Report on first clinical results of drug-eluting balloon technology below the knee from LINC


Drug-eluting balloons show better rates of reducing restenosis than standard PTA


Invatec, a comprehensive innovator of interventional products, welcomed the first clinical results of the drug-eluting Balloon (DEB), IN.PACT Amphirion, for complex critical limb ischaemia (CLI) below the knee.


Andrej Schmidt, leading investigator from the Park Hospital Leipzig, reported during the LINC congress, preliminary results indicate a dramatic reduction in restenosis rate by application of the drug-eluting balloon. “In our experience, 69% of critical limb ischaemia patients with long lesions show restenosis after three months. The drug-eluting balloon was able to bring this number down to 31%. Considering the mean lesion lengths of 17cm and 58% rate of total occlusions prior to intervention, these results have the potential to change the way we treat complex CLI.”


Dierk Scheinert, chief physician of the Angiology Department at the Park-Hospital Leipzig and principal investigator of the IN.PACT Amphirion registry, added: “It took us several years to develop adequate techniques to successfully reopen arteries below the knee, but we had no means of preventing restenosis for longer arterial segments. Drug-eluting stents are only feasible in short lesions. The drug-eluting balloon is the first method that brings down restenosis rates in complex CLI cases. An interesting observation is also the nature of the restenosis, if it appears after treatment with drug-eluting balloons: we see focal segments, not re-narrowing along the total artery. This makes reintervention less complex.”


Stefan Widensohler and Andrea Venturelli, co-founders of Invatec, welcomed the trial results: “This is the first data point on the use of drug-eluting balloons for complex below the knee applications, and it is a very positive data point. We feel encouraged to proceed with our high-level clinical trial programme on drug-eluting balloons which will provide even more definitive proof that Drug Eluting Balloons can benefit patients with arterial disease in the coronaries, in haemodialysis shunts and throughout the entire leg.”


INVATEC has initiated several clinical trials to assess their IN.PACT drug-eluting balloon line which includes four different balloon platforms. Drug-eluting balloons have the ability to deliver Paclitaxel to the vessel wall and inhibit tissue growth within the artery, a factor that leads to the re-narrowing of arteries. Previous trials conducted on the SFA and coronary arteries have shown outcomes favouring drug-eluting balloons.