Elutax is clinically Proven Drug eluting balloon for use in Coronary

Latest 2015 Published data shows great mid term results-  CORTESE- Elutax STUDY



DOWNLOAD  It-   Abstract Alessandro S. Bortone

This is a study abstract on our new ElutaxWhat is important to note is that these results were taken at 15-16 months FU. Many other DEB’s for recurrent DES ISR are taken at 7-8months. Therefore these represent not only more realistic and useful data but demonstrate the real life effectiveness of the coating.


Drug-eluting balloon in restenosis of drug-eluting stents: Medium term follow-up

Scope of the work:  Although the use of drug-eluting stents (DES) has dramatically reduced the incidence of restenosis compared with bare-metal stent (BMS), in-stent restenosis (ISR) using DES is a phenomenon which still exists, and becomes clinically relevant due to the prevalence of complex lesions. The optimal therapeutic strategy of intra-DES ISR remains hotly debated.

Medicated drug eluting balloons (DEB) are a good treatment option, but little data are currently available on medium term follow-up and potential of intra-DES ISR predictors.

Materials and methods: From May 2010 to July 2013, we retrospectively studied 70 patients who underwent 71 procedures using a medicated balloon (ELUTAX SV) for DES ISR.

The characteristics of the treated lesions were classified as intrastent, multifocal and DES stent marginal; focal and diffuse proliferative lesions were therefore not included in our population. In all patients, we performed a pre-dilatation with an appropriately gauged balloon.

The drug treatment plan provided for dual anti-platelet aggregation using acetyl salicylic acid + clopidogrel for three months following treatment with DEB and only acetyl salicylic acid chronically.

All patients were provided with an instrumental clinical follow-up (cardiological examination with stress test and/or myocardial scintigraphy) at 6 and 12 months, and further telephone follow-ups every six months.


Our population is characterised by a mean age of 67.6 years, with 42{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} diabetic patients, 70{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} dyslipidaemic patients, 30{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} patients with a family history of ischemic heart disease, 45{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} patients with previous myocardial infarction, 24{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} patients with previous bypass, and 10{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} patients with chronic renal failure.

The 70 patients treated with DEB underwent our clinical observation for acute coronary syndrome (ACS) in 43{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} of cases (30 patients), for stress angina in 30{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} of cases (21 patients), and for instrumental ischemia in 27{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} of cases (19 patients).

The treated vessels were divided as follows: 6 common trunk (CT), 25 anterior interventricular (AIV) 4 diagonal branch (D1), 12 circumflex (CX), 6 marginal obtuse (MO) 1 CX posterior lateral (PLCX), 15 right coronary artery (RCA), 1 DX posterior lateral (PLDX) and 1 vein graft.

The Intra-DES ISR were pre-treated in 65{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} of cases with non-compliant balloons, and 38{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} with cutting balloons; in 80{2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} of cases the diameter of the pre-dilation balloon was greater than or equal to 0.25 mm, the stent restenosis diameter.

The medicated balloon (ELUTAX SV) was chosen in the appropriate size to reach the vessel wall, the duration of inflations with the medicated balloon was 60 seconds.

The average length of the treated lesions was 16.2 mm (standard deviation 3.1 mm) and the average length of the medicated balloons was 18.8 mm (standard deviation 3.4 mm). There were no non-procedural adverse events and in no case was it necessary to implant, post- DEB, any additional stent.

During the clinical and instrumental follow-up period (median 13.3 months), there were no deaths nor strokes, nor intrastent thrombosis, nor hospitalisations for heart failure.

Sixteen patients underwent coronary angiography as a result of the following clinical presentations: 4 patients with non-ST segment elevation myocardial infarction (NSTEMI), 8 as a result of unstable angina and 4 following stress angina and instrumental ischemia.

Mace Table

The angiographic examination has highlighted restenosis during DEB in a total of 10 patients (14.2 {2aeca2b538baccd230e37847ef06b6966f49e2913368dea7f0fdefc5f0eaeba0} of the population treated with DEB) which is broken down as follows: 3 NSTEMI, 5 unstable angina, and two residual ischemia.


In the last 24 months Paclitaxel coating technology has advanced. We use smaller drug crystals for a higher drug uptake and SV (sustained value) meaning the drug being active in the vessel wall for over a month. No one has a more effective drug coating/transfer for PTCA. This stable coating  has allowed us to make balloons as small as 1.5mm up to 14mm in diameter. We have a sealing layer that protects the drug from wash off effect. This coating on a very flexible, low profile RX balloon makes them ideal for distal lesions particularly in CTO cases

Many years Experience

The first generation Elutax appeared around seven years ago,  It was also the first generation “Dior balloon”. Much has changed.  Our partner Aachen Resonance  has more experience than any other drug eluting balloon (DEB) manufacturer. They overcame the technical challenges of previous generations of DEBs and now have a highly effective, stable coating on a high quality balloon. With the Hydrogel layer preventing wash off, you can take time reaching the lesion site. The new Elutax Sustained Value DEB is excellent for coronary use.

Order code ElutavSV xxxxx

Rapid exchange .014 wire: All through a 4F sheath min 5F Guide (6F for some guides) : Proximal shaft 2.2F distal 2.6-3.5f depending on version.

DRUG TRANSFER TIME- 15-30 seconds at Nominal pressure.

Large vessel  stenosis?  See our large diameter central vessel range of balloons.

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