Biotronik’s scaffold is now approved for use in Europe


Biotronik’s bioresorbable magnesium scaffold—Magmaris—is now CE mark approved, meaning it is now one of three bioresorbable scaffolds available on the European market (alongside Abbott Vascular’s Absorb and Elixir Medical’s Desolve). Magmaris is the first bioresorbable device to have a magnesium scaffold.

A press reports that bench tests have shown that Magmaris is superior to a leading polymer-based scaffold in terms of deliverability, as it requires 40% less force to enter and cross a lesion. It adds that device’s magnesium backbone minimises recoil following the procedure, meaning that the scaffold is able to withstand external force within the vessel. This ensures the vessel remains open following implantation to prevent potential complications. Positive data for the device’s safety and clinical performance, from the BIOSOLVE-II trial, was published in The Lancet; one-year data confirming long-term safety was recently published in The European Heart Journal.

BIOSOLVE-II principal investigator Michael Haude (Lukaskrankenhaus, Neuss, Germany) says: “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.”

According to the press release, Magmaris offers a faster resorption compared with polymer-based scaffolds. “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 six months after the procedure,” says Stephan Kische (Vivantes Cardiology Clinic, Berlin, Germany).