Introduction of brachytherapy to a German cath lab

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Introduction of brachytherapy to a German cath lab: How to meet the regulations within a reasonable time frame ?


Summary:

Presently, approximately 100 cath labs in the USA and over 20 cath labs in Europe perform intracoronary brachytherapy. In Germany, the first patients were treated with intracoronary afterloading in 1998. In this paper, we describe our experience with the approval processes for clinical research and for routine use with the Novoste BetaCath™ system. First, all major German authorities and laws involved in this process are named and explained. Then, the required steps for obtaining the license for research and routine use are described. Finally, we compare three systems (Beta-Cath™ Novoste, Gamma-IVT™ Cordis and BetaMed™ Boston Scientific) regarding their handling for security and maintenance checks, dosimetry verifications and leakage testing. With the increasing amount of data, obtaining the license for clinical routine use is presently possible in Germany within a reasonable time frame, provided the brachytherapy device has a CE certificate.


Address for correspondence:
Sigmund Silber, MD, FACC Professor of Medicine Dr. Müller Hospital Am Isarkanal 36 D-81379 München Tel: +49-89-7421510 Fax: +49-89-74215131 e-mail:silber@med.de