Twelve-month primary and secondary endpoints data compare DynamX Coronary Bioadaptor System with a contemporary drug-eluting stent (DES) in a broad patient population
Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced it will present one-year clinical outcomes from the 2,400 patient INFINITY-SWEDEHEART Randomized Clinical Trial (RCT), a prospective, multi-center, single-blind, clinical trial comparing the drug-eluting DynamX Coronary Bioadaptor System with the contemporary Resolute OnyxTM zotarolimus drug-eluting stent (DES), at a late-breaking Hot Line session at ESC Congress 2024 in London.
"Today's minimally invasive coronary artery disease (CAD) treatments are limited to only establishing a fixed flow lumen in the artery which re-narrows over time presenting an unacceptable major adverse event rate (MACE) of 20% by five years1 and up to 50% by 10 years2, increasing annually without a plateau3. The DynamX bioadaptor was developed to address and surpass the limitations of CAD treatments by not only being capable of establishing a flow lumen, but also uniquely restoring the essential attributes of vessel function to adapt and maintain the established flow lumen, restore hemodynamic modulation of the artery, and reduce plaque progression to deliver a sustained, low adverse event rate that plateaus after six months," said Motasim Sirhan, CEO of Elixir Medical. "Building on the exceptional results of the BIOADAPTOR-RCT study, where we observed a statistically significant 65% reduction in clinical events in de novo lesions by two years compared to Resolute Onyx DES4, the INFINITY-SWEDEHEART RCT will provide evidence of the DynamX bioadaptor performance in a broader, real-world patient population, including a large cohort of patients with acute coronary syndrome (ACS)."
The INFINITY-SWEDEHEART RCT enrolled 2,400 patients from 20 sites in Sweden. The trial is executed through the SWEDEHEART registry program in Sweden, a national collaborative research program supporting the evidence-based development of therapies for heart disease. Study management is conducted in collaboration with Uppsala Clinical Research Center (UCR), a non-profit organization providing clinical research services for the development and improvement of health care in Sweden and worldwide.
The data will be presented by David Erlinge, M.D., Ph.D., head of the Cardiology Department at Skane University Hospital, Lund, SE, in the Hot Line session "INFINITY-SWEDEHEART Percutaneous coronary intervention with a bioadaptor compared to a contemporary drug-eluting stent one-year primary outcomes." The presentation will also include a discussant review and panel discussion.
Presentation details: HOT LINE 11
Title: "INFINITY-SWEDEHEART Percutaneous coronary intervention with a bioadaptor compared to a contemporary drug eluting stent- one-year primary outcomes"
Principal investigator: David Erlinge, M.D., Ph.D., head of the Cardiology Department at Skane University Hospital, Lund, SE.
Date: Monday, September 2, 2024
Time: 13:45 14:45 BST
Location: Main Auditorium
About the INFINITY-SWEDEHEART Trial
The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. The trial is executed in partnership with the ongoing SWEDEHEART registry program in Sweden, a national collaborative research program launched in 2009 to support the evidence-based development of therapies for heart disease.
DynamX Coronary Bioadaptor System
The DynamX bioadaptor is designated by the U.S. Food and Drug Administration (FDA) as a breakthrough technology and is the first coronary implant designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, adaptive increase in blood flow volume, and to provide plaque stabilization and regression. With this unique mechanism of action (MOA), bioadaptor addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds, translating to remarkably low clinical event rates that showed a plateau between one-year and two-year clinical follow-up in the BIOADAPTOR RCT study.
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 transformative 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.
References:
1. Iqbal et al. Final 5-Year Report of the RESOLUTE All-comers Trial. Circ Cardiovasc Interv. 2015.
2. Kufner et al. ISAR-TEST 4 Trial. Circulation, 2019.
3. Madhavan MV et al. J Am Coll Cardiol 2020;75:590-604
4. Saito S. Two-year clinical outcomes of the BIOADAPTOR RCT study. EuroPCR 2024.
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