TCT 2015: First-in-human results for Biotronik’s Dreams 2G absorbable stent

Early data on a fully bioabsorbable metal stent, the Dreams 2G made by Biotronik, showed that the device performed better and was just as safe as older iterations of the technology, researchers said today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.

The Dreams 2G is made of an absorbable magnesium alloy coated with a polymer impregnated with the anti-restenosis drug sirolimus; about 95% of the magnesium is absorbed after roughly 12 months. It’s the latest iteration of a device that began with fully dissolving bare-metal version, studied in the Progress trial, and evolved to the Dreams 1G drug-eluting stent evaluated in the Biosolve-I trial.

Results from Biotronik’s 123-patient Biosolve II study showed a late lumen loss rate of 0.27mm at 6 months, compared with LLL of 0.52mm in Biosolve I and 0.83mm in the Progress study. A subgroup of 30 patients who underwent intravascular ultrasound analysis showed that vessel wall thickening was reduced by 73%, according to the study, which was also published in The Lancet. The procedural success rate was 99% (122 of 123 patients) and the device success rate was 93% (122 of 131 patients).

“The unique design of the magnesium alloy stent provides the strength of metal with the long-term benefit of being absorbed into the body over time,” co-principal investigator Dr. Michael Haude of Lukaskrankenhaus Neuss in Germany said in prepared remarks. “The results from Biosolve-II demonstrate significantly improved in-segment late lumen loss at six months for this new stent technology compared to its precursor devices.”

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