Biotronik said today that new data from a European patient registry strengthen the clinical evidence for its Magmaris resorbable scaffold device, its procedure success and safety profile.
The target lesion failure (TLF) rate at 12 months was 4.7%. Cardiac death occurred in 0.1% of the 800 patients who received Magmaris and scaffold thrombosis in 0.6%. Further analysis of the data showed a device success rate of 97.1% and procedure success in 98.8% of the cases. Results from data on the first 800 patients from the BIOSOLVE-IV registry cohort were presented during the EuroPCR congress in Paris.
“Overall, BIOSOLVE-IV confirmed low TLF rates from previous trials in a real-world setting, including 17.8% non-ST-elevation myocardial infarction (NSTEMI heart attack) patients and 5.6% patients with bifurcation lesions,” said principal investigator Dr. Stefan Verheye, senior interventional cardiologist at Belgium’s Antwerp Cardiovascular Institute, in a news release.
Regional registries from Spain and Poland supported the positive clinical experience with the magnesium-based scaffold at EuroPCR, according to Biotronik. Based on one-year data of 78 patients in the Spanish registry and of 50 patients with acute coronary syndrome (ACS) in the Polish registry, the use of Magmaris was associated with procedural safety and promising clinical outcomes. The Polish study also showed low rates of TLR (4.3%) and zero scaffold thrombosis in 70 out of 150 ACS patients (NSTEMI) enrolled at 12 months.
Biotronik also announced first insights from its Dreams 3G scaffold, which was designed to provide improved mechanical properties and reduced strut thickness.
“Next-generation resorbable magnesium scaffolds should meet a number of requirements, including an increased scaffolding time,” said Dr. Michael Haude of Lukas Hospital, Neuss, Germany. “From what we have seen so far, Dreams 3G is on a good way to achieve these goals.”
“With additional data from three studies presented at this year’s EuroPCR, our magnesium scaffold technology has built an impressive body of clinical evidence,” added Biotronik corporate marketing senior VP Dr. Alexander Uhl. “We believe in the resorbable magnesium scaffold technology today and tomorrow. We also believe that this innovation should be available to selected patients now and will become a viable option for a broader range of indications in the future.”