UPDATED Oct. 13, 2015 with expanded comments from Biotronik.
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 results of Biosolve-II confirm that the Biotronik magnesium scaffold is both a safe and effective option for treating coronary artery disease, and establish it as the 1st clinically-proven magnesium-based bioresorbable scaffold,” co-principal investigator Dr. Michael Haude of the Lukaskrankenhaus, Neuss, Germany, said in prepared remarks. “The device’s favorable safety profile, as demonstrated by the lack of any scaffold thrombosis (ST) at 6 months from implantation, was especially remarkable.
“The Biotronik magnesium scaffold shows advantages over synthetic polymer-based scaffolds as it can be inflated in a single step. It is based on a natural element widely present in the human body, and the magnesium-based properties promote a faster and simpler implantation procedure,” Haude said. “Additionally, the magnesium is absorbed within 12 months, faster than polymer-based bioresorbable scaffolds, while vasomotion is observed at 6 months. I look forward to this device attaining CE Mark, so I can use it in my patients also outside of trials.”
“As a global pioneer in magnesium technology in the cardiovascular field, we pride ourselves on being the first company to gain clinical evidence supporting the safety and clinical performance of our magnesium-based scaffold with this ground-breaking trial,” added Biotronik vascular intervention president Dr. Daniel Buehler. “These highly promising results further establish Biotronik as an innovator, and open a new chapter in the field of vascular intervention.”