Navigation Links
MedShape Solutions Announces FDA 510(k) Clearance of Innovative Ankle Fusion Device
Date:8/9/2011

ATLANTA, Aug. 9, 2011 /PRNewswire/ -- MedShape Solutions, Inc., the industry leader in innovative shape memory orthopedic devices, today announced its new DynaNail™ 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."

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.

Media Contact:

Jenn Harrison
Carabiner Communications
678.313.3438


'/>"/>
SOURCE MedShape Solutions, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. MedShape Solutions, Inc. Announces Extension of ExoShape™ Product Line in Response to Surgeon Demand
2. MedShape Solutions, Inc. Named ATDC Graduate
3. MedShape Solutions, Inc. Announces Breakthrough in ACL Reconstruction
4. MedShape Solutions, Inc. Secures Investment From IQT to Support U.S. Intelligence Community
5. MedShape Solutions, Inc. Receives Industry Honors and Awards
6. MedShape Solutions, Inc. Appoints Jack Blair and Tom Hills to Board of Directors; Announces Additions to Management Team
7. SAIC Completes Acquisition of Vitalize Consulting Solutions, Inc.
8. Robertson Global Health Solutions Announces Progress Towards Commercial Venture with LifeSense
9. Varian Medical Systems to Offer CIVCO Medical Solutions Body Pro-Lok™ for SBRT
10. Cardiac Science Expands Device Connectivity Solutions
11. MedSolutions Introduces Spine Surgery Management Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ., ... developing innovative inhaled drugs, announced today that it was ... Investments reconstituted its comprehensive set of U.S. and ... "This is an important milestone for Pulmatrix," said Chief ... shareholder awareness of our progress in developing drugs for ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
(Date:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to a ... new, often overlooked aspect of head lice: the parasite’s ability to live away from a ... occurrence, but a necessary one in the event that lice have simply gotten out of ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... Rhinebeck, NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of ... of companies that call for a minimum wage raise to $12 an hour by 2020 ... wage. This will restore the lost value of the minimum wage, assure the wage floor ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... actively feeding the Frederick area economy by obtaining investment capital for emerging technology ... past 2½ years that have already resulted in more than a million dollars ...
Breaking Medicine News(10 mins):