Biotronik Begins BIOSOLVE Study of Its Drug-Eluting Absorbable Metal Stent

August 13, 2010—Biotronik AG (Bülach, Switzerland) announced that its DREAMS (Drug-Eluting Absorbable Metal Scaffold) device has been successfully implanted in the first patient as part of the first-in-man BIOSOLVE-I clinical study of this new treatment for coronary artery disease. BIOSOLVE-I is a prospective, nonrandomized study that will enroll patients at six centers in Germany, Belgium, the Netherlands, and Switzerland. Further enrollment in BIOSOLVE-I is planned to begin in all centers shortly.

According to the company, the DREAMS technology combines the acute mechanical advantages of a metallic stent with an antiproliferative drug, plus a reliable degradation profile that allows the vessel to slowly return to its natural physiology. The device is made of a biodegradable magnesium alloy combined with a slow-release drug. It is intended to open vessels and keep them from reclogging while avoiding the longer-term disadvantages associated with permanent metal stents.

Professor Michael Haude, MD, who performed the first implantation at Lukaskrankenhaus in Neuss, Germany 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.”