Payments cited in FDA report ahead of Zimmer-device talks

Washington A Food and Drug Administration panel will meet today to discuss a Wabash, Ind.-based company’s implant that appears to be effective in treating spinal problems.

But questions were raised in an FDA report in advance of today’s hearing about whether Zimmer Holdings’ payments to doctors influenced the device’s trial data.

Zimmer has asked the FDA to approve its titanium Dynesys implant to restabilize the spine.

Agency reviewers said in the report, issued Monday, that a Zimmer study of the device met its goal, showing results at least as good as those of the company’s older Silhouette implant. Patients implanted with Dynesys showed a 52 percent treatment success rate, compared with 40 percent for Silhouette.

Most patients in the trial were treated by surgeons who had received consulting payments. More than half of the patients were treated at medical centers that reported more than $100,000 in payments from the company, according to the FDA’s review. (AP)

Closure Systems International to expand presence in India

Indianapolis Northwestside-based Closure Systems International will open a plant to make plastic beverage closures near Bangalore in southern India. The plant, to begin production early next year, will be the company’s second to serve the Indian market. Lance Mitchell, Closure’s president, said in a statement Tuesday that major global and regional beverage customers are significantly increasing investment in India because of higher demand. Closure has 30 production plants worldwide. (Star report)

Wabash National unit will sell Illinois plant in consolidation

Lafayette Semitrailer maker Wabash National Corp. announced Tuesday that its subsidiary, Transcraft Corp., agreed to sell its Anna, Ill., production facility and consolidate its operations into its Cadiz, Ky., plant by July. Cadiz also will become Transcraft’s headquarters.

Transcraft, which makes bodies, flatbeds and other truck features, plans to sell the Illinois facility to a lumberyard and home center business.

Dick Giromini, Wabash National president and chief executive officer, said in a statement: “This will complete the consolidation process of the company’s platform business, which began in October 2007 with the closure of the Mount Sterling, Ky., plant. Similar to our Lafayette Transformation Project completed earlier this year, this consolidation initiative continues the optimization of our production facilities and overhead cost structure that we have been focused on throughout the current economic climate.” (Star report)