FDA: No More Chances for Embattled Coagulation Monitoring System
Alere has announced that its point-of-care INRatio and INRatio2 PT/INR Monitoring System, which was used to measure coagulation levels in the ROCKET AF trial, will be withdrawn from the market following discussions with the US Food and Drug Administration (FDA).
The company initially issued a medical device correction in December 2014 to inform users that the system should not be used in patients with certain conditions because of the possibility of providing inaccurately low readings when compared with laboratory measurements.
ROCKET AF investigators have said that they did not find out about the issue until October 2015. Since then, they have reported multiple analyses—first in February and again last week—that they say show that use of the Alere system did not influence the conclusion of the trial—that rivaroxaban (Xarelto; Janssen Pharmaceuticals) is noninferior to warfarin for the prevention of stroke or systemic embolism in patients with nonvalvular A-fib.
Alere said it has investigated software fixes to address issues with the system, but this was not enough, apparently, to satisfy the FDA.
“Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market,” the company said in a press release.
“Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anticoagulation monitoring in the least disruptive manner possible,” the statement read.
Alere. Alere to initiate voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System. http://www.inr-care.com/content/dam/web/inratio/INRatio_Withdrawal_Press_Release_FINAL.pdf. Published on: July 11, 2016. Accessed on: July 11, 2016.