Biotronik Announces Positive Long-Term Safety Outcomes From BIOSOLVE-I Study for DREAMS

June 7, 2013—The 2-year clinical data results from the BIOSOLVE-I study for DREAMS (drug-eluting absorbable metal scaffold; Biotronik, Inc, Berlin, Germany) were presented at EuroPCR. BIOSOLVE-I is a prospective, multicenter clinical trial evaluating the safety and efficacy of DREAMS. For the total of 44 patients who received follow-up, there was no cardiac death and no scaffold thrombosis. Target lesion failure (TLF) at 2 years was stable at 6.8% compared to 1 year with no additional events.

Vascular restoration of the scaffolded segment was also investigated. Angiography was performed to look at vascular angulation and return of motion, showing that vessel angulation was completely restored at 1 year.

“Vasomotion testing after acetylcholine and nitroglycerin already shows the uncaging effect of the DREAMS absorption at 6 months without an additional change at 1 year,” commented Prof. Michael Haude, MD. Dr. Haude is with Lukaskrankenhaus in Neuss, Germany, and is one of the study's investigators. “This uncaging effect seen in DREAMS is expected to be one of the main benefits of bioabsorbable scaffolds, aiding them in avoiding chronic stress and inflammation and allowing for the positive remodeling of the vessel segment.”

The final scaffold design is now undergoing completion and will be investigated in a larger clinical study that will be used for regulatory approval, due to start by the end of the year.