MedShape Solutions Announces FDA 510(k) Clearance of Innovative Ankle Fusion Device
DynaNail Intramedullary Fusion Nail actively adapts to changes in the surrounding bone to
increase potential for successful joint fusion
ATLANTA (August 9, 2011) - MedShape Solutions, Inc., the industry leader in innovative shape memory orthopedic devices, today announced its new DynaNailTM Intramedullary Ankle Fusion Nail. Ankle fusion is performed to relieve pain in patients with severely degenerative ankle joints, to correct joint deformities or to revise failed total ankle replacements. The DynaNail's unique, patented design utilizes shape memory alloy technology to actively adapt to changes, such as local bone resorption, in the arthrodesis (fusion) site. By adapting to such changes, the DynaNail may better maintain close apposition of the bones and compression across the fusion zone during the healing process. Bones in contact with each other and under compressive load heal together faster than bones held apart.
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."