Yale Study: Little Benefit To Criticized Medtronic Product

Medtronic, however, claims that the new findings confirm those of earlier studies, and that the product is safe and effective but carries some risks that must be weighed by patients and physicians.
Yale Study: Little Benefit To Criticized Medtronic Product

An extensive review of a much-scrutinized Medtronic, Inc., “bone-growth” product found that the product provides little to no benefits over more typical treatments.

Fridley-based Medtronic, the world’s largest medical device company and one of Minnesota’s 10 largest public companies, received approval for its Infuse product from the U.S. Food and Drug Administration in 2002. The product is a bone-growth protein that is used in spinal fusion, and in recent years, reports have surfaced that question whether earlier studies had overstated benefits and understated the product’s risks.

In 2011, Medtronic, prompted in part by questions raised in a peer-reviewed medical journal, commissioned the Yale study. It provided a $2.5 million grant to help fund the independent review.

Medtronic gave Yale data from 17 completed clinical trials involving more than 2,000 patients, as well as post-market safety reports. Yale then assembled a panel of experts and commissioned researchers from Oregon Health & Sciences University and University of York in the United Kingdom to analyze the data.

The two resulting studies were recently published by the Annals of Internal Medicine and were the focus of a New York Times story.

The Oregon researchers stated that Infuse showed no evidence that it is more effective than iliac crest bone graft, a process through which graft material is taken from the patient’s hip, and there is “some evidence of an association with important harms.” In addition, researchers said they “found substantial evidence of reporting bias.”

The British team found that Infuse has higher fusion rates, but it “reduces pain by a clinically insignificant amount” and “increases early postsurgical pain.”

The New York Times, citing the most recently available data, reported that sales of Infuse, after reaching nearly $1 billion in annual revenue after its introduction, fell to $528 million. To read more about the Yale findings in the New York Times, click here.

Medtronic, meanwhile, said Monday that the findings of the Yale review are consistent with earlier studies, which were meant to show that the product is as effective as graft material harvested from a hip but lack the potential pain and complications associated with that procedure.

The Yale study results “add to a growing body of evidence” that Infuse is “a safe and effective treatment option for patients in approved indications for use,” Medtronic said in a statement.

The company said that “the findings reiterate, as with all therapies and surgical procedures, Infuse bone graft poses certain risks that must be evaluated carefully by patients and physicians before use.”

Medtronic Chairman and CEO Omar Ishrak said in a statement that the company “provided an unprecedented level of data access in order to test new approaches to data sharing of industry research.”

“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 added.