Biotronik announces positive long-term safety outcomes from BIOSOLVE-I study

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Results from the BIOSOLVE-I study that were presented at the EuroPCR have demonstrated the excellent safety profile of the DREAMS drug-eluting absorbable metal scaffold. Michael Haude, Lukaskrankenhaus, Neuss, Germany, one of the study’s investigators, presented the results.

BIOSOLVE-I was a prospective, multicentre clinical trial evaluating the safety and efficacacy of the drug-eluting absorbable metal scaffold. For the total of 44 patients who at follow-up, there was no cardiac death and no scaffold thrombosis.Target lesion failure, according to a press release, at two years was stable at 6.8% compared to one year with no additional events.

DREAMS is a treatment option for patients with coronary artery disease. According to the press release, 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 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 drug-eluting absorbable metal scaffold absorption at six months without an additional change at one year,” commented 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 remodelling of the vessel segment.”

The final scaffold design is reported to have undergone completion and will be investigated in a larger clinical study due to start by the end of the year. This study is intended to be used for regulatory approval.

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