The US Food and Drug Administration (FDA) has granted 510(k) clearance to MedShape‘s new shape memory fixation device.
The Eclipse soft tissue anchor device, which forms part of the company’s soft tissue fixation devices, including the ExoShape Soft Tissue Fastener and Morphix Suture Anchor, is made from a proprietary polyether ether ketone (PEEK) Altera material.
Loaded on a disposable gun for the implantation of tendon, ligament or soft tissue to bone, the two-part sheath-and-bullet device is compressed on one side and with its non-tapered shape provides more soft tissue compression across the bone.
The platform, which incorporates an open tip in the sheath for a suture to be fed through the implant, is also available in diametres of four through nine millimetres, and ten through 20mm in length for use in various soft tissue repair procedures in the shoulder, knee, hand / wrist and foot / ankle.
Eclipse lead development engineer Jack Griffis said the Eclipse soft tissue anchor provides a non-rotational insertion and fixation method that maintains graft bundle orientation and tension with simplified delivery.
"Because it is compatible with both arthroscopic or mini-open procedures, it allows surgeons the freedom to select their own preferred soft tissue management strategy," Griffis added.
"The eccentric shape and 2x sheath expansion provide enhanced soft tissue fixation for surgeons. As a leader in shape memory devices, we are proud to respond to physician demand with this innovative product."
