FDA clears new soft tissue anchor device

MedShape Inc. received FDA 510(k) clearance for its Eclipse Soft Tissue Anchor, a shape memory fixation device designed to attach a tendon, ligament or soft tissue to bone.

According to a press release, the Eclipse Soft Tissue Anchor offers a non-rotational insertion method that allows for improved fixation strength compared to traditional screws and devices. It is made from MedShape’s proprietary Peek Altera material, allowing the anchor to be compressed into a compact temporary form to facilitate easy insertion into a target surgical site and later expanded into its final functional geometry for fixation without loss of mechanical integrity.

The Eclipse is compressed on one side, allowing more space for surgeons to accommodate a tendon alongside the implant. It also incorporates an open tip in the sheath for a suture to be fed through the implant, and its non-tapered shape provides more soft tissue compression across bone. With strong fixation, easy insertion and procedural versatility, the Eclipse Soft Tissue Anchor is available in diameters 4-mm through 9-mm and 10-mm through 20-mm in length for use in a variety of soft tissue repair procedures in the shoulder, knee, hand/wrist and foot/ankle.

“The Eclipse Soft Tissue Anchor provides a non-rotational insertion and fixation method that maintains graft bundle orientation and tension with simplified delivery,” Jack Griffis, lead development engineer for Eclipse, stated. “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.”