Biotronik said today it won CE Mark for its Magmaris magnesium bioresorbable scaffold designed to treat coronary artery disease.
Data from the Biosolve-II trial of the stent was previously published in The Lancet, the company said, and 1-year data examining the safety of the device 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. 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,” Biosolve-II principal investigator Dr. Michael Haude of Germany’s Lukaskrankenhaus said in a press release.
Study data indicates the Magmaris device requires 40% less force to enter and cross lesions compared to polymer-based scaffolds, and 34% more force is transmitted on the delivery system end with the device.
“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,” Dr. Stephan Kische of Germany’s Vivantes Cardiology Clinic said in a prepared release.
“CE mark approval for Magmaris opens a new horizon in the vascular therapeutic field. 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,” Biotronik vascular intervention division prez Dr. Daniel Buehler said in prepared remarks.