PARIS--(BUSINESS WIRE)--Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced two-year results from the BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results, for the first time, demonstrate significant reduction in adverse events and clinical advantage of the DynamX bioadaptor in target lesion failure (TLF) and secondary endpoint of target vessel failure (TVF) driven by sustained low event rates with DynamX compared to a two-fold increase in DES. The data were presented at a late-breaking clinical session during the EuroPCR 2024 conference in Paris.
Clinical results show statistically significant benefit with DynamX bioadaptor over Resolute Onyx at two years:
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65% reduction in TLF rate (1.9% versus 5.5%; p=0.046). The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX compared to DES, respectively:
- Cardiovascular death (0% versus 1.8%)
- Target vessel myocardial infarction (0.9% versus 1.9)
- Target lesion revascularization (0.9% versus 2.3%)
- 68% reduction in TVF rate (1.9% versus 6.0%; p=0.029) in DynamX compared to DES
Two-year lesion subset results:
- 78% reduction (1.9% vs.8.7%; p=0.028) in TLF rate in left anterior descending (LAD) artery lesions treated with DynamX bioadaptor versus treatment with DES
- Small vessels (<2.75mm) TLF rate was 0% vs. 3.5% in DynamX versus DES, respectively
- Long lesions (>23mm) TLF rate was 0% vs. 2.3% in DynamX versus DES, respectively
“These two-year results from the BIOADAPTOR RCT trial are very exciting—unlike anything we’ve ever seen before—and represent a new treatment category for patients living with coronary artery disease. The TLF rate curve separation validates how the bioadaptor’s unique design and mechanism of action restores the vessel viability, including the LAD vessel. It does this by restoring hemodynamic modulation validating the previously demonstrated superior imaging outcomes at one year. These data show that bioadaptor offers sustained, very low event rates across all major endpoints, making it a superior option compared to DES,” said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “The 78% magnitude of reduction in clinical events in LAD lesions is particularly important, as the artery provides 50% of a heart muscle’s blood supply and undergoes significant hemodynamic movement during every cardiac cycle. Restoring its function is clearly of significant benefit.”
The DynamX bioadaptor is different from current standard of care therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. The locked phase establishes maximum flow lumen and restores blood flow. Unique to bioadaptor, the unlocked and separation phase of bioadaptor’s helical strands releases the vessel while maintaining the established blood flow lumen. The final phase provides adaptive dynamic support after the unlocking and separation phase to restore vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has shown evidence of plaque stabilization and regression in the lesion.
“We are beyond thrilled with these findings from the BIOADAPTOR RCT,” said Motasim Sirhan, CEO of Elixir Medical. “Never before have we seen a vascular technology that addresses the limitations of existing revascularization therapies by restoring artery hemodynamic modulation and stabilizing or regressing plaque volume, as we have with DynamX bioadaptor. These exceptional patient clinical outcomes further validate that the bioadaptor is truly a transformative technology for coronary artery disease treatment.”
About BIOADAPTOR RCT Trial
The BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial (RCT) comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years.
BIOADAPTOR RCT trial is the third trial of Elixir Medical’s robust DynamX bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients.
About DynamX Coronary Bioadaptor System
The DynamX bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau between one-year and two-year clinical follow up.
The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S.
About Elixir Medical
Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at www.elixirmedical.com and on LinkedIn and X.
