Biotronik’s Magmaris Resorbable Scaffold Evaluated at 2 Years in BIOSOLVE-IV Registry

May 18, 2021—Biotronik announced that 2-year follow-up data from the first cohort of the BIOSOLVE-IV real-world registry were presented by Professor Jan Torzewski, MD at the virtual EuroPCR conference. The company stated that the findings strengthen the clinical evidence for the Magmaris resorbable magnesium scaffold (RMS) as a therapy option for patients with coronary artery disease.

According to Biotronik, BIOSOLVE-IV is evaluating the clinical performance and long-term safety of the Magmaris RMS in a real-world setting. In the first cohort of 1,075 patients enrolled at more than 100 clinical sites, the target lesion failure (TLF) rate was 6.6% at 24 months. The outcomes demonstrated a very good safety profile with no increase in scaffold thrombosis between the 12-month and 24-month follow-up and a cardiac death rate of 0.5%.

The company noted that pooled results from the BIOSOLVE-II and BIOSOLVE-III trials (n = 174) recently demonstrated TLF rates of 6.3% at 36 months. The BIOSOLVE-II trial alone demonstrated a TLF rate of 8% at 60 months for the Magmaris RMS. No definite or probable scaffold thrombosis was observed in these studies.

“Our results confirm the low TLF rate of the Magmaris scaffold that we have seen in other long-term studies, such as BIOSOLVE-II and -III,” commented Prof. Torzewski, a Principal Investigator of the registry, in the company’s press release. “Furthermore, this bioresorbable scaffold is safe and comparable to various second-generation drug-eluting stents on the market.”