Biotronik’s Dreams 3G Resorbable Magnesium Scaffold Studied in BIOMAG-I Trial

March 1, 2022—Biotronik announced final enrollment in the first-in-man BIOMAG-I clinical trial, a prospective single-arm study assessing the safety and clinical performance of the company’s third-generation Dreams 3G resorbable magnesium scaffold (RMS).

A total of 14 clinics in eight European countries are taking part in BIOMAG-I. The patient cohort includes 116 patients (aged 18-80 years) with single de novo lesions in up to two coronary arteries. The study will assess the primary endpoint of in-scaffold late lumen loss at 6 months, with follow-ups at 12, 24, and 36 months.

Professor Michael Haude, MD, with Rheinland Klinikum at Neuss Lukaskrankenhaus in Neuss, Germany, is the study’s Coordinating Clinical Investigator. The study’s Principal Investigator is Professor Javier Escaned, MD, who is with Hospital Clinico San Carlos in Madrid, Spain

According to the company, Dreams 3G is Biotronik’s next-generation RMS after the Magmaris device. The scaffold is made from the company’s Biomag magnesium alloy for improved mechanical properties. The implant supports the patient’s vessel for a limited period only, which is critical for vessel healing. Approximately 12 months after the implantation, the magnesium is resorbed.

Compared to its predecessor, the Dreams 3G RMS provides a larger portfolio of 15 sizes to enable the treatment of a broader range of vessels and patients. The new scaffold also has thinner struts and a new marker concept for better visibility, stated Biotronik

“Based on my extensive experience with RMSs, Dreams 3G represents a very promising evolution for resorbable technology,” commented Prof. Haude in Biotronik’s press release. “With its larger size matrix, thinner struts, and improved mechanical performance, Dreams 3G has the potential to provide a broader range of clinical benefits than previously available scaffolds.”

Prof. Haude continued, “The BIOMAG-I study is investigating whether these design improvements will translate into the expected clinical benefits. The study has now achieved a major milestone by completing the enrollment; primary endpoint data on in-scaffold late lumen loss at 6-month follow-up are intended to be presented later this year.”