Orthopaedics

Bloomberg has reported on the pre-trial testimony of Paul Voorhorst, a DePuy biostatistician, as a preamble to proceedings in the case of Loren Kransky vs J&J (DePuy), for which the jury sits tomorrow (Friday 25th January). In it, previously unseen documents suggest that the company’s own estimates of failure rate for some of its metal-on-metal hip prostheses are now as high as 37%, significantly higher than the 12 or 13% cited in the original recall notices.

Zimmer has received FDA 510(k) clearance to market iASSIST™ Knee, the Personalized Guidance System™ for knee replacement procedures. Zimmer says its device provides simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons during joint replacement procedures, eliminating the need for bulky capital equipment.

Some patients in some situations still benefit from metal-on-metal hips. The FDA has now issued a guidance document, laying out its considered view on the use of these devices, including ongoing assessment of patients already implanted with them.

In a Monday morning mood to challenge everything that gets touted as evidence, we have a bit of a nibble at research claims that articular cartilage degeneration can be reversed with a hydrogel infill.

In what is another sign of consolidation in the medical device industry, orthopaedic giant Zimmer Inc is reportedly closing its Austin, Texas operation.

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.

A poor Q4 for Orthofix in its international markets, has meant that annual sales of approximately $462M are well below the projection of $472-475M made as recently as one quarter ago. U.S. business looks resilient however.

Early stage orthopedic device company, Soft Tissue Regeneration, has developed a breakthrough tissue engineering platform used to regenerate ligaments and tendons. The company has announced that it has received FDA clearance to market its STR GRAFT, a biodegradable scaffold used for soft tissue augmentation and rotator cuff repair.

Pioneer Surgical Technology, Inc., a leader in innovative medical devices, has created an office in Konstanz, Germany, demonstrating its commitment to grow in what it calls a key market.

Settlement amounts have been approved for the DePuy Hip Implant litigants in Australia, fueling hopes that U.S. settlements are nearing. The Australian National Joint Replacement Registry, which began reporting problems to DePuy in 2007, led the fight to have the devices removed from the market.

Misonix says it is acting in a manner consistent with its business strategy by electing to sell its products under its own label via its own proprietary sales organization. With its now defunct distribution agreement less than 2 years old, Aesculap might be a little aggrieved.

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.

Covidien must be hoping surgeons will see the benefit of simplicity in its new meniscal repair device which has the retro feel of the twin needle gizmos we first saw twenty years ago.

First NiTiNOL-based intramedullary nail, DynaNail is used successfully in ankle arthrodesis surgery in Chicago

By integrating BioMimetics’ breakthrough biologics platform and pipeline into its extremities business, Wright Medical Group will hope to dominate the market, especially if the company’s Augment® bone graft gets the FDA PMA nod.