BIOMAG-I study demonstrates low rate of in-scaffold late lumen loss at six months

Magnesium Resorbable Magnesium Scaffold

Angiographic and clinical data from the BIOMAG-I clinical study, presented at the 2023 Cardiovascular Research Technologies (CRT) conference (25–28 February, Washington DC, USA), have demonstrated a low in-scaffold late lumen loss (LLL) rate and a good safety profile with no scaffold thrombosis at six months.

Michael Haude (Rheinland Klinikum, Neuss, Germany), BIOMAG-I coordinating clinical investigator, presented the results of the study, a prospective single-arm study assessing the safety and clinical performance of the Dreams 3G (Biotronik) resorbable magnesium scaffold (RMS).

The trial showed a low proportion of malapposed struts after implantation, and at six months struts were no longer discernable. The intravascular imaging documented a preservation of the scaffold area with a low mean neointimal area.

Bioresorbable scaffolds have been developed to provide temporary mechanical support, while controlling neointimal proliferation over the vascular healing period and preventing long-term stent-related adverse events. Dreams 3G, Biotronik’s next-generation drug-eluting RMS is comprised of a proprietary Magnesium alloy and maintains a resorption time of 12 months, the company said in a press release. Compared to its predecessor Dreams 2G, it offers benefits such as reduced strut thickness and a higher radial strength, the press release adds.

“Dreams 3G did not only show a low in-scaffold late lumen loss rate, we could also see the preservation of the scaffold area with mostly well-embedded and resorbing scaffold struts,” said Haude. “This third-generation scaffold is on the level of contemporary drug-eluting stents while providing the benefits of a resorbable scaffold.”

The prospective BIOMAG-I clinical trial assesses the angiographic, clinical and safety performance of Dreams 3G of 116 patients with de novo coronary artery lesions. Fourteen clinics in eight European countries are taking part in the BIOMAG-I clinical trial with 20% of the patients presented with non-ST-elevation myocardial infarction (NSTEMI) and more than 75% with B2/C lesions.

“Dreams 3G RMS combines new features showing benefits for patient with de novo obstructive coronary artery disease in the BIOMAG-I trial,” said Georg Nollert, vice president medical affairs, Vascular Intervention at Biotronik. “As presented at the CRT congress by Masaru Seguchi, the OCT [optical coherence tomography] analysis of the BIOMAG-I revealed that underlying plaque tissue composition has no significant correlation with the very low coronary lumen loss of the scaffolded area at six-month follow-up. This suggests Dreams 3G provides sufficient radial strength and scaffolding time to achieve excellent results in lesions of fibrous, calcific, and/or lipidic nature.”


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