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FDA approves Medtronic’s next-generation Kyphon back device

Medtronic Inc. says the Food and Drug Administration has approved its next-generation Kyphon technology to treat vertebral compression fractures in the back.

During the procedure, doctors insert a balloon into the damaged bone. Once inflated, the balloon creates a void. Doctors then fill the space with bone cement, stabilizing the bone and reducing pain.

Medtronic’s Kyphon Xpander II is designed to allow doctors to better predetermine the balloon’s inflation pattern and to exert greater lifting force.

 “Xpander II joins a host of innovative new products in what is the largest launch in our division’s history,” Alex DiNello, vice president and general manager of the Kyphon Products Division, said in a statement. “Xpander II is the flagship product in our division’s revitalized product platform.”

Medtronic purchased Kyphon Inc. for $4.2 billion in 2007 but has struggled to integrate the company. As a result, the financial performance of the entire spine unit has suffered. Medtronic’s spine revenue during the first quarter fell 5 percent to $829 million.

The company expects to launch Kyphon Xpander II in America next month and international markets in 2011.

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