How does the device hold the tendon so securely?
The device has a unique way of gathering the collagen fibers of the flexor tendon and wedging them between the coil and core portion of the anchor device. This harnesses the intrinsic strength of the flexor tendon. When force is applied to the tendon the fibers are pulled into the distal portion of the anchor allowing for a very strong hold reducing the chance of “rake out” as is often seen in the standard suture repair. The anchors on each end of the tendon are held together by a 2-0 stainless steel suture which has been cycled to over 26 million cycles and has a tensile strength of 90 Newtons (approximately 21lbs). As of May, 2007, a redesigned anchor, the Xtra, which replaced the original, increased the hold on the tendon by 50%.
Related Questions
- I use a mobile device for connecting to the internet for drug information but it does not hold any patient sensitive information. Do I need to take the actions outlined in Requirement 318?
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