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.”
More articles on orthopedic devices:
Stryker Spine acquires SafeWire, builds on MIS presence—5 things to know
K2M gaining foothold on complex spinal deformity market: 4 insights
DJO CFO, executive VP Susan Crawford to retire
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
