EuroPCR: Magmaris Resorbable Magnesium Scaffold Confirms High Safety Profile at 3 Years With BIOSOLVE-IV Data
Two poster sessions at EuroPCR focus on Magmaris’ safety profile for the first cohort after three years and the full cohort subgroup analysis at one-year follow-up
Two posters presented at the EuroPCR provided new insights into the safety profile of BIOTRONIK's Magmaris® Resorbable Magnesium Scaffold (RMS). BIOSOLVE-IV study investigator Prof. Dr. Jan Torzewski, Cardiovascular Center Oberallgäu-Kempten, Germany, presented novel long-term data for the first cohort of the study. The evaluation of 1075 patients across 23 countries confirmed a good safety profile for the Magmaris RMS up to 36 months in a real-world setting. At 8.2 %, the target lesion failure rate (TLF) at 36 months1 is comparable to the low TLF rates of a contemporary DES such as Orsiro with 8.2% and Xience with 13.6% in the BIOFLOW-V trial2 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,” study author Prof. Dr. Jan 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.”
The subgroup analysis presented by Dr. Adrian Wlodarczak, Miedziowe Centrum Zdrowia S.A., Poland, also showed a good safety profile for the NSTEMI, diabetes and B2/C lesion subgroups up to 12-months. “A recent publication3 suggested that selected NSTEMI patients can be effectively and safely treated with Magmaris RMS after careful assessment4. Now, our subgroup analysis with 383 NSTEMI patients affirms this recommendation, as the outcome demonstrates comparable TLF rates to those of a second-generation DES,” said Wlodarczak.
The increasing body of clinical data confirms that RMS technology will play a significant role in the future of interventional cardiology and BIOTRONIK will keep leading and establishing this new absorbable therapy,” noted Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK.
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 in fall this year.
1. Torzewski J. Safety and performance of Magmaris at 36-months: BIOSOLVE-IV first cohort. Presented at: EuroPCR; 2022; ClinicalTrials.gov: NCT02817802
2. Kandzari D.E et al. Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization 3-Year Outcomes From the Randomized BIOFLOW V Trial. JACC: CARDIOVASCULARINTERVENTIONS. 2020. 13 (11): 1343-53. doi: 10.1016/j.jcin.2020.02.019.
3. Bennett J. et al, The resorbable magnesium scaffold Magmaris in acute coronary syndrome: an appraisal of evidence and user group guidance, CRM, 2021.
4. Please consult IFU for indications and use in special populations.
Magmaris is a trademark or registered trademark of the BIOTRONIK Group of Companies.
The Magmaris Resorbable Magnesium Scaffold is not currently commercially available in the United States.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.