Cardiologists use new drug-coated angioplasty balloon as first-choice restenosis treatment

Norfolk heart specialists among first to use new approach for long-term stenosis and restenosis treatment

Sequent Please from B Braun Medical provides a new approach to the long term treatment of restenosis and stenosis

Cardiologists at Norfolk and Norwich University Hospital are among the first in the UK to use a new ground-breaking drug-coated angioplasty balloon as a first-choice treatment for stenosis and restenosis.

The Sequent Please device from B Braun Medical is recommended by the National Institute for Health and Clinical Excellence (NICE) and the European Society of Cardiology for the treatment of in-stent restenosis after implantation of a drug-eluting stent.

Using the drug-eluting balloon where appropriate means you can avoid a permanent implant, treat the narrowing and provide the most-effective drug delivery to stop the vessel renarrowing

Extensive data from clinical trials in Germany has also demonstrated excellent results for using the drug-eluting balloon to treat stenoses and small vessel disease.

Dr Simon Eccleshall, consultant interventional cardiologist at Norfolk and Norwich University Hospitals NHS Foundation Trust, said: “We use Sequent Please for the majority of restenoses – and have used more than 200 balloons with excellent results.

“I was very impressed on a visit to Germany where doctors are using Sequent Please instead of metal stents where they can and I’ve now started doing the same.

“This method of treatment became known as DEB-only. It has to be better for the patient if they don’t have pieces of metalwork in them for the rest of their life. Using the drug-eluting balloon where appropriate means you can avoid a permanent implant, treat the narrowing and provide the most-effective drug delivery to stop the vessel renarrowing.”

I believe eventually we will end up with three treatment options – not just the traditional metal stent, but the drug-eluting balloon and perhaps bio-absorbable stents, which are available but are prohibitively expensive at present

Around three million people a year with blocked or narrowed arteries have a metal stent fitted, but in around 10% of cases the treatment does not work and blood vessels become blocked again.

The treatment of this in-stent restenosis (ISR) is a major problem in cardiology because, in those patients who have a new stent fitted, around 30% suffer a major cardiac event after three years, rising to 50% after five years.

A 12-month study revealed that 7.7% of heart patients treated with Sequent Please suffered a major adverse cardiac event, compared to 19% who had a drug-eluting stent fitted.

And, the latest data from a six-year trial found that only 9.3% of patients who were treated with Sequent Please had to have the same lesion re-treated, compared to 38.9% of patients who had a standard angioplasty balloon with no drug coating.

Liam Huson, B Braun Medical’s national sales manager for vascular technology, said: “SeQuent Please is a very exciting development for the cardiological community.

“With the current clinical evidence, SeQuent Please can be considered as a reasonable alternative to drug-eluting stents for selected patients with coronary artery disease. It is the most advanced solution for the treatment of patients with ISR and it represents currently the most promising therapeutic alternative to reduce the number of unnecessary stent implantations.”

He predicts cardiologists will increasingly move away from automatically opting for metal stents to treat coronary artery disease, adding: “I believe eventually we will end up with three treatment options – not just the traditional metal stent, but the drug-eluting balloon and perhaps bio-absorbable stents, which are available but are prohibitively expensive at present.”

Recommending Sequent Please NICE found that, after the first year of use, it was associated with cost savings of around £485,000 compared with standard ISR treatment.

Recently a landmark study has started in Germany to compare Sequent Please and a latest-generation drug-eluting stent for the treatment of lesions in small coronary arteries.

Huson said: “A positive outcome might have a significant impact on the market by reducing the number of stent implantations and associated co-medication time for patients.”

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