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societynews[dot] org
Severe control in one of his bone-growth products faced, Medtronic announced on Wednesday, that it was where to Yale to a complete review of the study data to monitor a $2.5 million grant, which examines the safety and efficacy of the product.
In June infusion called a medical journal charged that researchers sponsored by Medtronic had generated misleading studies about the product, their benefits that set too high and argued that there no risks.
The infusion is used primarily in spinal fusion, a procedure in which the vertebrae to back pain to reduce associated a biotechnological material. Industry analysts have speculated that decreased sales of infusion, as the magazine, the spine journal, its special issue on the product.
Experts said that Medtronic of action that first time, which would make a medical device maker on the underlying and detailed patient data from company-sponsored studies of independent experts was, so she could check and their own conclusions.
Generally companies release only summaries this information, a practice that can hamstring the ability of the experts to check it.
The infusion of about a quarter of the estimated 432,000 spinal mergers in the United States annually carried out was used.
When special edition appeared the spine journal, the company announced that it publishing assertions would respond to information by performing a review of all study infusion-related.
Under the plan announced Friday Yale is provided by Medtronic $2.5 million, use mount Panel of external experts, which will check the Commission then two scientifically recognised research institutes of the company data.
Dr. Harlan Krumholz, a cardiologist at Yale, which will oversee the efforts, said that Medtronic of decision was groundbreaking because it would allow independent researchers to assess the underlying data to support the safety and efficacy of the product.
"Published data is often important information missing", said Dr. O'Connor.
Dr. Eugene Carragee, editor of the spine journal, said he was pleased that Medtronic officials had decided to release the data.
The plan will be together on the study data for other researchers with the groups access, keeps the Yale.
Dr. Carragee, Professor at Stanford University, said that he remained concerned that little study data there for an important use of infusion, a type of spinal fusion, because a study of the application were already stopped when patients suffered complications.
Still, he added, Medtronic, the decision was "a big step in the right direction".
Infusion side effects include infection, bone loss, unwanted bone growth and male sterility.
A stronger version of infusion as step up, was rejected recently for approval by the food and drug due to concerns about possible Cancer risks.
Together with the current issue of the spine journal that leads Ministry of justice a criminal investigation of the Medtronic the marketing of the product and a Senate Committee performs also a request.
Medtronic has not been accused of any wrongdoing, and defended, researchers who have carried out research on infusion their results.
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