EuroPCR 2017: Magmaris Resorbable Scaffold Shows Safety and Stability in 24-Month Data; No Instances of Scaffold Thrombosis
Pooled Analysis of BIOSOLVE-II and BIOSOLVE-III Studies Reveals Consistent and Rates of Target Lesion Failure For Up to Two Years
Twentyfour month data from the BIOSOLVE-II study reveal the long-term safety, efficacy and stability of BIOTRONIK’s Magmaris resorbable magnesium scaffold. Presented during a late-breaking trial session at EuroPCR 2017, the findings demonstrated the continued safety and efficacy of Magmaris at two years, serving as the first results since 95% resorption of the magnesium backbone. The presentation also revealed high procedure success at six months in the BIOSOLVE-III trial. Findings from both studies are being published concurrently in EuroIntervention.
“As we collect results at each stage of the BIOSOLVE studies, we are given increasing reason to believe that Magmaris will continue to be heralded as an effective solution in the long term,” stated coordinating clinical investigator Dr. Michael Haude, Lukaskrankenhaus, Neuss, Germany. “With no reported instances of scaffold thrombosis, BIOSOLVE-II results confirm that the magnesium scaffold is a safe solution for patients even after the scaffold has been completely resorbed, differentiating it from polymer-based scaffolds.” During his presentation, Dr. Haude showed that there was 0% definite and probable scaffold thrombosis with Magmaris at six, 12 and 24 months across the cohort of patients with de novo coronary artery lesions.
Dr. Haude also presented the pooled six-month data of the BIOSOLVE-II and BIOSOLVE-III studies. The combined results demonstrated consistent and low target lesion failure at 3.3% and no incidence of definite or probable scaffold thrombosis, further confirming the safety and efficacy of Magmaris. Clinical follow-up for BIOSOLVE-III will continue for up to three years.
“As the first clinically-proven resorbable magnesium scaffold (RMS), it is essential to generate positive long-term clinical evidence to reinforce physician confidence in Magmaris,“ said Dr. Alexander Uhl, BIOTRONIK Vice President Marketing Vascular Intervention. “We intend to continue to invest in this new proven technology in order to provide patients with the safest and most effective care. Corresponding with this, we are pleased to announce that BIOSOLVE-IV is underway, with over 200 patients currently enrolled for Magmaris implantation. This global study will include more than 1,000 patients with a five-year follow-up for longer-term evaluation of the magnesium scaffold.“
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.