Biotronik, a leading manufacturer of cardio- and endovascular medical technology, 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).
Dr Michael Haude 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 superior 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.
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 6 months.
"The refined DREAMS technology represents the optimal balance between vessel scaffolding, absorption profile and drug elution characteristics," commented Dr Daniel Buehler, Biotronik President, Vascular Intervention. "As a global pioneer in bioabsorbable magnesium, we pride ourselves on soon being able to offer the world's first magnesium scaffold. Supported by the promising clinical data of the BIOSOLVE-I study, I feel confident we will demonstrate the efficacy of this groundbreaking treatment."
The BIOSOLVE-II study has enrolled patients in Germany, Belgium, Denmark, the Netherlands, Switzerland, Spain, Brazil and Singapore.