UK's First Drug-Eluting Balloon Dilatation Catheter Launched

Main Category: Cardiovascular / Cardiology
Article Date: 26 Jan 2009 - 4:00 PDT

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VascuMed launches the UK's first 'second generation' drug-eluting balloon - DIOR® paclitaxel-coated coronary balloon dilatation catheter - at Advanced Cardiovascular Intervention meeting, London (28 - 30 January 2009)

The DIOR paclitaxel-coated coronary balloon dilatation catheter has the potential to treat both high-risk and low-risk percutaneous coronary intervention (PCI) patients while reducing adverse events and restenosis versus conventional drug-eluting stents (DESs). The development of the so-called 'second generation' drug-eluting balloons affords significant benefits.

Developed by Dr Michael Orlowski - CEO and Director of Eurocor, Germany -DIOR's structure overcomes several disadvantages associated with the polymeric matrices used in DESs, potentially reducing the chance of thrombosis, inflammation and delayed re-endothelialisation. As a result, post-operative anti-platelet therapy may be minimised and percutaneous coronary intervention (PCI) may therefore be performed in high-risk diabetic and renal disease patients.

Since the European launch of DIOR, 7000 interventions have been performed across continental Europe. Dr Asif Qasim, Consultant Interventional Cardiologist at Mayday University Hospital and King's College Hospital has been involved with procedures using DIOR at Colombus Hospital, Milan, Italy.

Dr Qasim said: "DIOR offers a valuable new option to treat patients in whom stent implantation is not desirable - including small vessels, in-stent restenosis, bifurcation side-branch, and possibly acute ST-elevation MI."

One-quarter of DESs can result in restenosis. Conventional stent-in-stent drug-delivery techniques used in restenosis may result in arterial stiffness. DIOR offers a novel technique for drug delivery to the in-stent lesion, which minimises arterial stiffening and provides homogenous drug delivery to 100% of the in-stent coronary lesion. Furthermore when treated with DIOR, in-stent coronary lesions remain accessible for re-intervention and show reduced repeat in-stent restenosis versus conventional stent-in-stent interventions.

"We are very excited to be bringing this new technology to the UK. DIOR provides the cardiologist with a revolutionary method to successfully treat a number of previously difficult to treat patients," commented Maurice McCone, Managing Director, VascuMed.

DIOR technical information

-- The DIOR drug-eluting balloon is loaded with 3.0ųg paclitaxel/mm2 into the microporous balloon surface.

-- Insertion of the DIOR catheter is performed as with any typical PTCA catheter.

-- During insertion the three-folded structure of the DIOR balloon protects the drug from early wash-off.

-- Inflation of the DIOR drug-eluting balloon for 45-60 seconds distributes the full, clinically-effective dose of paclitaxel equally over 100% of the coronary lesion:

- proximal and distal areas adjacent to the lesion are also treated.

-- The balloon can be inflated several times:

- 35% of the dose is eluted with the first 20 second inflation
- a further 35% of the dose is then eluted with the second inflation.

-- No paclitaxel is found in the peripheral circulation from 10 minutes up to 48 hours after DIOR dilatation.

-- Resistance of the endothelium to paclitaxel and its lack of efficacy on non-proliferating vascular smooth muscle cells, minimises the risk of non-specific drug-action.

About VascuMed

VascuMed supplies a comprehensive range of angioplasty products for interventional cardiologists, including product training and support services across the UK and Ireland.

VascuMed

About Eurocor

Eurocor is a company with expertise in the field of interventional coronary devices. Their research and manufacturing operation is based in Bonn, Germany.

Eurocor

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