May 17, 2016 — Biotronik presented 12-month data from the BIOSOLVE-II trial during a Hotline Session at EuroPCR 2016. The study established the safety and clinical performance of Magmaris, what the company calls the world’s first clinically proven magnesium-based, sirolimus-eluting bioresorbable scaffold. Full one-year data from the prospective, international first-in-human trial has been published in The European Heart Journal concurrently with the Hotline Session.
“These results offer the first confirmation of Magmaris’s longer-term safety and efficacy,” stated BIOSOLVE-II principal investigator Dr. Michael Haude of the Lukaskrankenhaus, Neuss, Germany. “BIOSOLVE-II demonstrates a promising potential of a magnesium-based approach to treating coronary artery disease as an alternative to polymer-based bioresorbable scaffolds.”
BIOSOLVE-II is the first trial to evaluate the safety and clinical performance of Magmaris. One hundred twenty-three patients with de novo lesions were enrolled in Germany, Belgium, Denmark, the Netherlands, Switzerland, Spain, Brazil and Singapore. The trial’s primary endpoint was in-segment late lumen loss (LLL) at six months, with an LLL of 0.27 ± 0.37 mm observed at six months. The voluntary 12-month follow-up now reports an LLL of 0.25 ± 0.22 mm. Magmaris had previously met its primary angiographic endpoint and demonstrated an outstanding safety profile at six months; the results were published in The Lancet.
Particularly encouraging from the perspective of device safety was the total absence of stent thrombosis at 12 months. Furthermore, a low rate of target lesion failure (TLF) of 3.4 percent was observed at six months, with no additional TLF occurring between six and 12 months.
Due to the scaffold’s magnesium backbone, it offers novel benefits that only a metallic scaffold can offer such as desired deliverability, strong radial support and a fast resorption time of approximately 12 months. In addition, the BIOlute coating consisting of a sirolimus drug and an excipient ensures a controlled drug release to control cell growth similar to Orsiro, Biotronik’s hybrid drug-eluting stent.
Magmaris is CE mark pending.
For more information: www.biotronik.com