Real-World Data Confirms Long-Term Safety and Efficacy of BIOTRONIK’s Bioresorbable Scaffold

New, long-term follow-up data from the BIOSOLVE-IV real-world registry strengthens the clinical evidence for BIOTRONIK’s Magmaris^® Resorbable Magnesium Scaffold (RMS) as a therapy option for patients with coronary artery disease. Prof. Jan Torzewski, head physician at the Cardiovascular Center Oberallgaeu-Kempten in Germany, presented the two-year results for the first cohort at the virtual EuroPCR meeting.¹

BIOSOLVE-IV investigates the clinical performance and long-term safety of the Magmaris RMS in a real-world setting. In the first cohort of 1,075 patients, from more than 100 clinical sites in total, the target lesion failure² (TLF) rate was 6.6% at 24 months. The outcomes demonstrated a very good safety profile, no increase in scaffold thrombosis between 12-month and 24-month follow-ups³ and a cardiac death rate of 0.5%.

“Our results confirm the low TLF rate of the Magmaris scaffold that we have seen in other long-term studies, such as BIOSOLVE-II and -III,” said Prof. Jan Torzewski, one of the registry’s principal investigators.

Pooled results from the BIOSOLVE-II and BIOSOLVE-III trials (n=174) recently demonstrated TLF rates of 6.3% at 36 months⁴ and the BIOSOLVE-II trial alone demonstrated a TLF rate of 8.0% at 60 months⁵ for the Magmaris RMS. No definite or probable scaffold thrombosis was observed in these studies.

“Furthermore, this bioresorbable scaffold is safe and comparable to various second-generation drug-eluting stents on the market,” commented Prof. Torzewski.

Indeed, bioresorbable scaffolds aim to provide comparable performance to existing metallic drug-eluting stents, while delivering complete scaffold resorption within a certain time period to facilitate complete vessel healing.⁶ The Magnesium backbone dissolves in the body approximately 95% at one year after implantation.⁷

“The data shows that BIOTRONIK’s Magmaris RMS is an innovative, bioresorbable scaffold that can provide a true therapy option for coronary artery disease,” commented Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. “We are excited to examine the benefits that our next generation magnesium scaffold, DREAMS 3G, will provide for both patients and physicians, patient enrollment for the BIOMAG-I first-in-man study is ongoing.”

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References:

1 Torzewski J, Safety and performance of Magmaris at 24-month follow-up of BIOSOLVE-IV. Poster presented at virtual EuroPCR, May 18, 2021.

2 Target lesion failure is defined as composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization and emergent coronary artery bypass grafting.

3 Four out of five subjects had an early antiplatelet interruption prior to six months.

4 M. Haude, H. Ince, S. Kische, et al., Sustained safety and performance of the second-generation sirolimus-elutingabsorbable metal scaffold: Pooled outcomes of the BIOSOLVE-II and -III trials at 3 years, CardiovascularRevascularization Medicine (2020), https://doi.org/10.1016/j.carrev.2020.04.006.

5 Haude M., Long-term clinical data of the BIOSOLVE-II study with the drug-eluting absorbable metal scaffold in thetreatment of subjects with de novo lesions in native coronary arteries - BIOSOLVE-II, Presented at euroPCR e-course2020

6 Bennett J et al. Magmaris resorbable magnesium scaffold for the treatment of coronary heart disease: overview of its safety and efficacy, Expert Review of Medical Devices, DOI: 10.1080/17434440.2019.1649133.

7 Joner M, Ruppelt P, Zumstein P, et al. Preclinical Evaluation of Degradation Kinetics and Elemental Mapping of First and Second Generation Bioresorbable Magnesium Scaffolds. EuroIntervention. 2018. pii: EIJ-D-17-00708. DOI: 10.4244/EIJ-D-17-00708.

Magmaris is a trademark or registered trademark of the BIOTRONIK Group of Companies. The Magmaris Resorbable Magnesium Scaffold is not currently commercially available in the United States.