Medtronic responds to scathing Star Tribune investigative report

Written by Laura Dyrda | April 12, 2016 | Print  | Email

The Star Tribune published a special report on Medtronic's Infuse studies on April 10, examining the FDA studies and lawsuits against the company, but ending on CEO Omar Ishrak's plans to expand the marketshare for biografts using Infuse.

On April 11, Medtronic responded.

 

Medtronic claims the article made false insinuations and lacked "important information" about the retrospective chart review and the company's actions. The editorial also mentions Medtronic gave the Star Tribune information about the retrospective chart review that didn't appear in the article.

 

The company acknowledged the RCR was discontinued and not properly archived and reported to the FDA; the company has taken steps to improve policies for clinical trials and reporting since then.

 

Medtronic also mentioned efforts to assess and report information in 2013 when the RCR data was identified. The company also claims the paper mischaracterized adverse event data use in the Yale systematic review, clarifying the Yale meta-analysis only included "adverse event data collected during clinical trials."

 

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