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First Polish drug-coated balloon catheter

June 6, 2013

Physicians from the Centre for Cardiovascular Research and Development American Heart of Poland in cooperation with Balton Ltd. successfully completed preclinical trials of first Polish drug-coated balloon catheter (PAX®, Balton Ltd.) used in the treatment of vascular diseases. This is an important step towards extending the innovative method in Poland.

Preclinical trials were performed by a team of specialists from American Heart of Poland led by Assoc. Prof Piotr Buszman, MD, PhD, Assoc. Prof. Krzysztof Milewski, MD, PhD and Aleksander Żurakowski MD, PhD, under the supervision of Prof. Paweł Buszman, MD, PhD and Dr. Juan Granada, MD from Cardiovascular Research Foundation (NY, USA). The research was carried out at the Centre for Cardiovascular Research and Development (AHP). Balton Ltd. was the sponsor of the study.

The innovative feature of the balloon catheter is its brand-new coating that consists of microcrystalline paclitaxel. We have proved that the restenosis is inhibited after local administration of drugs eluted from the coating and additionally in comparison with normal balloon angioplasty it ensures better healing. The balloon is also very well tolerated by the artery wall. We believe that the solution can significantly improve the results of minimally invasive treatment of lower limbs atherosclerosis, ensure long-term patency and consequently it reduces the risk of amputation – says Assoc. Prof. Piotr Buszman – Preclinical Research Director

The results of the innovative research carried out by Polish physicians from AHP were presented at the Conference of European Association of Percutaneous Cardiovascular Interventions (EuroPCR) in Paris as well as published in the Journal of Catheterization and Cardiovascular Interventions.

The next step aimed at broadening the use of the first Polish balloon catheter in everyday practice are clinical trials which are planned to be conducted in the Centre for Cardiovascular Research and Development American Heart of Poland in Bielsko-Biała.

Launching of the new balloon catheter will increase the access of Polish patients to this innovative method of treatment of vascular diseases like it was observed many years ago when first polish coronary stent made of stainless steel was launched – says Assoc. Prof. Krzysztof Milewski General Director.

Recently published information by the Ministry of health Republic of Poland shows that cardiovascular diseases since more than 50 years still remains the most important cause of death of Polish citizens. Due to the involvement of Polish cardiologists as well as increasing access to modern medical technologies in the past 10 years the mortality caused by heart attack has significantly decreased. Unfortunately other cardiovascular diseases are still a huge problem.

Only few people are aware that the direct cause of almost 70% of lower limbs amputations are vascular diseases, which affects also young people. New technologies that are tested CCRD AHP will certainly allow us to improve these statistics – explains Alexander Żurakowski MD, PhD, Clinical Research Director.

American Heart of Poland has been engaged for many years in research activities connected with testing of new medical devices and drugs as well as methods of cardiovascular diseases treatment. Our projects enabled the introduction into clinical practice devices such as: first polish coronary stent made of stainless steel 316L “Chopin”, coronary stent made of cobalt chrome alloy “KOS”, first antiproliferative drug eluting stent (coating made of paclitaxel) “Shellak”, thin-strut stent made of cobalt chrome alloy “Coflexus” and coronary stent eluting sirolimus “Alex”. These solutions significantly influenced the development of interventional cardiology in Poland – not only by raising the safety and the comfort of patients (reduction of complications and repeated revascularisations, shorter recovery time) but also by improvement of the accessibility to modern technologies and in a significant prices reduction.

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