Dr. Antonio Colombo had finished his presentation of 9-month data for Amaranth Medical‘s Aptitude sirolimus-eluting bioresorbable scaffold when an audience member asked about adverse events.
He told the EuroPCR attendee that they hadn’t seen any adverse events related to the device during the trial – and that’s unusual. Bioresorbable scaffolds, like Abbott‘s (NYSE:ABT) Absorb, have been plagued with a myriad of troubling data suggesting that the technology is linked to thrombosis and target lesion failure.
Newly-developed scaffolds are only just beginning to live up to thin-strut metallic drug-eluting stents, Colombo told the audience at this year’s EuroPCR meeting.
“It’s a little bit sad that we went through mega-trials with devices that are so 1st generation when we almost have in our pocket a new-generation device,” the co-principal investigator said.
At the end of the meeting, EuroPCR course director Dr. William Wijns defended bioresorbable stents as “an important option to optimize outcomes in patients whose needs are not adequately met with current devices,” but he ultimately concluded his statement with caution.
“Until the concerns about bioresorbable stents can be assuaged, current-generation BRS should not be preferred to metallic drug-eluting stents in routine clinical practice,” Wijns said.
To perform to the standards set by metallic drug-eluting stents, a bioresorbable scaffold needs to have thin struts while maintaining structural integrity. This sweet spot is where Amaranth Medical thinks it may have struck gold with its thin-strut bioresorbable scaffold.
At EuroPCR 2017, Colombo touted data for its 115-micron sirolimus-eluting bioresorbable scaffold. The 60-patient trial had a 98.3% device success rate, high scaffold stability and a 97% level of strut coverage at 9 months.
But the company also has a sub-100 micron device in the works and if it succeeds in clinical trials and makes it to the market, it would be 1 of a kind.
“In order for these devices to get any market traction, they really have to perform like a 1st-in-class, regular metallic drug-eluting stent,” Amaranth co-founder & CEO Kamal Ramzipoor told Drug Delivery Business News. “The closer you are to that, the greater market introduction you will have.”
Strut thickness affects a number of factors critical to a stent’s success, including its ability to navigate a patient’s vasculature and incorporate into the vessel wall.
“The longer it takes for the device to be incorporated into the vessel wall, the greater the chance of thrombosis because the obstacle causes stagnation of the blood flow,” Ramzipoor said. “So we think making the wall as thin as possible is extremely, extremely important.”
To make their bioresorbable scaffold both thin and strong, the company uses a proprietary polymer structure and processing method that Ramzipoor helped devise a decade ago when he co-founded the company.
Ramzipoor hopes that the company’s 115-micron device will win CE Mark clearance this year and that the sub-100 micron device will hit the European market by the end of next year.
Amaranth is in talks with potential distribution and financing partners, Ramzipoor said, and it hopes to eventually get the sub-100 micron bioresorbable scaffold into a large trial in the U.S.
“Depending on size of next round of financing, we would take the sub-100 micron into U.S. clinical trial,” he said.