ESC Congress 2024: INFINITY-SWEDEHEART Trial of Elixir Medical’s DynamX Bioadaptor Meets Primary Endpoint and Clinical Results Confirm Unique Mechanism of Action

—Largest randomized data set to date on bioadaptor, with a complex patient population of 2,400 compared to a DES—

—Primary endpoint of target lesion failure (TLF) non-inferiority at twelve months was met with a low event rate for DynamX despite increased patient complexity—

—Pre-specified landmark analysis shows statistically significant reduction in TLF and target vessel failure (TVF) after six months—

Elixir Medical News

LONDON--Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, announced the INFINITY-SWEDEHEART Randomized Controlled Trial (RCT) comparing the novel DynamX® Coronary Bioadaptor System with the contemporary Resolute Onyx™ zotarolimus drug-eluting stent (DES) met its primary endpoint of target lesion failure (TLF) non-inferiority (2.35% versus 2.77%; p<0.001) at 12 months. The data were presented as a late-breaking Hot Line session at the European Society of Cardiology (ESC) Congress 2024 in London.

“The DynamX bioadaptor represents a significant clinical advancement in the treatment of coronary artery disease with a unique mechanism of action six months following the percutaneous coronary intervention (PCI) procedure,” said principal investigator David Erlinge, M.D., Ph.D., and head of the Cardiology Department at Lund University, Lund, Sweden. “Each year millions of patients undergo PCI globally, and while a very safe procedure, the implantation of stents has been associated with an annual recurring adverse event rate. Sustained reduction and plateauing of these recurring adverse clinical events would create a major benefit over the lifetime of a patient.”

Clinical results from the 2,400-patient INFINITY-SWEDEHEART study demonstrated:

• TLF of 2.35% versus 2.77% met non-inferiority (p<0.001) at 12 months for DynamX bioadaptor and Resolute Onyx DES, respectively. The low TLF with DynamX was driven by numerically low adverse events across components of the composite endpoint with DynamX compared to Resolute Onyx DES, respectively:
  • Target vessel myocardial infarction (TV-MI) (1.27% versus 1.52%)
     
  • Ischemia-driven target lesion revascularization (ID-TLR) (1.27% versus 2.11%)
     
  • Cardiovascular death (0.59% versus 0.50%)
     
• Target vessel failure (TVF) at 12 months was also lower at 3.03% versus 3.52%, for DynamX compared to DES, respectively.

Landmark analysis¹:

Pre-specified landmark analyses of TLF and TVF after six months demonstrated:

• Statistically significant reduction in TLF with DynamX (0.2% versus 1.3%, p=0.003)
   
• Statistically significant reduction in TVF with DynamX (0.6% versus 1.8%, p=0.008)
   
• These event rates were driven by reduction across all components of these composite endpoints

“The results of our trial strongly support the clinical impact of the Bioadaptor in coronary artery disease treatment, with a potential to significantly reduce the recurring adverse event risk after percutaneous coronary intervention in a population representative of everyday clinical practice,” said study chair Stefan James, M.D., Ph.D., and Professor of Cardiology at Uppsala University, Sweden. “The Bioadaptor technology has proven to be able to do this through its unique design and mechanism of action of restoring hemodynamic modulation of a diseased artery.

The DynamX bioadaptor was recently granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for an indication to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The bioadaptor has a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore more normal vessel biology.

• Locked phase: The bioadaptor establishes maximum flow lumen to restore blood flow.
   
• Unlocked/Separation phase: Unique to the bioadaptor, after six months, helical strands unlock and separate to allow adaptive remodeling of the vessel to maintain the established blood flow lumen.
   
• Adaptive dynamic support phase: The three—now independent—helical strands continue to provide essential support as the bioadaptor re-establishes vessel hemodynamic modulation through restoration of pulsatility, compliance and adaptive blood flow volume.

“Results from the INFINITY-SWEDEHEART trial validate in a broad, more clinically complex patient population what we’ve shown previously in BIOADAPTOR RCT and several mechanistic and investigator-initiated studies – consistency of low and plateauing adverse event rates after the unlocking of the bioadaptor at six months,” said Motasim Sirhan, CEO of Elixir Medical. “We are thrilled by the results from the landmark analysis data after six months showing statistically significant reduction in TLF and TVF versus DES. As an innovation-driven company, these data further validate the bioadaptor’s unique mechanism of action and its advantage in treating coronary artery disease to improve the standard of care for our patients.”

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. 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.

DynamX Coronary Bioadaptor System

The DynamX bioadaptor is designated by the 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), the bioadaptor addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds translating to remarkably low clinical event rates that plateau after six months as demonstrated in two randomized controlled trials, BIOADAPTOR-RCT (N=445) and INFINITY-SWEDEHEART (N=2,400).

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.

Reference
1 Erlinge, D., Andersson, J., Fröbert, O., Törnerud, M., Böhm, F., Held, C., Elek, C., Sirhan, M., Oldgren, J., & James, S. (2024). Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent. American Heart Journal, 277, 1-10. https://doi.org/10.1016/j.ahj.2024.07.016

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