The novel coated balloon catheter improves coronary artery blood flow.
Berlin (March 30, 2009) – A novel method of expanding narrow coronary arteries has been presented at a Charité hospital press conference. The developers say the drug eluting balloon has the potential to revolutionize the treatment of coronary artery disease.
The novel drug eluting balloon (DEB) SeQuent® Please has now received CE certification and as such is approved for the treatment of narrowing of the coronary arteries. Like drug eluting stents, the new balloon catheter releases a cell growth-inhibiting drug into the walls of blood vessels, but does so much easier and quicker. It was developed in a research alliance between Prof. Ulrich Speck from Berlin Charité hospital and Prof. Bruno Scheller from Saarland University Hospital in Homburg/Saar, Germany. The DEB was advanced to serial production by B. Braun Melsungen AG.
According to Prof. Scheller, expansion of narrow coronary arteries with a conventional uncoated balloon is a fairly simple process. However, in many cases cell growth resumes and the expanded blood vessel closes again, in a process called restenosis. Restenosis is reduced by implanting a small metal tube called a stent. The restenosis rate is lowest with coated stents that release a drug which inhibits cell growth. The drawback of the drug eluting stent is delayed healing due to prolonged drug release, which means that patients have to take drugs to prevent blood clots for a long-term period. Otherwise, they would be at increased risk of blood clotting and heart attacks.
The drug eluting balloon catheter now presented is a promising alternative. Like drug eluting stents, the balloon is coated with a drug that inhibits cell growth. The balloon differs from stenting in that drug release does not continue for a prolonged period but is limited to the few seconds it takes to inflate the balloon. With this method, no foreign bodies that might cause blood clots remain in the vessel. The DEB opens up new options in situations where stenting is impossible or unwanted. It also removes the necessity of inserting a second stent in a restenosed stent.
According to Prof. Speck, transfer of a sufficient quantity of drug within a very short time is possible by adding an x-ray contrast medium, which improves absorption more than 20-fold. The newly authorized drug eluting balloon catheter is coated with a combination of paclitaxel and an x-ray contrast medium called iopromide. During expansion, it releases within seconds enough paclitaxel into the wall of the artery to reduce cell growth significantly and so prevent restenosis.
The drug eluting balloon’s efficacy has been confirmed in a number of clinical trials. According to Dr. Martin Unverdorben, a professor from the Clinical Research Institute at the Rotenburg an der Fulda Cardiovascular Center and recently Medical Director & Corporate Vice President Scientific Affairs, B. Braun Medical, USA, SeQuent® Please is a new treatment modality with successful proof of long-term efficacy in the treatment of certain forms of coronary artery stenosis.
