On Thursday the FDA Circulatory System Devices Advisory Panel issued a unanimously favorable recommendation on C.R. Bard s Lutonix drug-coated balloon over-the-wire percutaneous transluminal angioplasty catheter. While there are still some areas to monitor, we believe that the product will ultimately receive approval by year-end.
There was some concern about a positive panel decision when the panel materials were released on Tuesday (panel materials released by the FDA tend to be negatively-skewed), and more scrutiny occurred this morning when the agency presented its statistical analysis showing Per Protocol data missed both primary efficacy and safety endpoints.
Additionally, there was an odd split in terms of international and domestic results; superior efficacy was not demonstrated in patients in the U.S., while the primary safety endpoint was not met in international regions. On top of this, the agency focused on the fact that the data suggested that there is lack of statistical evidence (unclear whether or not there is clinical evidence) that the device is effective in females in the U.S and whether the pre-dilation prior to deploying the DCB was the source of the vessel patency in the control arm.
Following a rather rocky morning session, all nine panel members voted that the device is safe and effective, and that its benefits outweigh the risks. The majority of members did hope for additional safety and efficacy with the device, and we believe a post-market approval study will likely be required. Further, the label for the device will be an area to monitor (we doubt there will be a limit to deploying the device in females domestically); however, we do believe the product will ultimately be approved (simply put, these panels always appear negative and include heavy scrutiny, but the fact that it was a unanimous recommendation makes us believe that the agency will clear the device).