Biotronik's Magmaris Resorbable Scaffold Shows Reduced Risk of Thrombosis

 

May 17, 2017—Biotronik announced data demonstrating that the company's Magmaris resorbable scaffold offers a reduced risk of thrombus formation compared with a polymeric scaffold (Absorb, Abbott Vascular) were presented at the EuroPCR 2017 conference in Paris, France.

Biotronik stated that Magmaris is a limus-eluting bioresorbable magnesium scaffold that provides deliverability, strong radial support, and a fast resorption time of approximately 12 months. The device features Biolute coating, which consists of a limus drug and an excipient, ensuring controlled drug release to inhibit cell growth similarly to the company's Orsiro hybrid drug-eluting stent.

In a late-breaking trial session at EuroPCR 2017, coordinating clinical investigator Michael Haude, MD, demonstrated that there was 0% incidence of definite or probable scaffold thrombosis with Magmaris after 2 years of clinical follow-up in the BIOSOLVE-II trial. During various talks at EuroPCR, physicians explored the different factors leading to the low risk of scaffold thrombosis with Magmaris, including low thrombogenicity, fast resorption time, and better endothelialization of the Magmaris magnesium scaffold compared with the Absorb polymeric scaffold.

Biotronik noted that several preclinical shunt trials by Ron Waksman, MD, and colleagues focused on the factor of acute thrombogenicity—the tendency of a material in contact with blood to form a clot.

According to the company, the first trial confirmed the low risk of thrombus formation with 86% less platelet coverage on the scaffold surface area with Magmaris compared with the Absorb polymeric scaffold. This study indicated lower thrombogenicity of the magnesium scaffold. The successful outcomes were later attributed to favorable design and the magnesium material of the Magmaris backbone. The data were presented for the first time by Michael Lipinski, MD, during EuroPCR’s Got Talent session.

Also at EuroPCR, Michael Joner, MD, presented findings on the importance of scaffold design and material on reducing thrombogenicity during the symposium “Magmaris Magnesium BRS: Safety and Performance of an Advanced and Innovative Technology.” Dr. Joner discussed the impact of the scaffold design on fluid dynamics of the blood flow, which is linked to platelet activation. He also showed preclinical data demonstrating 15% better endothelialization of Magmaris compared with the polymeric scaffold. The positive outcome of both factors potentially support the promising results of the thrombogenicity trial by Dr. Waksman et al.

In Biotronik's press release, Dr. Joner commented, “Material and design are essential contributors to the safety and performance of a scaffold. Our findings clearly show that Magmaris offers significantly lower thrombogenicity than the polymeric scaffold, helping us to increase patient safety.”

 

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