MedShape Releases ExoShape Tissue Fastener (Elizabeth Hofheinz @ OTW)
MedShape, Inc. has announced the full U.S. commercial release of the ExoShape Soft Tissue Fastener, a two-part PEEK Altera interference fixation device meant to simplify and improve soft tissue graft fixation during anterior cruciate ligament (ACL) reconstructive surgery. MedShape has shipped the first full launch instrumentation sets to its sales agents to support surgeon demand for the product following a successful soft launch during 2011.
“We undertook a controlled market introduction of the ExoShape product to key sports medicine surgeons last year and received a tremendous amount of valuable feedback. We used this detailed information to further enhance the instrumentation and refine the surgical technique,” said Kurt Jacobus, president and CEO of MedShape, Inc., in the January 17, 2012 news release. “We firmly believe that the ExoShape Soft Tissue Fastener will fulfill our promise to surgeons to deliver a unique, effective and easy-to-use tibial soft tissue fixation system.”
Jacobus told OTW,
We received a lot of extremely positive feedback regarding the performance of the ExoShape Soft Tissue Fastener during the soft launch period. All the suggestions from surgeons centered around modifications to the surgical instrumentation. Many surgeons asked for a system that required only two hands to hold the instruments, insert the device and simultaneously apply tension to the graft construct. We designed a simple graft bar that integrates easily with the other instruments to eliminate the need for an extra pair of hands. We also made ergonomic changes to the ExoShape Gun in order to make it as intuitive to use as possible. Most of the changes were small improvements that make a huge difference to procedural simplicity in the operating room.
As indicated by the company, design improvements include: The ExoShape Soft Tissue Fastener’s deployment gun facilitates full expansion of the PEEK Altera shape memory sheath without rotational motion, thereby preserving the surgeon’s desired graft bundle orientation. The ExoShape Gun and ExoShape Cartridge utilize a closed force loop for sheath expansion, eliminating the need for forward force on the sheath. This allows the surgeon to confirm desired graft tension prior to final device deployment. Graft tension remains unchanged during ExoShape deployment. The use of MedShape’s proprietary PEEK Altera shape memory polymer enables the sheath to be pre-compressed to a low profile for easy insertion and then fully expanded for effective graft-to-tunnel compression and secure graft fixation. The ExoShape Gun provides a convenient mechanical advantage for easy deployment of the ExoShape PEEK Altera shape memory Sheath.