Biotronik’s Dreams 3G RMS Evaluated in BIOMAG-I FIH Study

March 16, 2023—Biotronik announced that 6-month angiographic and clinical data from the BIOMAG-I first-in-human (FIH) study of the company’s Dreams 3G next-generation drug-eluting resorbable magnesium scaffold (RMS) demonstrated a low in-scaffold late lumen loss (LLL) rate and a good safety profile with no scaffold thrombosis.

Additionally, a low proportion of malapposed struts after implantation was observed and at 6 months struts were no longer discernible. The intravascular imaging documented a preservation of the scaffold area with a low mean neointimal area, reported Biotronik.

Professor Michael Haude, MD, the trial’s coordinating clinical investigator, presented the latest results of BIOMAG-I at CRT 2023, the Cardiovascular Research Technologies conference held February 25-28 in Washington, DC. Prof. Haude is with Rheinland Klinikum in Neuss, Germany.

According to Biotronik, the prospective BIOMAG-I clinical trial is assessing the angiographic, clinical, and safety performance of the Dreams 3G RMS.

The trial is composed of 116 patients with de novo coronary artery lesions who were enrolled at 14 clinics in eight countries in Europe. In the trial population, 20% of the patients presented with non–ST-segment elevation myocardial infarction and more than 75% of patients presented with B2/C lesions. Completion of enrollment in the single-arm BIOMAG-I trial was announced by the company in March 2022.

“Dreams 3G did not only show a low in-scaffold LLL rate, we could also see the preservation of the scaffold area with mostly well-embedded and resorbing scaffold struts,” commented Prof. Haude in the company’s press release. “This third-generation scaffold is on the level of contemporary drug-eluting stents while providing the benefits of a resorbable scaffold.”

Biotronik’s Dreams 3G RMS, which is not is commercially available, is made of a magnesium alloy and maintains a resorption time of 12 months.

The company stated that compared to its predecessor Dreams 2G, it offers reduced strut thickness and a higher radial strength, as recently documented by Masaru Seguchi, MD, et al in EuroIntervention.

Georg Nollert, MD, Vice President Medical Affairs, Vascular Intervention at Biotronik, stated in the press release, “Dreams 3G RMS combines new features showing benefits for patient with de novo obstructive coronary artery disease in the BIOMAG-I trial. As presented at the CRT congress by Dr. Masaru Seguchi, the 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 6-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.”