Biotronik’s Magmaris Resorbable Magnesium Scaffold Evaluated in BIOSOLVE-IV

May 17, 2022—Biotronik announced that new data on the safety profile of the company’s Magmaris resorbable magnesium scaffold (RMS) were revealed in the first cohort of the BIOSOLVE-IV study and from a subanalysis of BIOSOLVE-IV.

The BIOSOLVE-IV study is examining the clinical performance and safety of the Magmaris RMS to 5-year follow-up and is expected to run until 2025. The next full-cohort 2-year data are expected in fall of this year, noted the company. The latest safety data were presented in poster sessions at the EuroPCR 2022 conference held May 17-20 in Paris, France.

BIOSOLVE-IV study investigator Professor Jan Torzewski, MD, with Cardiovascular Center Oberallgäu-Kempten in Kempten, Germany, presented novel long-term data from the first cohort of the study.

According to the company, the evaluation of 1,075 patients enrolled across 23 countries confirmed a good safety profile for the Magmaris RMS up to 36 months in a real-world setting. The 36-month target lesion failure rate (TLF) of 8.2% is comparable to the low TLF rates of contemporary drug-eluting stents (DESs) such as Biotronik’s Orsiro (TLF, 8.2%) and Abbott’s Xience (TLF, 13.6%) in the BIOFLOW-V trial over the 36 months. The BIOFLOW-V data were presented and published in February 2020.

“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,” commented Prof. Torzewski in Biotronik’s press release. “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.”

Adrian Wlodarczak, MD, with Miedziowe Centrum Zdrowia SA in Lubin, Poland, presented the subgroup analysis, which also showed a good safety profile for the non–ST‐segment elevation myocardial infarction (NSTEMI), diabetes, and B2/C lesion subgroups up to 12 months.

In the company’s press release, Dr. Wlodarczak commented, “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 DES.” Dr. Wlodarczak referenced a study by Johann Bennett, MD, et al in Cardiovascular Revascularization Medicine, which was published online on October 1, 2021.