News | February 19, 2015

Biotronik Completes Enrollment in BIOSOLVE-II Trial

Clinical study evaluating safety, performance of company’s bioresorbable magnesium stent

Biotronik, DREAMS, BIOSOLVE-II trial, bioresorbable stent, magnesium

Image courtesy of Biotronik Inc.

February 19, 2015 — Biotronik announced the completion of enrollment in the BIOSOLVE-II trial — a clinical study investigating the safety and performance of DREAMS (DRug Eluting Absorbable Metal Scaffold).  Michael Haude, M.D., of the Lukaskrankenhaus, Neuss, Germany, principal investigator of the study, commented:

"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."

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

There are currently only 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.

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 (LLL) at six months.

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

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