The Vertigraft VG2, a cervical allograft, is the first allograft that can be stored at room temperature when fully hydrated. It uses Preservon, a glycerol-based preservation technology developed by LifeNet Health, that eliminates the need to freeze or freeze-dry the product.

Both products were introduced at the North American Spine Society’s annual meeting in San Francisco. In the past three years, DePuy Spine has introduced 30 products that address aging, degenerative disease, deformity, and spinal disorders. In addition to its product launches, the company opened the DePuy Institute LLC at its Raynham, MA campus in August. The center provides education, training, and research in nonsurgical and surgical treatments related to orthopedics, spinal care, sports medicine, soft tissue repair, trauma, and neurosciences.

The researchers found breaks in 51 of the 177 stents (29%) that they studied, which they stated is much higher than clinically reported. Nearly two-thirds of those fractured had signs of scar tissue or blood clots. In addition, most breaks were in the middle of the device. This information could help doctors know where to look if they suspect a fracture.

The Boston Globe is also reporting Wall Street rumors that the Guidant unit could be combined with Boston Scientific’s cardiovascular business in Minneapolis. Analyst Larry Biegelsen speculates that a significant company reorganization could be underway by the end of this year.

In an announcement made this morning Facet Solutions has acquired Archus Orthopedics. The deals gives the company a stronger IP hold, with 36 patents and nearly 200 patent applications.

Facet Solution’s core product is the Acadia joint reconstruction device, which is currently in a clinical trial. It matches the size and shape of the facet joint and uses conventional pedicle screw fixation to preserve motion and stability.

The majority of trial patients were treated at sites that received payments from Zimmer, and slightly more than half were treated at centers that received compensation greater than $100,000, according to the FDA document.

UPDATE: In a meeting held on Wednesday, November 4, an FDA panel rejected the spinal implant in a 5-1 vote. Among the concerns of the panel were device wear and a lack of clarity regarding how patients would benefit from the device.

This announcement follows the recent indictment of four employees at Stryker Biotech on charges of wire fraud and conspiracy. According to the Kalamazoo Gazette, the indictment alleges that the employees engaged in a “fraudulent marketing scheme” involving devices used to stimulate bone growth in long bones and the spine.

The Kalamazoo Gazette states that if Stryker does not resolve these charges, the company could be excluded from federal and state healthcare programs.

-From DeviceTalk

Despite the anticipated growth, analysts still see pricing pressures as an obstacle. Economic conditions are pushing hospitals to pressure surgeons to choose products that are less expensive. For a company like Zimmer, which manufactures premium-priced implants, this could be a problem. In a recent Canaccord report, analysts suggest that Zimmer has been lowering its pricing in order to hold market share. If this is the case, they speculate that such actions could result in a price war that would inhibit growth and innovation.