Biotronik's Magmaris Bioresorbable Scaffold Supported by BIOSOLVE-II Data

May 19, 2016—One-year data from the BIOSOLVE-II trial of Biotronik’s Magmaris magnesium-based, sirolimus-eluting bioresorbable scaffold were presented by Principal Investigator Prof. Michael Haude, MD, at the EuroPCR 2016 conference held May 17–20 in Paris, France. The data were concurrently published online by Prof. Haude et al in The European Heart Journal.

According to Biotronik, the study established the safety and clinical performance of the Magmaris device. Dr. Haude commented in the company’s press release, “These results offer the first confirmation of Magmaris’ longer-term safety and efficacy. BIOSOLVE-II demonstrates a promising potential of a magnesium-based approach to treating coronary artery disease as an alternative to polymer-based bioresorbable scaffolds.” Dr. Haude is with the Lukaskrankenhaus in Neuss, Germany.

According to Biotronik, BIOSOLVE-II evaluated the safety and clinical performance of Magmaris in 123 patients with de novo lesions who were enrolled in Germany, Belgium, Denmark, the Netherlands, Switzerland, Spain, Brazil, and Singapore. 

In the trial’s primary endpoint of in-segment late lumen loss (LLL) at 6 months, the investigators observed an LLL rate of 0.27 ± 0.37 mm. Additionally, Magmaris met its primary angiographic endpoint and demonstrated an outstanding safety profile at 6 months. The 6-month results were presented in 2015 and published by Prof. Haude et al  in The Lancet  (2016;387:31–39).

The voluntary 12-month follow-up reported at EuroPCR showed an LLL rate of 0.25 ± 0.22 mm. Device safety was also supported, with no stent thrombosis at 12 months. Furthermore, the low rate of target lesion failure of 3.4% was observed at 6 months, with no additional failure occurring between 6 and 12 months.

The company advised that CE Mark approval for the Magmaris device is pending. The scaffold’s magnesium backbone provides deliverability, strong radial support, and a fast resorption time of approximately 12 months. The Biolute coating consisting of a sirolimus drug and an excipient ensures a controlled drug release to control cell growth, stated Biotronik.