Biotronik’s Dreams 3G Scaffold Shows Vascular Healing Process at 1 Year in OCT Analysis From BIOMAG-I FIH Study

September 1, 2023—Biotronik announced that new data from the BIOMAG-I first-in-human trial demonstrated the vascular healing process after the implantation of the company’s third-generation resorbable magnesium scaffold (RMS), Dreams 3G.

According to the company, a detailed intravascular optical coherence tomography (OCT) analysis demonstrated that 99.3% of the struts completely degraded at 1 year. Masaru Seguch, MD, from the German Heart Centre in Munich, Germany, presented the findings at the European Society of Cardiology’s ESC Congress 2023 held August 25-28 in Amsterdam, the Netherlands.

The company noted that earlier data showed favorable outcomes with regards to late lumen loss at 6 months (presented by Professor Michael Haude, MD, at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium) and at 12 months (presented by Prof. Haude at the 2023 EuroPCR conference).

The new analysis presented at the 2023 ESC Congress assessed the 12-month vessel healing profile. The analysis included patients from the multicenter BIOMAG-I trial who underwent OCT imaging pre- and postprocedure, at 6 and 12 months. At 1 year after implantation of the Dreams 3G RMS, the strut degradation rate was 99.3% as measured by OCT.

“We aimed to investigate the scaffold’s resorption process during the initial phase of vessel remodeling,” commented Professor Michael Joner, MD, in Biotronik’s press release. Prof. Joner, who is Deputy Director of Cardiology at the German Heart Centre in Munich, Germany, continued, “The degradation results indicate that vascular healing following Dreams 3G implantation appeared to be nearly complete at 12 months.”

Also at the 2023 ESC Congress, Prof. Haude, who is the BIOMAG-I Study Coordinating Clinical Investigator, presented another aspect of the trial. His research group investigated vasomotion after acetylcholine and nitroglycerine in 14 patients at the 12-month follow-up after device implantation. The assessment showed that vasomotion returned at 1 year in all tested patients.

As explained in the press release by Professor Georg Nollert, MD, Vice President, Medical Affairs, Vascular Intervention at Biotronik, “The return of vasomotion indicates that the scaffolded vessel segment has been uncaged. This supports our aim to offer a resorbable scaffold that disappears over time and leaves nothing behind but a healed vessel.”