Biotronik has shared new data presented at EuroPCR 2022 (17–20 May, Paris, France) focused on the on the safety profile of its Magmaris resorbable magnesium scaffold (RMS) system.
BIOSOLVE-IV study investigator Jan Torzewski (Cardiovascular Center Oberallgäu-Kempten, Kempten, Germany), presented novel long-term data for the first cohort of the study. The evaluation of 1,075 patients across 23 countries confirmed a good safety profile for the Magmaris RMS up to 36 months in a real-world setting, Biotronik reports in a press release. At 8.2 %, the target lesion failure rate (TLF) at 36 months is comparable to the low TLF rates of a contemporary drug-eluting stent such as Orsiro (Biotronik) with 8.2% and Xience (Abbott) with 13.6% in the BIOFLOW-V trial over the same time period.
“Just as we have seen with the 24-month data, the first cohort 36-month data confirm the low scaffold thrombosis rates for the Magmaris RMS,” Torzewski commented on the results. “Our analysis demonstrates the low TLF rate of the Magmaris scaffold that has been shown in other studies like BIOSOLVE-II and -III with a follow-up of 36 months.”
A sub-group analysis presented by Adrian Wlodarczak, Miedziowe Centrum Zdrowia SA, Lubin, Poland, also showed a good safety profile for the NSTEMI, diabetes and B2/C lesion subgroups up to 12-months.
“A recent publication suggested that selected NSTEMI patients can be effectively and safely treated with Magmaris RMS after careful assessment. Now, our subgroup analysis with 383 NSTEMI patients affirms this recommendation, as the outcome demonstrates comparable TLF rates to those of a second-generation drug-eluting stent,” said Wlodarczak.
The BIOSOLVE-IV study examines the clinical performance and safety of the Magmaris RMS until five-year follow-up and is expected to run until 2025. The next full cohort two-year data is expected later this year.