Medtronic faces federal probe over cardiac ablation therapy. Medtronic Inc. is facing a federal investigation over its marketing of cardiac ablation therapy. The revelation was made in a regulatory filing Wednesday.
Cardiac ablation therapy involves threading devices through tubes in the circulatory system to burn, freeze or otherwise kill diseased heart cells. The therapy is used to treat irregular heart beats.
According to Bloomberg News, Medtronic and other medical device makers have said they plan to enter the ablation market. As part of that effort, last year Medtronic acquired CryoCath Technologies Inc., of Kirkland, Quebec. In February, the company also announced its intention to acquire Ablation Frontiers Inc. of Carlsbad.
Product is approved to treat a spinal condition
The Department of Justice (DOJ) informed Medtronic of the cardiac ablation therapy probe via a letter Feb. 9. According to Bloomberg News, Medtronic has said it would comply with the probe.
In November, Medtronic revealed that the DOJ was investigating the marketing of one of its bone growth products, Infuse Bone Graft. The product is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.
Infuse Bone Graft is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.
Infuse Bone Graft and similar devices had caused serious problems
In July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries. In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft.
The Journal said that most of these complications cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites.
The Wall Street Journal also reported that doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light.
During a conference call with analysts last November, Medtronic chief executive Bill Hawkins said that the company was complying with the Justice Department’s request, but insisted that Medtronic was not promoting off-label use of Infuse. Hawkins said that if doctors were using the bone graft product in off-label procedures, it was because they had determined it “was the best therapy for their patients.”