Biotronik’s Dreams 3G RMS Evaluated in 12-Month Data From European BIOMAG-I FIH Study

June 2, 2023—Biotronik recently announced that the first-in-human (FIH) BIOMAG-I study of the company’s new-generation Dreams 3G resorbable magnesium scaffold (RMS) showed significantly lower in-scaffold late lumen loss (LLL) than its predecessor at 12 months as well as excellent safety and efficacy.

The prospective BIOMAG-I clinical trial is assessing the angiographic, clinical, and safety performance of the Dreams 3G RMS in 116 patients with single de novo lesions in up to two coronary arteries; of these, 20% presented with non–ST-segment elevation myocardial infarction and > 75% presented with B2/C lesions. The patients were enrolled at 14 clinics in eight European countries.

The company noted that investigators adhered to the 4P protocol for RMS implantation (patient selection, adequate predilatation, proper sizing, and adequate postdilatation).

The Dreams 3G device is composed of Biotronik’s Biomag magnesium alloy and maintains a resorption time of 12 months. Compared to the Dreams 2G predecessor device, it offers benefits such as reduced strut thickness and longer vessel support, stated the company.

Professor Michael Haude, MD, the BIOMAG-I study’s coordinating clinical investigator, presented the results in the late-breaking trial session at the EuroPCR conference held May 16-19 in Paris, France. Prof. Haude is from Rheinland Klinikum in Neuss, Germany.

The BIOMAG-I 12-month-results were simultaneously published by Prof. Haude et al in EuroIntervention.

According to the company, the BIOMAG-I 1-year follow-up data confirmed the safety profile of the Dreams 3G RMS with a low target lesion failure rate of 2.6%. There was no reported cardiac death, myocardial infarction, or scaffold thrombosis. After completion of the resorption, the in-scaffold LLL was 0.24 ± 0.36 mm, comparable to contemporary drug-eluting stents (DES).

“At the end of the scaffold resorption, at 12 months the data showed that the Dreams 3G scaffold has an excellent safety and efficacy profile,” commented Prof. Haude in the company’s press release. “The LLL is not just 38% better than the predecessor but also on a level of a contemporary DES making it a valuable alternative to DES.”

In March 2023, the company announced that the 6-month angiographic and clinical data from the BIOMAG-I, which demonstrated a low in-scaffold LLL rate and a good safety profile with no scaffold thrombosis, were presented by Prof. Haude at CRT 2023, the Cardiovascular Research Technologies conference held February 25-28 in Washington, DC. Final enrollment in the study was announced on March 1, 2022.