The company reports: Excellent Six-Month Safety and Efficacy Results for Next-Generation Thin-strut DESolve® Cx Novolimus Eluting Bioresorbable Coronary Scaffold System also presented
Elixir Medical Corporation, announced excellent 5-year clinical data from the DESolve Nx international pivotal clinical trial for the CE Mark-approved, fully bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System.
Presented y Stefan Verheye, MD, PhD, ZNA Middleheim Hospital, Antwerp, Belgium, and Co-Principal Investigator of the DESolve Nx trial,at EuroPCR, in Paris, France.
The DESolve Nx clinical trial demonstrated that at the five-year end point, long after the full bioresorption of the DESolve scaffold, DESolve continues to show a low overall MACE rate (9.0%) with no additional CI-TLRs (clinically-indicated target lesion revascularizations) from years 2 through 5, and no definite scaffold thrombosis through 5 years.
The company describes: DESolve scaffold achieves early degradation in 6 months and near complete resorption of the scaffold mass in one year. The DESolve Nx clinical trial confirmed complete resorption of the scaffold using OCT at the 36-month angiographic follow up. The mean lumen area measured by IVUS imaging at 6 months was maintained through 36 months demonstrating sustained efficacy of treatment with the DESolve scaffold.
“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,” said Dr. Verheye. “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,” explained Motasim Sirhan, Chief Executive Officer of Elixir Medical. “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.”
The DESolve Nx pivotal trial enrolled 126 patients at 13 centers in Europe, Brazil and New Zealand. At 6 months, Elixir’s DESolve demonstrated excellent mean late lumen loss of 0.20±0.32 mm as measured by QCA. IVUS imaging results demonstrated a statistically significant increase of 9% in the lumen area between post procedure and 6-month follow-up with no late acquired ISA (incomplete scaffold apposition). OCT imaging results demonstrated an impressive 99% strut coverage with a thin and uniform 0.10 mm neointimal layer and confirmed no late acquired ISA.
The fully bioresorbable DESolve scaffold system, developed from a proprietary and proven poly-L Lactide (PLLA)-based polymer, provides optimal strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus. The unique attributes of the DESolve scaffold system include (a) its ability to show lumen area increase at six months demonstrating vascular restoration; (b) degrade in six months and near complete resorption in one year with the intent to eliminate late and very late scaffold-related events; (c) its ability to maintain radial strength and vessel support for the necessary period of vessel healing while degrading; and (d) its ability to have a wide margin of over-expansion.
Excellent Six-Month Safety and Efficacy Results for Next-Generation Thin-strut DESolve® Cx Novolimus Eluting Bioresorbable Coronary Scaffold System
Elixir Medical also announced excellent six-month primary endpoint safety and efficacy data of the DESolve Cx Clinical Study at EuroPCR. Professor Alexandre Abizaid, M.D., Ph.D., of The Instituto Dante Pazzanese de Cardiologia, Brazil, and Co-Principal Investigator of the DESolve Cx Trial, presented the clinical and imaging results to a packed audience of the international cardiology community gathered in Paris for the annual meeting of the European Association for Percutaneous Cardiovascular Interventions. The DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold leverages the proven DESolve technology, has a strut thickness of 120µm, and degrades in six months with near complete resorption in one year, returning the patients’ coronary vessel to its normal de novo state. The DESolve Cx scaffold is more deliverable and designed to address the needs of a broader patient population.
At 6 months, Elixir’s DESolve Cx demonstrated excellent late lumen loss of 0.19 ± 0.25 mm, no cases of scaffold thrombosis, and no (0%) clinically-driven Major Adverse Cardiac Events. Imaging results by IVUS (intravascular ultrasound) demonstrated low neointimal volume obstruction of 5% and an increase in scaffold and lumen area between baseline and six months, confirming early uncaging of the vessel. Excellent acute scaffold strut apposition and embedding was observed with intravascular Optimal Coherence Tomography (OCT) imaging. A demonstration of vasomotion (response of the blood vessel to stimulus) of the scaffolded vessel utilizing nitroglycerin infusion was also accomplished at 6-month follow-up.
The DESolve Cx clinical trial is a 50-patient, single-arm, multi-center evaluation of the Elixir’s next-generation, thin-strut DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System. The patients were enrolled in Europe and Brazil, and will continue to be followed-up through two years.
“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,” said Dr. Abizaid. “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,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “Elixir is proud to present one 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.”
The fully bioresorbable DESolve™ Cx scaffold system, developed from a proprietary and proven poly-L Lactide (PLLA)-based polymer, provides optimal strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus. The unique attributes of the DESolve Cx scaffold system include its ability to (a) show lumen area increase at six months demonstrating vascular restoration; (b) degrade in six months and near completely resorb in one year with the intent to eliminate late and very late scaffold-related events; (c) maintain radial strength and vessel support for the necessary period of vessel healing while degrading; and (d) have a wide margin of over-expansion.