Studies: Medtronic's Infuse offers mild benefit, significant risk

Medtronic's Infuse is as effective as traditional bone grafts but carries more risks, according to independent reviews.--Courtesy of Medtronic

Medtronic's ($MDT) much-scrutinized Infuse spinal implant performs no better than traditional bone grafts and carries an increased risk of cancer, sterility and other side effects, according to two independent reviews.

Amid scorn from academics, surgeons and lawmakers, Medtronic agreed to submit Infuse data to the Yale University Open Data Access project, which examined the results of 17 trials on more than 2,000 patients in two separate reviews.

The researchers found that Infuse is just about equal to standard bone graft procedures. However, the ingredient used to spur bone growth in Infuse, called recombinant human bone morphogenetic protein 2, contributed to a spike in cancer risk, and investigators concluded that Infuse can still benefit a subset of patients but that physicians must clearly spell out the implant's risks before use.

Medtronic maintains that the data don't support a causal relationship between Infuse and cancer development, and the company is in talks with the FDA to find new applications for Infuse and other devices using the same protein. Infuse is still on the market, and Medtronic promises to keep reviewing registry data and keep tabs on the device's risks and benefits.

The company first came under fire in 2011, when Spine Journal revealed that Medtronic paid hundreds of millions in "consulting fees" to medical authors in exchange for underreporting adverse events and emphasizing benefits. In October, after a 16-month investigation, the Senate concluded that Medtronic manipulated data to boost sales of the implant, a charge the company refutes.

That said, commissioning the two independent reviews reflects the company's commitment to transparency, CEO Omar Ishrak said, and Medtronic's chief--who was still at GE Healthcare ($GE) for most of the Infuse saga--even tweeted the results.

"We recognize that our products and therapies must have the public and medical community's trust, so we will continue to create, test and explore new ways to make our clinical research available as part of our commitment to transparency and to providing information that informs the medical decisions that physicians make based on each patient's needs," Ishrak said in a statement.

- read the review results
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