A next-generation drug-eluting coronary balloon dilatation catheter could provide a new option for high-risk patients requiring percutaneous coronary intervention (PCI). It could treat patients immediately after they have suffered a heart attack, and could also be of benefit in patients with diabetes and renal disease.

The DIOR paclitaxel-coated balloon, made by Eurocor of Bonn, Germany, also promises to reduce adverse coronary events and restenosis in some arteries versus conventional drug-eluting stents. So says Dr Asif Qasim, consultant interventional cardiologist at King's College Hospital, London, who conducted an independent evaluation of the device with Dr Antonio Columbo, of the cardiac catheterisation laboratory at the San Rafaele Hospital in Milan, Italy.

"This balloon technology provides a valuable new option for coronary angioplasty patients. There are certain patients and lesions into which you would prefer not to implant a stent for various reasons. In those situations – which perhaps constitute 10% of cases [approximately 8,000 PCI procedures each year in the UK] – a balloon that can deliver anti-restenotic drugs to the site is very useful," Dr Qasim told Clinica.

The balloon structure is loaded with 3.0µg paclitaxel/mm2 and has three longitudinal folds, protecting the drug from washing off before it is deployed. Placement of the device for 45-60 seconds distributes a clinically-effective dose equally over the entire coronary lesion, in addition to proximal and distal areas adjacent to the lesion. Alternatively, it can be inflated several times, releasing 35% of the dose on each of the first and second inflations.

While the micro balloon technology will not eliminate the need for stents entirely, the developers say that its potential to reduce thrombosis, inflammation and delayed re-endothelialisation means that post-operative anti-thrombotic therapy may be minimised – making it an option for more patients, as well as for those with occlusions in very small arteries that remain untreatable with stents.

"The starting point in terms of lesions are the small arteries, those less than 2.25mm, because the risk of restenosis is very high with a stent. There is also evidence to show that where there is an existing stent in an artery which has restenosis, patients do better with a drug-eluting balloon than implanting another stent within the existing stent," Dr Qasim said. This so-called stent-in-stent intervention is associated with a high restenosis rate.

He added: "Not only could it represent optimal life-saving treatment for many more high-risk patients, but we could also use these tiny balloons in arteries with secondary blockages, as occurs after around 20% of angioplasty procedures. It's an important area which needs further study but, given the evidence we've seen, I think drug-eluting balloons could become one channel of standard PCI practice in selected patients and lesions."

VascuMed, a UK-based company specialising in angioplasty products, has secured an exclusive distribution deal with EuroCor for the UK market, and will launch the device this week at the Advanced Cardiovascular Intervention Congress, in London. The firm says it is the first CE-marked device of its kind to be made available to UK patients.

However, that could change; Berlin-based Biotronik has a similar technology waiting in the wings, and B Braun is also working on drug-coated balloons.