US-based Dallen Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its individually packaged, sterile Compressyn staple implants.
According to Dallen Medical, the company’s patented Compressyn technology offers significant improvement over existing products by delivering superior fixation with compression in sternal closure, small bone, and sports med applications.
This should result in better patient outcomes, resulting in cost savings and reductions in length of stay.
Dallen Medical president and CEO David H Mills noted this clearance allows the company to offer physicians the highest level of rigidity and compression with its proprietary Compressyn Staple, but also at a price point to meet every hospital and surgery center’s budget.
"In the last twelve months, Dallen has received three FDA clearances and initiated commercialization of its first product, the Compressyn Band for sternal closure. These milestones have positioned the company for what we expect will be an exciting 2014," Mills said.
Previously, the company has obtained the FDA approval for its Tensyn band for syndesmosis repair.
With the two approvals, the company has executed its plan for a platform of extremities products built around its Compressyn and Tensyn technologies.