MedShape, Inc. has announced the receipt of 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. The product is made of MedShape’s proprietary PEEK (polyether ether ketone) Altera material, and offers a non-rotational insertion method that allows for improved fixation strength.
MedShape: FDA Nod for Eclipse
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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, in the April 18, 2013 news release. “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.”
The Eclipse is loaded on a disposable gun, and 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). As indicated by the company, 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.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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