Biotronik Completes Enrollment in Biosolve-II Trial

Biotronik SE & Co. KG has finished enrolling subjects in its Biosolve-II trial, a clinical study investigating the safety and performance of DREAMS (DRug Eluting Absorbable Metal Scaffold).

DREAMS is an absorbable scaffold that combines the mechanical advantages of a metallic stent with a reliable bioabsorption profile that keeps the vessels open while avoiding the long-term disadvantages of permanent metal stents. The scaffold is made out of a magnesium alloy, coated with a bioabsorbable polymer matrix and an anti-proliferative Limus drug and is designed to be absorbed over time, leaving an uncaged vessel.

“Quite similar to a contemporary drug-eluting stent, but with the advantage of uncaging the vessel in the long run, DREAMS is a 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,” said Michael Haude, M.D., principal investigator of the study. Haude also is a professor of Internal Medicine and serves as Director of Medical Clinic – Lukas Hospital in Neuss, Germany.

There currently are two coronary scaffolds with CE mark, both based on polymer technology. Completion of enrollment in the Biosolve-II trial marks a significant step towards the commercial use of DREAMS as the first bioabsorbable magnesium scaffold, company bigwigs claim.

Building on the results of the Biosolve-I study, which demonstrated the safety of the first generation of DREAMS, Biosolve-II is a prospective, multi-center clinical trial evaluating the safety and performance of DREAMS in its improved design. A total of 122 patients were enrolled in the study with a primary endpoint of in-segment late lumen loss at six months.

“The refined DREAMS technology represents the optimal balance between vessel scaffolding, absorption profile and drug elution characteristics,” said Daniel Buehler, Ph.D., president of Biotronik’s Vascular Intervention unit. “Supported by the promising clinical data of the Biosolve-I study, I feel confident we will demonstrate the efficacy of this treatment.”

The Biosolve-II study has enrolled patients in Germany, Belgium, Denmark, the Netherlands, Switzerland, Spain, Brazil and Singapore.

Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.