BD has responded to warnings from the FDA surrounding risks from drug-coated devices by trying to reassure customers and shareholders.
FDA approval
The company says it stands by “the robustness of its pre-clinical and clinical data” surrounding its Lutonix drug-coated balloon (DCB).
In a statement, BD said: “Over the past several months, BD has completed an extensive, comprehensive review of all available Lutonix DCB clinical data and these analyses continue to confirm the safety and efficacy of our products.
“The FDA acknowledged that the cause for the increased risk of mortality is unknown, that there is a limited amount of long-term data (which creates variability in estimating mortality risk) and that the data was not designed to be pooled. Yet, the FDA determined to issue the letter primarily, it would appear, on a limited review of data from less than 1,000 patients combined from three studies with five-year data (completed by BD, Medtronic and Cook Medical).
“BD's LEVANT 2 study enrolled 1,189 patients for the FDA panel's safety evaluation; this intent-to-treat (ITT) population was re-evaluated at five years and we do not see a signal of increased long-term mortality in this large patient cohort. While subset analysis of the randomised portion (476 patients) of the Levant 2 study did cross the line to significance at five years, the broader data set confirms the safety of this product and is larger than the pooled dataset referenced in the FDA letter.
“BD has reviewed the patient level data from randomised portion of the LEVANT 2 study extensively. There are several known confounding factors for mortality over the five-year period. Said simply, there are causes of mortality for some participants that could not reasonably be attributed to paclitaxel (e.g., pre-existing cancer). When excluding those individual deaths, the subset analysis of the randomised portion no longer crosses the line to significance at five years. We have also engaged an independent third-party contract research organisation (CRO) to repeat our analyses and perform its own.”
The company added it is working with the FDA and VIVA Physicians Group to support an independent patient-level meta-analysis that is expected to be completed for mid-June 2019.