Amaranth Medical touts early data for thin bioresorbable scaffold
Amaranth Medical presented nine-month imaging and safety data from patients treated with its 98-micron Magnitude bioresorbable scaffold at this year’s EuroPCR meeting.
For the 70 patients treated in the Renascent III trial, 97.3% experienced clinical device success. An interim analysis of 48 patients found a 6.3% rate of major adverse cardiac events, largely due to two cases of peri-procedural cardiac enzyme elevation, according to Amaranth. The binary restenosis rate was 7.9%, the company noted.
Amaranth also highlighted that to date, they have not observed any scaffold thrombosis.
These Renascent III results are early in the patient follow-up window. Additional, larger clinical studies would be needed to confirm these findings. Even so, they are promising and speak to the capabilities of the Amaranth polymer technology to develop scaffolds that are thin and strong enough to rival metal stents,” Dr. Alaide Chieffo, research director of the Interventional Cardiology Unit at Ospedale San Raffaele in Italy, said in prepared remarks.
“At 98 microns, the Magnitude scaffold has started to match the technical and mechanical performance of metallic drug-eluting metal stents,” added Dr. Juan Granada, president & CEO of the Cardiovascular Research Foundation and co-principal investigator of the Amaranth studies. “The thin struts on Magnitude allow the easier navigation of the scaffold through more tortuous anatomies; its mechanical strength allows operators to use a more ‘conventional’ deployment strategy.”
Amaranth also revealed two-year follow-up data for patients treated with its 115-micron device. Two-year data show no additional major adverse cadiac events and no incidence of scaffold thrombosis, the company touted. Amaranth expects to win CE Mark clearance for its Aptitude device this year.
Finally, the company also described plans to develop and test an 85-micron scaffold called Defiance. Amaranth plans to launch a clinical study of its latest device next year.
“There have been many failures in the development of BRS due to the limitations of first-generation polymer technology,” CEO Kamal Ramzipoor said. “However, the benefits of a bioresorbable scaffold remain compelling and we believe will drive interest in our product line, especially in our thin-walled Aptitude and two sub-100-micron scaffolds, Magnitude and Defiance. These BRS possess the desired characteristics to meet industry expectations of strength, flexibility and ease of use. We believe Amaranth is poised to become one of the few – if not the only – company with commercially viable sub-100-micron BRS.”