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BIOTRONIK Announces Positive Long Term Safety Outcomes from BIOSOLVE-I Study for DREAMS
BIOSOLVE-I is a prospective, multi-center clinical trial evaluating the safety and efficacy of DREAMS, the Drug Eluting Absorbable Metal Scaffold. For the total of 44 patients who received follow-ups, there was no cardiac death and no scaffold thrombosis. Target Lesion Failure (TLF) at two years was stable at 6.8% compared to one year with no additional events.
DREAMS is part of an innovative treatment option for patients with coronary artery disease. In contrast to existing permanent stents that cage the vessel segment over the course of the patient's life, this device, based on a magnesium backbone, is designed to be absorbed over time, leaving nothing behind but a naturally restored vessel.
Vascular restoration of the scaffolded segment was also investigated as part of the BIOSOLVE-I study. Angiography was performed to look at vascular angulation and return of motion, showing that vessel angulation was completely restored at one year. The return of vasomotion (free contraction/dilation of the vessel) at six months was observed with no further change at one year.
"Vasomotion testing after acetylcholine and nitroglycerin already shows the uncaging effect of the DREAMS absorption at six months without an additional change at one year," commented Prof. Haude. "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."
Building on these results, the final scaffold design is now undergoing completion and will be investigated in a larger clinical study due to start by the end of the year. This study will be used for regulatory approval.
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