BIOTRONIK today 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*, 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*. 123 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.
“BIOSOLVE-II has paved the way for a novel magnesium bioresorbable scaffold which offers outstanding deliverability without leaving an implant behind,” commented Dr. Daniel Buehler, BIOTRONIK President, Vascular Intervention. “The current clinical evidence will be augmented with a robust post-market clinical program, including the BIOSOLVE-IV trial.”
About Magmaris*
Magmaris* is a sirolimus-eluting bioresorbable magnesium scaffold exclusively available from BIOTRONIK. 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 proven 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.
* CE mark pending
“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*. 123 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.
“BIOSOLVE-II has paved the way for a novel magnesium bioresorbable scaffold which offers outstanding deliverability without leaving an implant behind,” commented Dr. Daniel Buehler, BIOTRONIK President, Vascular Intervention. “The current clinical evidence will be augmented with a robust post-market clinical program, including the BIOSOLVE-IV trial.”
About Magmaris*
Magmaris* is a sirolimus-eluting bioresorbable magnesium scaffold exclusively available from BIOTRONIK. 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 proven 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.
* CE mark pending
