Stanford study: Medtronic’s Infuse poses risk of male sterility

Medtronic Spine, which is already a little bent out of shape, took another blow last week.

The New York Times reported that a Stanford University surgeon has released a study that shows one of the Fridley company’s top-selling spinal products — Infuse — can pose a risk of male sterility. Infuse is a bone growth product used in spinal fusion procedures.

The article notes that the study conducted by Stanford surgeon Dr. Eugene J. Carragee, “found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received abone graft, another material that is used to fuse spinal vertebrae.”

That runs contrary to Medtronic-sponsored studies. Those studies published by some researchers compensated by Medtronic found that while sterility-related complications were a side effect of Infuse, as noted in its label, it was related to surgical technique and not the product itself.

On Wednesday, a Medtronic spokesman reiterated that claim and sought to question the results of the Stanford study.

“With an issue like retrograde ejaculation, in which there is literature showing it to be a procedural adverse effect, it is important to look at data from randomized, FDA-regulated trials in which there are multiple surgeons participating, instead of looking at data from a nonrandomized data set, such as a single surgeon’s own patients, as was the case at the Stanford study,” said Brian Henry, the spokesman, in an email.

Henry added that Medtronic did another study following market clearance of the product where the rates of retrograde ejaculation “were nearly identical to those who received Infuse and those who did not.”

Still, the article raised the question of whether doctors who receive industry compensation can produce research that is truly independent and do not take into account the benefit of the corporate sponsor. Two surgeons who took part in the original Infuse trial included in the PMA application to the U.S. Food and Drug Administration defended their findings.

And the Medtronic spokesman reiterated that the company submitted each surgeon’s financial interests based on FDA regulations.

Medtronic’s spine segment has not been performing well recently. The multibillion-dollar Kyphon acquisition has not gone as the company hoped and Medtronic said May 24 that revenue declined 9 percent in the company’s recent quarter. Overall, spinal fourth-quarter revenue of $875 million decreased 1 percent. Infuse sales were also down. JP Morgan analyst Michael Weinstein said he was very surprised by how much bulk orders fell in the company’s spine division and that in the United States, performance was far short of what Wall Street was expecting.

In response, Medtronic CFO Gary Ellis could only say that “we’re making some progress with our new products in that marketplace, but it’s just taking time to get those all launched and out there in the market and really have the impact we would expect.”

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