DePuy Spine Inc. is continuing to expand its line of products for degenerative disease with the launch of an anterior cervical plate system and a cervical allograft. Using the Uniplate 2, a single-screw midline fixation system, surgeons can customize the plate to fit a patient’s anatomy. It also allows surgeons to affix an implant using one screw per vertebral body, which reduces the need for retracting soft tissue (such as the esophagus) during implantation.
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.
A new laser machining technology can create very precise features in materials without thermal damage. Developed by Norman Noble Inc. (Highland Heights, OH), the ultrashort pulse laser machines materials such as bioabsorbable polymers and shape memory metals for stents, catheters, and other devices. “A laser system capable of cutting the tightest, most intricate geometry through virtually any material without generating any thermal damage to the material was once unimaginable to most design engineers,” says Chris Noble, vice president of Norman Noble. “Engineers had to design their products around removal of this thermal damage or use less than optimal materials.” Noble UltraLight allows engineers to machine materials with minimal variability and without the heat that occurs in traditional thermal laser manufacturing processes. It could also help companies shorten their time to market for implantable devices due to the speed of the process.
Researchers have found that drug-eluting stents could be more likely to break and cause blood clots than previously thought. According to a study in the Journal of American College of Cardiology, stents that were implanted for a longer period of time, longer in length, and overlapped each other were more prone to fracture. The study also cited that J&J’s Cypher stent had a higher risk of breaking than Boston Scientific’s Taxus stent.
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.
In an effort put in place by CEO Ray Elliott to resolve long-standing legal issues, Boston Scientific is paying $296 million to settle a U.S. Department of Justice investigation related to Guidant. The settlement deals with problems with Guidant’s heart devices before it was acquired by Boston Scientific. In a company statement, Elliott said the actions allow the company to put the issues in the past and “devote our full energies and resources to developing our innovative technologies.”
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.
Spinal device maker Facet Solutions Inc. (Hopkinton, MA) has raised $3.6 million and is in the process of raising an additional $4.7 million, according to President and CEO Geoff Pardo. The money will be used to fund an investigational device exemption study. The Journal of New England Technology reports that Pardo also suggested the $4.7 million that needs to be raised could involve an acquisition.
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.
Spinal device manufacturer K2M has entered the Japanese market with the launched of its MESA Spinal System. According to the company, the pedicle screw system is the lowest profile screw on the worldwide spine market. It uses Zero-Torque Technology, which applies no pressure to the spine when locking the screw. MESA also has instruments that give surgeons more versatility when operating. Yoshitaka Noguchi, senior director of Surgical Spine Inc., K2M’s Japanese spine business partner, stated that the technology is ideal for a smaller stature patient population.
An FDA review of Zimmer’s new titanium Dynesys implant for the spine found the device to be as good as the company’s Silhouette implant. However, the part of the 89-page document that is getting the most attention is the section that states, “The majority of patients treated in the study (in both treatment groups) were treated by financially interested investigators.” This is raising questions, according to the Associated Press, over whether Zimmer’s payments to doctors influenced trial results.
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.
Stryker has announced that chairman John W. Brown is retiring from his position of chairman of the board. Brown served as the company’s president and CEO from 1977 until 2003. He will replaced on January 1 by Stephen P. MacMillan, Stryker’s current president and CEO.
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
