IN.PACT drug-eluting balloons from Medtronic have demonstrated benefits in the two multicentre, randomised controlled trials in treating patients with coronary and peripheral artery disease.
The physician-initiated Balloon Elution and Late Loss Optimization (BELLO) study enrolled 182 patients across 15 hospitals in Italy to assess the IN.PACT Falcon drug-eluting balloon versus Boston Scientific's Taxus drug-eluting stent (DES), for safety and effectiveness in reducing late lumen loss (LLL) in small-vessel coronary artery disease.
At six months, with both devices eluting paclitaxel, the LLL rate associated with the IN.PACT Falcon drug-eluting balloon was superior to the Taxus DES and the rates of major adverse cardiac events (MACE) between the two groups were similar.
Antonio Colombo, Ospedale San Raffaele, Italy, spokesperson and co-principal investigator of the BELLO study, said the results of the BELLO study showed that Medtronic's IN.PACT Falcon drug-eluting balloon may be a viable alternative to drug-eluting stents in treating small coronary vessels that have narrowed due to atherosclerosis, in addition to vessels with in-stent restenosis.
Another randomised Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis (PACIFIER) study that enrolled 91 patients across three hospitals in Germany, showed that the IN.PACT Pacific drug-eluting balloon demonstrated advantages in preventing the superficial femoral artery (SFA) from renarrowing, compared to conventional, uncoated balloons.
The PACIFIER study also favoured the IN.PACT Pacific drug-eluting balloon on a composite of death, amputation and the need for target lesion revascularisation (TLR) at one year.
Martin Luther Hospital, Germany, department of radiology assistant medical director Michael Werk said that while preliminary drug-eluting balloon data from uncontrolled trials have been promising, the interventional community has awaited the results from a randomised trial to validate the clinical benefit of Medtronic's IN.PACT drug-eluting balloons.
"Earlier research has hypothesised that drug-eluting balloons can reduce late lumen loss, restenosis rates and the need for repeat target lesion revascularisation and now the one-year results of PACIFIER show, in a randomised forum, to what extent these results are possible," Werk added.
Image: Medtronic world headquarters, Fridley, Minnesota. Photo courtesy of: Bobak Ha'Eri.