Medtronic Inc. products used to help bone growth in spinal-fusion procedures are facing growing scrutiny by both the FDA and Department of Justice.
The New York Times reported that the Justice Department is continuing an inquiry into the marketing for Infuse, which has been used to help treat wounded soldiers.
The FDA, meanwhile, turned down a new product, called Amplify, which uses similar technology. The FDA sent the company a “non-approvable” letter in March, which addresses concerns about the product.
The products are designed and distributed in Memphis, where Medtronic’s spinal and biologics business units are based. The company employs 1,500 people in Memphis.
In response to the FDA letter in March, Medtronic spokesperson Marybeth Thorsgaard said the company would continue an “active dialogue” with the FDA to bring Amplify to market.
Medtronic’s biologics sales reached $235 million in third quarter and $658 million through the first three quarters of the fiscal year. Those figures are higher than a year ago, when third quarter sales were $212 million and first, second and third quarter sales combined were $651 million.
Infuse makes up a vast majority of Medtronic’s biologics sales, according to Larry Biegelsen, an analyst with Wells Fargo Securities interviewed by NYT. He projected biologics sales would reach $897 million in the full fiscal year, compared to $868 million in the previous year, according to the newspaper.