Biotronik receives CE Mark approval for Magmaris bioresorbable scaffold

Biotronik has announced that its Magmaris bioresorbable scaffold has been granted European CE Mark approval.

The device is the first clinically-proven bioresorbable magnesium scaffold for the treatment of coronary artery disease, providing superior deliverability and faster resorption compared to polymer-based scaffolds.

Positive data regarding the device's safety and clinical performance from the BIOSOLVE-II trial was published in The Lancet, showing that it requires 40 percent less force to enter and cross a lesion than a leading polymer-based scaffold.

It is also easier to steer through vascular anatomy, as 34 percent more force is transmitted to the delivery system end. Other advantages include its magnesium backbone, which minimises recoil following the procedure, meaning it can withstand external force within the vessel.

Dr Daniel Buehler, president for vascular intervention at Biotronik, said: "We are eager to bring our magnesium scaffold to market, as we strongly believe that only a resorbable metal alloy can provide patients the distinctive advantages capable of addressing their future needs."

This comes after the firm reported clinical data underlining the efficacy and safety of its Orsiro hybrid drug-eluting stent earlier this month.