MedShape Solutions, Inc. Announces FDA 510(k) Clearance of Innovative Ankle Fusion Device
Published: Aug 09, 2011
The DynaNail device, intended for tibiotalocalcaneal arthrodesis procedures, incorporates an innovative shape memory internal element that is simply stretched during the insertion procedure. Once the nail is fixed in place with screws, the shape memory alloy element maintains the target fusion bones in close apposition and under sustained compression for longer time periods than static, non-adaptive intramedullary devices. Surgeons implant the DynaNail using a surgical technique similar to that of traditional ankle fusion nails, thereby dramatically reducing the learning curve required for the new technology.
Surgeons also commonly use external fixation devices, consisting of bulky frames connecting the patient's lower leg to the foot, to achieve ankle fusion. The surgeon may adjust such external fixators during the bone-healing period to maintain bony apposition and compression, but these devices often demonstrate poor patient compliance and ongoing management issues.
The DynaNail's co-inventor, Dr. Doug Pacaccio of Advanced Foot and Ankle Surgeons in Yorkville, Ill., stated, "The DynaNail combines the patient compliance and easier post-operative management benefits of internal fixation devices with an external fixator's ability to keep the bones in the correct healing position and under compression for a longer period of time. The DynaNail offers a dynamic, more patient friendly alternative to bulky external frames that can present significant patient care issues in the post-operative period.
"The DynaNail design offers surgeons the ability to minimize some traditional device performance issues that can negatively impact the ability to achieve a solid fusion," he added. "Patients often require an ankle fusion as a potential salvage procedure prior to surgical amputation. I am delighted that MedShape can offer this exciting new technology to improve the prognosis of patients who might otherwise be facing this daunting prospect."
Kurt Jacobus, president and CEO of MedShape Solutions, said, "This has been a very positive summer for MedShape. We recently received notification of a patent allowance that relates to our core technology for dynamic, self-adapting fracture fixation devices. We also received 510(k) market clearance from the U.S. Food and Drug Administration on the first product derived from that unique technology. We continue to push forward and execute our commercialization plan based on researching, developing and marketing scientifically proven products that make a real difference in patients' lives."
About MedShape Solutions
MedShape Solutions, Inc. is a privately held medical device company focused on developing orthopedic devices from proprietary shape memory technology. MedShape has fully commercialized two devices manufactured from PEEK Altera® shape memory biomedical polymer. The MORPHIX® Suture Anchor is used to attach sutures to bone during soft tissue repair procedures. The EXOSHAPE® Soft Tissue Fastener is used to securely fixate soft tissue grafts on the tibial side during anterior cruciate ligament (ACL) reconstruction procedures.
For more information about how MedShape is Shaping the Future of Orthopedics, visit www.medshape.com.
ExoShape, PEEK Altera, MORPHIX, and Shaping the Future of Orthopedics are trademarks of MedShape Solutions, Inc.
SOURCE MedShape Solutions, Inc.