Biotronik Presents Data for Magmaris and Dreams 3G Resorbable Magnesium Scaffolds

September 20, 2022—Biotronik announced the presentation of 2-year data from the full cohort of the BIOSOLVE-IV registry evaluating the company’s Magmaris resorbable magnesium scaffold (RMS). The company advised that the findings demonstrated low rates of target lesion failure (TLF) and scaffold thrombosis. The company also announced the presentation of data from BIOMAG-I, which is evaluating the company’s Dreams 3G RMS.

The BIOSOLVE-IV registry is a postmarket study examining the clinical performance and safety of the Magmaris RMS with up to 5 years of follow-up. The study is expected to run until 2025.

According to the company, the registry enrolled 2,066 patients worldwide with a large number of complex patients, including those with non–ST-segment elevated myocardial infarction (18.5%) and diabetes (21.6%), as well as patients with B2/C lesions (15.2%) and bifurcation lesions (4.6%).

Professor Johan Bennett, MD, presented the data in a poster session at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

“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 months with TLF rates comparable to contemporary available drug-eluting stents,” commented Prof. Bennett in Biotronik’s press release. Prof. Bennett is a coronary interventionalist at University Hospitals Leuven in Leuven, Belgium. Previously, safety data from the first cohort of the BIOSOLVE-IV study and from a subanalysis of BIOSOLVE-IV were presented in poster sessions at the EuroPCR 2022 conference held May 17-20 in Paris, France. The Magmaris RMS received European CE Mark approval in 2016. It is currently not available for use in the United States.

Also at TCT 2022, Professor Michael Haude, MD, presented results from the BIOMAG-I clinical trial during the TCT Innovation session. The data will be submitted to The Lancet for publication, noted the company. BIOMAG-I is a first-in-human, prospective, multicenter, single-arm study assessing the angiographic, safety, and clinical performance of the company’s third-generation Dreams 3G RMS in patients with de novo coronary artery lesions.

“The excellent safety profile of previous generations was maintained with low TLF rates and no scaffold thrombosis case, while the angiographic late lumen loss (LLL) is now markedly improved,” commented Prof. Haude in the company's press release.

Prof. Haude continued, “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 DES in the report by the European Society of Cardiology task force on the evaluation of coronary stents. This is making Dreams 3G a potential alternative to permanent DES.”

Prof. Haude, who is with Rheinland Klinikum at Neuss Lukaskrankenhaus in Neuss, Germany, serves as Coordinating Clinical Investigator of the BIOMAG-I trial. On March 1, 2022, the company announced final enrollment in the trial.

According to Biotronik, 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 18 to 80 years with single de novo lesions in up to two coronary arteries. The study will run for a total of 5 years, assessing the primary endpoint of in-scaffold LLL at 6 and 12 months, with follow-ups on the secondary endpoints at 12, 24, 36, and 60 months.

The new scaffold is made from Biotronik’s Biomag magnesium alloy for improved mechanical properties and is designed to provide higher radial force, maintained resorption time of 12 months, reduced strut thickness, and improved radiopacity with a new marker concept. A portfolio of 15 sizes will enable the treatment of a broader range of vessels and patients, stated Biotronik.