Biotronik's Magmaris Sirolimus-Eluting, Bioresorbable, Magnesium Scaffold Receives CE Mark Approval

June 15, 2016—Biotronik announced that the Magmaris sirolimus-eluting, bioresorbable, magnesium scaffold received European CE Mark approval for treating coronary artery disease without leaving a permanent implant behind.

In October 2015, the company announced that results from BIOSOLVE-II, a first-in-man study examining 6-month angiographic and clinical outcomes of the Magmaris device, were presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium. Concurrent with the presentation, the positive data from BIOSOLVE-II supporting the device’s safety and clinical performance were published by Principal Investigator Prof. Michael Haude, MD, et al online in The Lancet. 

In May 2016, the company announced that 1-year data confirming long-term safety from the BIOSOLVE-II trial were presented by Prof. Haude at the EuroPCR 2016 conference and concurrently published online by Prof. Haude, et al in the European Heart Journal.

In the company’s press release, Prof. Haude commented, “Now that clinical results have firmly established the safety and clinical performance of Magmaris, the magnesium-based scaffold could emerge as a strong alternative to currently available polymer-based scaffolds. Because it is made of magnesium, the scaffold has some unique advantages over polymer-based options in terms of deliverability and radial resistance following the implantation procedure.” Prof. Haude is with Lukaskrankenhaus in Neuss, Germany.

According to Biotronik, bench tests show that Magmaris requires 40% less force to enter and cross a lesion compared to a leading polymer-based scaffold for superior deliverability. The device also provides easier steerability through vascular anatomy, with 34% more force transmitted to the delivery system end compared to the polymer-based scaffold. 

The device’s magnesium backbone minimizes recoil after the procedure, allowing the scaffold to withstand external force within the vessel and enabling the vessel to remain open after implantation to prevent potential complications. In addition to these properties, Magmaris offers a faster resorption compared to polymer-based scaffolds, noted Biotronik.

Stephan Kische, MD, from Vivantes Cardiology Clinic in Berlin, Germany, stated in the announcement, “The body’s ability to quickly resorb magnesium leads to a faster, and therefore more desirable, resorption time. As the results of BIOSOLVE-II demonstrate, vessels can restore vasomotion as soon as 6 months after the procedure.”