A significant milestone has been reached in the development of a new therapy for patients suffering from coronary artery disease, with the first ever successful implantation of the Biotronik DREAMS (Drug Eluting Absorbable Metal Scaffold) as part of the first-in-man clinical study Biosolve-I.
DREAMS technology is revolutionary in that it combines for the first time, the acute mechanical advantages of a metallic stent – a biodegradable magnesium alloy – with a slow release, anti-proliferative drug, plus a reliable degradation profile that allows the vessel to slowly return to its natural physiology. The new device is intended to open vessels and to keep them from re-clogging, while avoiding the longer term disadvantages associated with permanent metal stents, such as late stent thrombosis.
Dr. Michael Haude, head of the team that performed the first implant at the Lukaskrankenhaus in Neuss has commented, “The first implantation went very well and I am excited to see how DREAMS will show its efficacy in the follow-up and in future procedures of the Biosolve-I trial.”
Biosolve-I is a prospective, non-randomised study that will enrol patients in Germany, Belgium, The Netherlands and Switzerland. In testing the efficacy of the product, Biotronik considers DREAMS to be the systematic next step forward after conventional PTCA, BMS (Bare Metal Stent) and DES (Drug Eluting Stent) technologies. Marketing and sales vice president Alain Aimonetti believes DREAMS will initiate a true revolution in interventional cardiology. “Looking at our vast amount of preclinical data, I am optimistic for the outcome of this study,” he said.