Stent developer Amaranth Medical is launching the MEND-II clinical trial to test its Fortitude Sirolimus-Eluting Bioresorbable Scaffold, a sign that companies large and small are keenly eyeing the new treatment paradigm for coronary artery disease involving stents that disintegrate within the body after a couple of years.
"The Fortitude Sirolimus-Eluting Bioresorbable Scaffold is designed to have comparable mechanical strength and durability to our bare bioresorbable scaffold, while also providing the controlled release of sirolimus to reduce the risk of restenosis," said Amaranth CEO Kamal Ramzipoor. "We look forward to advancing FORTITUDE through this clinical trial and initiating a study next year in Europe, both of which will support our planned application for CE Mark."
MEND-II is now enrolling patients in the South American nation of Colombia. Meanwhile, MEND-I results will be discussed shortly during today's session of the TCT cardiology conference in Washington, DC. Amaranth said the 13-patient trial met its 6-month primary endpoint of target vessel failure with no incidents of stent thrombosis or mechanical failure. Late lumen loss was similar to that of bare metal stents.
But the devices that are already CE marked (Abbott's Absorb and Elixir's DESolve) and surpassed even drug-eluting stents by demonstrating late lumen gain. However, an Amaranth spokeswoman pointed out to FierceMedicalDevices that it is too early to evalute that metric after 6 months since that is when the biodegradation typically begins. The data about late lumen gain is important at the one-year followup and is something to look for in the next Amaranth data dump.
FDA approval remains ever further off, not just for Amaranth but for all of the bioresorbable stent players. Abbott ($ABT) is farthest along the U.S. approval pathway and released data at TCT showing that its Absorb bioresorbable stent was broadly comparable to its drug-eluting Xience. Experts weren't overly concerned about data showing that the Absorb lagged behind Xience in some measures of acute efficacy and seemed intrigued by data showing that the device reduced angina postsurgery.
Unlike Abbott, Amaranth does not yet have a CE mark. But Boston Scientific ($BSX) gave the company a vote of confidence in the form an equity investment at the beginning of the year.
- read the release
Special Report: Leaders emerge in the race for the first U.S. bioresorbable stent - Abbott's Absorb BVS leads the pack
Editor's Note: This article has been updated to reflect perspective provided by an Amaranth spokeswoman.