FDA Clears Dallen’s Disposable Compressyn™ Staple Delivery System for Small Bone Fixation

We’ve covered Dallen Medical, Inc., before, with its range of sternal closure and ankle syndesmosis devices. Now the company has gained U.S. FDA 510(k) clearance for a disposable version of its Compressyn™ Staple Delivery System for small bone fixation.

Background

Dallen Medical’s patented Compressyn technology is the only rigid compression fixation technology that delivers continual, dynamic compression for small bone fixation.

The Compressyn system features a proprietary, stainless steel staple that springs into position upon delivery, providing active tension that creates strong, consistent compression. The Compressyn staples are more rigid than nitinol staples, minimizing the risk of splaying and allowing the company to claim improved patient outcomes, which may reduce treatment costs and length of hospital stay. The unique staple design also virtually eliminates distraction, which Dallen says has been an issue with competitive stainless steel offerings.

The company says it is responding to clinician demand with the introduction of its disposable Compressyn™ Staple Delivery System, claiming it represents a less expensive system that complements its reusable system and delivers the same high level of fixation.

 Company comments

“By adding a disposable system to our portfolio, we will be able to offer hospitals and surgery centers a more affordable option for small bone fixation without diminishing the system’s superior results, which responds to current efforts to improve the cost and quality dynamic in the healthcare system,” said Dallen Medical Chief Executive Officer David Mills. “The Compressyn Staple is designed to provide surgeons with the highest standard of rigid compression leading to optimal patient outcomes, enabling them to provide the best possible care to their patients.”

Source: Dallen Medical, Inc.

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