Catheter Withdrawn From the Market Following Trial Findings
Published date : 16 February 2014
Article date : 16 February 2014
Endovascular Today reports that Medtronic has recalled its Amphirion Deep Balloon Dilation Catheter following the latest trial results for the device.
They say that in a notification sent to customers in early November, Medtronic stated that after 12 months of follow-up in the IN.PACT DEEP study, there was no difference found between the In.Pact Amphirion DEB treatment group and the standard balloon angioplasty control group in any of the study's three primary outcome measures.
The study also identified a potential safety signal with a trend toward an increased rate of major amputations in the DEB study arm.
