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| Magmaris bioresorbable scaffold--Courtesy of Biotronik |
Biotronik has received a CE mark for its bioresorbable scaffold. The device, intended for the treatment of coronary artery disease without using a permanent implant, is the first clinically proven magnesium scaffold.
The scaffold, marketed as Magmaris and previously known as Dreams (DRug Eluting Absorbable Metal Scaffold), demonstrated some advantages over polymer-based bioresorbable scaffolds in the Biosolve-II safety and performance trial. It is specifically indicated for coronary artery lesions, which have not previously been treated with angioplasty or stenting.
Bench tests showed it was easier to deliver to its target, requiring 40% less force to enter and cross a lesion, Biotronik said in a statement. Because it's made of magnesium, it is also less likely to separate from the blood vessel's wall and cause complications than its polymer-based counterparts. And the body reabsorbs magnesium more quickly.
"The body's ability to quickly resorb magnesium leads to a faster and therefore more desirable resorption time," said Dr. Stephan Kische of the Vivantes Cardiology Clinic in Berlin, in the statement. Drug-eluting bioresorbable stents are currently unavailable in the U.S. They are designed for the body to reabsorb after about a year and aim to one-up permanent stents in several ways: cutting late lumen loss (the decrease in size of the coronary artery after implantation), restoring vasomotion, and reducing restenosis. Magmaris joins two CE-marked bioresorbable stents: Abbott's ($ABT) Absorb and Elixir's DESolve. Both are polymer-based.
But it hasn't all been smooth sailing for Biotronik. While the Biosolve-II trial posted positive safety and performance data as well as positive long-term safety data, it followed the Biosolve-I trial, in which the device did not work as well as Abbott's Absorb. At the time, Biotronik deduced that paclitaxel was "not the optimal drug" for the device, and switched over to limus for the Bioresolve-II trial.
"CE mark approval for Magmaris opens a new horizon in the vascular therapeutic field," said Dr. Daniel Buehler, Biotronik's president of Vascular Intervention, in the statement. The German devicemaker is now recruiting patients for the Biosolve-III premarket study of the device to take place in Belgium, Germany, the Netherlands and Switzerland.