BIOTRONIK‘s Magmaris, the first clinically proven magnesium bioresorbable scaffold, has received CE mark approval, granting physicians a new option for treating coronary artery disease without leaving a permanent implant behind.
Positive data regarding the device’s safety and clinical performance from the BIOSOLVE-II trial was previously published in The Lancet; one-year data confirming long-term safety was recently published in The European Heart Journal.
“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,” BIOSOLVE-II principal investigator Dr. Michael Haude of the Lukaskrankenhaus, Neuss, Germany, commented. “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
Bench tests show that Magmaris is superior to a polymer-based scaffold in terms of deliverability, as it requires 40 percent less force to enter and cross a lesion, makiing it easier for physicians to steer through vascular anatomy, as 34 percent more force is transmitted to the delivery system end.
Additionally, Magmaris’s magnesium backbone minimizes 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.
Magmaris also offers a faster resorption compared to polymer-based scaffolds. Vessels can restore vasomotion as soon as six months after the procedure, researchers said.
“CE mark approval for Magmaris opens a new horizon in the vascular therapeutic field,”Dr. Daniel Buehler, president, vascular intervention at BIOTRONIK, said. “We strongly believe that only a resorbable metal alloy can provide patients the distinctive advantages capable of addressing their future needs.”
The scaffold’s magnesium backbone offers strong radial support and a fast resorption time of approximately 12 months, according to BIOTRONIK, which is headquartered in Berlin, Germany, and represented in more than 100 countries.