Elixir Medical reported 5-year outcomes for its bioresorbable DeSolve novolimus-eluting coronary scaffold system, as well as 6-month safety and efficacy results for its next-generation thin-strut DeSolve device.
The company’s DeSolve Nx clinical trial showed that at the 5-year end point, DeSolve boasts a 9% rate of major adverse cardiac events with no additional clinically-indicated target lesion revascularizations from 2 years to 5 years. The company also reported no definite scaffold thrombosis through 5 years.
The DeSolve scaffold degrades in 6 months and completely resorbs in 1 year.
At 6 months, DeSolve demonstrated mean late lumen loss of 0.20mm in the 126-patient clinical trial. Imaging results showed a statistically signficant increase of 9% in the lumen area between post-procedure and a 6-month follow-up with no late acquired incomplete scaffold apposition. Imaging also showed 99% strut coverage.
“Elixir’s DeSolve is the only BRS (bioresorbable scaffold) to accomplish early degradation and resorption of the scaffold while maintaining excellent and sustained effectiveness as evidenced by angiography and IVUS at 6, 18, and 36 months follow ups. In addition, the DeSolve scaffold demonstrated excellent long term clinical safety without any concerns for the patients,” co-principal investigator Dr. Stefan Verheye said in prepared remarks. “The continued low MACE rate with no late or very late scaffold thrombosis through 5 years, long after the scaffold is completely resorbed clearly differentiates DeSolve and demonstrates that not all BRS are the same.”
“Early degradation and early resorption are not only intuitively desirable, they are imperative for BRS technology to succeed and eliminate late scaffold events. Other technologies have had challenges of structural integrity and chronic recoil with their fast-degrading scaffolds, and reverted to much longer degradation and resorption profiles in order to solve those issues. However, long resorption profiles can potentially result in late and very late safety clinical events affecting patient outcomes,” CEO Motasim Sirhan added. “Elixir’s DeSolve stands out as the only technology to have elegantly solved this contradiction of providing early degradation and resorption while achieving excellent clinical efficacy and safety as demonstrated by the DeSolve Nx trial data.”
Elixir also reported 6-month safety and efficacy data for its next-generation thin-strut DeSolve Cx scaffold. The device has a strut thickness of 120µm and degrades in 6 months, with complete resorption in 1 year.
At 6 months, DeSolve Cx demonstrated late lumen loss of 0.19mm with no cases of scaffold thrombosis and no clinically-driven major adverse cardiac events. Imaging results showed low neointimal volume obstruction of 5% and an increase in scaffold and lumen area by 6 months.
“The outstanding clinical trial results of the DeSolve Cx with excellent safety and performance data position this product as a workhorse, next-generation bioresorbable scaffold system for clinicians seeking to improve clinical outcomes in a broad patient population,” Dr. Alexandre Abizaid said. “Since the Cx utilizes DeSolve’s proven technology for long term safety and efficacy, it is poised to be competitive with the best-in-class drug eluting stent systems, bringing the added advantage of being completely resorbed in the body and return the vessels to a de novo state.”
“The 6-month results for the DeSolve Cx clinical trial patients reinforce Elixir’s commitment of providing cardiologists with more deliverable and user-friendly coronary scaffolds for their clinical practice,” CEO Motasim Sirhan, said. “Elixir is proud to present 1 of the broadest and most innovative portfolios of safe and effective fully resorbable coronary scaffolds to help physicians confidently treat the patient’s blocked coronary arteries and return them to their de novo state.”
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