Biotronik has announced the presentation of new full-cohort two-year BIOSOLVE-IV data. In a poster session at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA), principal investigator Johan Bennett (University Hospitals Leuven, Leuven, Belgium) presented the recent findings and highlighted the low target lesion failure (TLF) rate and the low scaffold thrombosis rate of Magmaris resorbable magnesium scaffold (RMS).
“Our latest clinical results show a continuation of previous study data and prove that Magmaris RMS has an excellent safety and efficacy profile up to 24 months1 with TLF rates comparable to contemporary available drug eluting stents,” said Bennett.
The PMS registry enrolled 2,066 patients worldwide with a large amount of complex patient groups including non-ST-elevation myocardial infarction (NSTEMI) (18.5%) and diabetic (21.6%) patients as well as cases with B2/C lesions (15.2%) and bifurcation lesions (4.6%).
The BIOSOLVE-IV study examines the clinical performance and safety of the Magmaris RMS up to a five-year follow-up and is expected to run until 2025.
Biotronik also announced the presentation of BIOMAG-I study results, the multicentre study assessing the angiographic, clinical and safety performance of its Dreams 3G RMS in patients with de novo coronary artery lesions. The data, which will be submitted to The Lancet, were presented during an innovation session, by Michael Haude (Rheinlandklinium Neuss, Neuss, Germany).
“The excellent safety profile of previous generations was maintained with low target lesion failure rates and no scaffold thrombosis case, while the angiographic late lumen loss (LLL) is now markedly improved”, said Haude. “The mean LLL of 0.21 mm with a median value of 0.13 mm is now compatible to the objective performance criteria defined as a median LLL of 0.18 mm for new generation DES2 in the report by the ESC task force on the evaluation of coronary stents. This is making Dreams 3G a potential alternative to permanent DES2.”
A total of 14 clinics in eight European countries are taking part in the BIOMAG-I clinical trial. The patient cohort includes 116 patients aged between 18 and 80 years with single de novo lesions in up to two coronary arteries. The study will run for a total of five years, assessing the primary endpoint of in-scaffold late lumen loss at six and 12 months, with follow-ups on the secondary endpoints at 12, 24, 36 and 60 months.