Invatec, an innovator of interventional products, has reported the first clinical results of the Drug Eluting Balloon (DEB), IN.PACT Amphirion, for complex critical limb ischemia (CLI) in below the knee (BtK). Preliminary results indicated a reduction in restenosis rate by application of the Drug Eluting Balloon.

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 favoring Drug Eluting Balloons, said the company.

Andrej Schmidt, lead investigator from the Park Hospital Leipzig, said: “In our experience, 69% of clinical limb Ischemia patients with long lesions show restenosis after 3 months. The Drug Eluting Balloon was able to bring this number down to 31%. Considering the mean lesion lengths of 17 cm and 58% rate of total occlusions prior to intervention, these results have the potential to change the way we treat complex CLI.”

Dierk Scheinert, professor and chief physician of the Angiology Department at the Park-Hospital Leipzig and principal investigator of the IN.PACT Amphirion register, said: “It took us several years to develop adequate techniques to successfully re-open BtK arteries but we had no means of preventing restenosis for longer arterial segments.

“Drug eluting stents are feasible in short lesions. The Drug Eluting Balloon is the method that brings down restenosis rates in those complex CLI cases. An interesting observation is also the nature of the restenosis, if it appears after treatment with DEB: we see focal segments, not re-narrowing along the total artery. This makes re-intervention less complex.”

Stefan Widensohler and Andrea Venturelli, co-founders of Invatec, said: “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 program on DEB which will provide even more definitive proof that Drug Eluting Balloons can benefit patients with arterial disease in the coronaries, in hemodialysis shunts and throughout the entire leg.”

Invatec has initiated several clinical trials to assess their IN.PACT DEB line, which includes four different balloon platforms.