MedShape gets FDA clearance for Eclipse Soft Tissue Anchor

MedShape, Inc., the industry leader in innovative shape memory orthopedic devices, today announced the company received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Eclipse™ Soft Tissue Anchor, a new shape memory fixation device designed to attach a tendon, ligament or soft tissue to bone. Made out of MedShape's proprietary PEEK (polyether ether ketone) Altera^® material, the Eclipse Soft Tissue Anchor offers an innovative non-rotational insertion method that allows for improved fixation strength when compared to traditional screws and devices. The company will feature Eclipse at the Arthroscopy Association of North America (AANA) Annual Meeting April 25-27, 2013 in San Antonio.  

For surgeons looking for soft tissue reattachment solutions, the Eclipse anchor joins the MedShape family of soft tissue fixation devices, including the ExoShape^® Soft Tissue Fastener and Morphix^® Suture Anchor. Because it is compressed on one side, Eclipse allows 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 the bone. In addition, the Eclipse anchor offers a wider choice of sizes – it is available in diameters 4 through 9 mm, and 10 through 20 mm in length allowing for its use in a variety of soft tissue repair procedures in the shoulder, knee, hand/wrist, and foot/ankle. Like ExoShape, the Eclipse Soft Tissue anchor offers strong fixation, easy insertion and procedural versatility.

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

Loaded on a disposable gun for fast and intuitive implantation, the Eclipse Soft Tissue Anchor is a two-part sheath-and-bullet device made from MedShape's proprietary PEEK Altera material, a strong, yet highly deformable shape memory polymer (SMP). Using PEEK Altera's shape memory features, the Eclipse anchor can 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 PEEK Altera material is biocompatible, biostable, radiolucent and MRI safe.

"The eccentric shape and 2x sheath expansion provide enhanced soft tissue fixation for surgeons," said Griffis. "As a leader in shape memory devices, we are proud to respond to physician demand with this innovative product."