Mar. 11--Medtronic's relationship with a group of doctors who potentially could use an important experimental heart valve from the company has attracted the attention of federal prosecutors.
The Fridley-based medical device manufacturer disclosed Wednesday that the U.S. Attorney for the District of Massachusetts is seeking documents about company's relationships with doctors at the Lahey Clinic in Massachusetts.
Word of the investigation follows a lawsuit over the summer in which a cardiologist claimed his former Lahey Clinic colleagues dismissed him in part because he resisted pressure to use more Medtronic heart devices.
Leaders of the medical group, the doctor claimed, wanted doctors to use more Medtronic products so their hospital could win a spot in an upcoming Medtronic study of an experimental device called CoreValve. The CoreValve product is part of a new generation of replacement devices for the aortic valve and is one of the most promising new areas of medical technology for heart device manufacturers.
In a regulatory filing Wednesday, Medtronic said it will comply with the terms of the civil investigative demand.
Medtronic hopes this year to launch a key trial of the CoreValve product in the U.S., where the company does not have approval to sell the product. In an interview last year, Dr. John Liddicoat, vice president and general manager of Medtronic's heart valve business, said the company's process to select potential clinical research sites "was
designed to be fair, objective and independent of commercial interests."
Medtronic spent $700 million to acquire California-based CoreValve Inc. last year.
Christopher Snowbeck can be reached at 651-228-5479.
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