Enrollment Completed for BIOSOLVE-II Study of Biotronik's Dreams Bioabsorbable Magnesium Scaffold

February 19, 2015—Biotronik has announced the completion of enrollment in the BIOSOLVE-II trial, a clinical study investigating the safety and performance of its product, Dreams (drug-eluting absorbable metal scaffold). Prof. Michael Haude, MD, of the Lukaskrankenhaus in Neuss, Germany, served as the study’s principal investigator.

Dreams is a scaffold made out of a magnesium alloy coated with a bioabsorbable polymer matrix and an antiproliferative limus drug. It is designed to be absorbed over time, leaving an uncaged vessel.

BIOSOLVE-II is a prospective, multicenter clinical trial evaluating the safety and performance of Dreams in its improved design. A total of 122 patients in Germany, Belgium, Denmark, the Netherlands, Switzerland, Spain, Brazil, and Singapore were enrolled in the study with a primary endpoint of in-segment late lumen loss at 6 months. Completion of enrollment in the BIOSOLVE-II trial marks a significant step towards the commercial use of Dreams as the first bioabsorbable magnesium scaffold, the company stated.

“Quite similar to a contemporary drug-eluting stent, but with the advantage of uncaging the vessel in the long run, Dreams is a truly unique product that offers ease of deliverability and vessel adaptability. I look forward to allowing my patients to take advantage of it in my clinical practice,” commented Prof. Haude in the company’s press release.

The beginning of enrollment in BIOSOLVE-II was announced in October 2013. The trial builds upon the results of the BIOSOLVE-I study, which announced positive long-term safety results in June 2013.