivery and compression, or its reusable delivery system.
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. FDA-cleared 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.
Company comments
“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. “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.”
Source: Dallen Medical, Inc.
