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MedShape Announces First Clinical Outcomes with FastForward Bunion Correction System
Bone-Sparing Procedure Features Novel 3-D Printed Plate

 

ATLANTA (April 25, 2016) - MedShape Inc., the industry leader in orthopedic devices using advanced material technologies, today reported on the first wave of clinical outcomes with the FastForward Bunion Correction System. Under a limited market release since 2015, FastForward has been implanted in over 100 hallux valgus (bunion) correction surgeries. The FastForward system uses a novel bone-sparing approach to address bunion deformities and is comprised of an innovative Bone Tether Plate, QuikCord suture tape, and PEEK interference screws. Featuring MedShape's latest technology platform, 3-D printed titanium alloy (Ti-6AL-4V), the Bone Tether Plate is designed to match the native second metatarsal anatomy and shield the bone from large stresses.

Almost two-thirds of Americans will develop a bunion in their lifetime with many requiring surgical intervention to relieve the pain. Traditional surgical approaches involve either cutting and realigning the first metatarsal (osteotomy) or fusing the first metatarsal-cuneiform joint (Lapidus). These procedures can result in a painful recovery and require the patient to remain non-weightbearing for several weeks to allow for bone healing. Consequently, patients forgo or delay having surgery in order to avoid the recovery process. The FastForward system reduces the first-second intermetatarsal (IM) angle and controls first ray hypermobility via a patented tethering approach, thereby providing anatomic correction while still preserving and protecting the bone anatomy. Because there is no osteotomy or fusion performed, patients who receive the FastForward procedure are able to walk immediately in a surgical boot. With the anatomy-matching design of the Bone Tether Plate and by not requiring any drill holes through the second metatarsal, FastForward also reduces unwanted stress concentrations associated with other suture button tethering systems.

Drs. Dawn Buratti and Vladimir Zeetser, from Tarzana, Calif., were two of the first surgeons to use the FastForward and have found FastForward to be effective in treating a variety of bunion deformities.

"One of our first FastForward cases was a symptomatic juvenile hallux valgus deformity with significant first ray hypermobility," said Dr. Buratti. "Traditionally, surgery would have been deferred until age 17 or 18, at which time the deformity would have likely progressed from moderate to severe. However because the apparatus used in the FastForward procedure is placed mid-shaft, it does not interfere with the growth plates. We were able to provide a surgical option to reduce the IM angle and reduce first ray hypermobility via an intermetatarsal pseudoligament. Post-operative recovery was fully weightbearing in a cam walker boot for 6 weeks. Now 16 months post-surgery, the patient has maintained correction and participates in normal activities, including cheerleading. The procedure provided a nice alternative to what otherwise would have necessitated a lapidus fusion or a base wedge osteotomy."

Dr. Zeetser further adds, "I have been impressed with the amount of correction I can obtain with the FastForward system. In instances where patients would previously have only been suitable candidates for a Lapidus fusion with prolonged cast immobilization, I have been able to perform the FastForward procedure and have my patients to immediately weightbearing in a surgical boot following surgery. From a surgeon's perspective, this procedure avoids some of the problems associated with Lapidus fusion such as shortening of the first metatarsal, transfer stress to lesser metatarsals and potential delayed or non-unions. This has dramatically reduced the number of osteotomies I am performing. In fact, the FastForward procedure has become my primary alternative to traditional bunion surgeries."

Dr. Jason Lin from Good Samaritan Hospital in Corvallis, Oreg., has observed similar success with using the FastForward system.

"The FastForward bunionectomy procedure has been a game changer for my practice. It has become my preferred technique for correction of most hallux valgus deformities," commented Dr. Lin. "The FastForward is a reproducible system with a relatively quick learning curve and excellent clinical results. Compared to other techniques that require osteotomies or fusions, my patients have reported faster resolution of post-operative pain and swelling. In addition, I feel more comfortable allowing patients to transition back into normal footwear without fear of non-union.  Radiographically, I have been impressed with the more anatomic appearance of the first metatarsal (vs. non-anatomic osteotomies), which allows for more reliable measurements of IM and hallux valgus angles, and with the ability to restore sesamoid position."

With over a year of clinical data collected, MedShape is now preparing for a full launch of the product. The FastForward Bunion Correction System joins MedShape's growing foot and ankle product portfolio which includes the DynaNail® TTC Fusion System and Eclipse Soft Tissue Anchor. For more information on any of MedShape's products visit www.medshape.com or contact the company at 877-343-7016.

About MedShape, Inc.:

MedShape Inc. is a privately held medical device company working to develop and commercialize a portfolio of surgical solutions that use its patented material technologies to address the increasing demand for improved joint fusion, sports medicine, and musculoskeletal trauma products. For more information, visit: http://www.medshape.com. ExoShape and PEEK Altera are registered trademarks of MedShape Inc. All other trademarks and trade names are the property of their respective holders.

DynaNail is a registered trademark and QuikCord is a trademark of MedShape, Inc. FastForward is a licensed trademark of MedShape, Inc.

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Kathryn Smith, Ph.D.
MedShape, Inc.
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