Trauma

The FDA has granted 510(k) clearance to a muscle and joint rehabilitation medical device that tricks the brain into re-establishing communication with muscles affected by brain or spinal cord damage.

Medical Device Firm iTraumaCareTM Receives FDA 510(k) Clearance for iTClampTM Hemorrhage Control System

The FDA has approved an IDE for InVivo’s biopolymer scaffold, making it the first such treatment to dip its toe in the America patient population. The new study is expected to deliver a Humanitarian Device Exemption, giving it access to market sooner than a PMA.

If you’re of a certain vintage, if your bones are osteoporotic and you suffer a hip fracture, you are at risk of suffering one on the other side. In a piece of potentially smart-thinking a Bordeaux company has a minimally invasive device that might protect you against that eventuality.

Magnesium has been creeping into our consciousness as a potential new material from which to manufacture stents. It’s metallic, but also absorbable so may bring the best of both worlds. Now trauma and biomaterials company aap Implantate has entered a JV with a Chinese magnesium specialists to open the door in trauma devices.

Steven Ek has been named ArthroSurface’s President and Chief Executive Officer, effective November 20, 2012. Mr. Ek is one of the original founders in Arthrosurface and a Director since inception.

Fixes 4 Kids, Inc. has chosen the forthcoming AAOS meeting at which to launch its E-Fix Supracondylar Humerus Fracture Reduction and Pinning System (E-Fix) and E-Thotic perioperative orthosis (E-Thotic). The company says this is the first system designed to treat supracondylar (distal humerus) fractures in children.

Even without the revenue following the acquisition of DePuy’s trauma business, Biomet’s SET products showed impressive double digit growth. Joints nudged up too, but it’s SET that has underpinned the company’s positive sales momentum.

Collaborative research performed between the Universities of Edinburgh and Southampton has resulted in a material that combines a plastic scaffold with the potential for stem cell regeneration of bone. It’s hoped the development may result in an expanded ability to repair bone in the most traumatic fracture cases involving bone loss.

Planmed Verity® is designed to find subtle extremity fractures at the first visit to the clinic – fractures that have been the most commonly missed using only 2D radiographs. Now the device is available for sale in USA too.

Zimmer Holdings, Inc. has introduced the Zimmer V2F Anterior Fixation System, a new implant system for the treatment of thoracolumbar burst fractures, tumors, disc degeneration and other pathologies of the anterior spine. The system represents Zimmer’s first lateral plate system for the spinal trauma segment.

We’re loving the number of really clever devices coming before us at the moment. This really smart device for performing distal radius fracture fixation in a minimally invasive manner is a case in point.

Biomet has released its financial results for the most recent quarter, showing a net sales increase of 9% compared with a year ago. Income and earnings showed similarly healthy increases, although one-off costs translated into a significantly bigger net loss than in the equivalent period.

The UK’s National Institute for Health and Clinical Excellence (NICE) has published new guidance supporting the use of the Exogen device to heal long bone fractures with non-union at 9 months, but uncertainties in the evidence mean the jury is still out on 3 month old non-unions.

German trauma device company aap Implantate has announced that the first six systems of the Loqteq® Trauma Plating family of products has gained FDA 510(k) clearance. The company says it will commence commercialisation early in the new year.

Smith & Nephew has chosen to announce the launch of its Trigen™ Low-Profile Screw at this week’s Orthopaedic Trauma Association meeting in Minneapolis. In a press release it says Trigen is the only truly “captured” head, low-profile screw on the market.