WASHINGTON--(BUSINESS WIRE)--Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced late-breaking data demonstrating significant benefit of the DynamX® Coronary Bioadaptor System compared to contemporary Resolute Onyx™ zotarolimus drug-eluting stent (DES) for target lesion failure (TLF) in complex patient population subsets from the INFINITY-SWEDEHEART RCT. The data, which include an analysis of patients with acute coronary syndrome (ACS), small vessel lesions, and lesions within the left anterior descending (LAD) artery, were presented at Transcatheter Cardiovascular Therapeutics® (TCT®), the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®).
Additionally, the INFINITY-SWEDEHEART RCT data were published concurrently in The Lancet, in a peer-reviewed article entitled, “Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions – 12 months primary outcomes of the INFINITY-SWEDEHEART randomized non-inferiority trial.”
“Historically, patients with ACS are at a higher risk for adverse events after percutaneous coronary intervention (PCI) in part because of higher rates of comorbidities, reduced heart function, and more frail patient condition,” said David Erlinge, M.D., Ph.D., study principal investigator and head of the Cardiology Department at Lund University, Lund, Sweden. “Analysis of this critical population was key to understanding the effects of the bioadaptor’s unique mechanism of action on improving safety and effectiveness after PCI. With sustained reduction and plateauing of TLF after six months as compared to stents, the data further validate the substantial clinical benefit of bioadaptor and its potential to impact the treatment and long-term success in high-risk patient populations.”
After six months, clinical results in patients with ACS demonstrated:
- TLF of 0.3% versus 1.8% (p<0.018), translating into 83% reduction and significant benefit for DynamX bioadaptor compared to Resolute Onyx DES.
Additional analysis of clinically complex lesions associated with adverse DES outcomes, such as LAD artery and small vessels, demonstrate that bioadaptor’s unique mechanism of action translated into significant clinical improvement compared to DES, with INFINITY-SWEDEHEART results reinforcing the outcomes reported in the BIOADAPTOR-RCT trial.
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Patients with lesions in the LAD vessels demonstrated:
- 73% reduction (0.2% vs. 2.2%) in TLF rate after six months with DynamX bioadaptor compared to treatment with DES.
- There were no TLF events in patients with small vessels (less than or equal to 2.75 mm) in the DynamX bioadaptor arm compared to 1.8% TLF with DES after six months.
“Despite decades of innovation, drug-eluting stents and bioresorbable scaffolds continue to show a 2-3% non-plateauing adverse event rate increase per year, impacting 40-50% of patients within 10 years. The team at Elixir believed it was essential to restore vessel function in order to elevate coronary artery disease (CAD) treatment effectiveness and worked tirelessly to develop the bioadaptor to address this major challenge,” said Motasim Sirhan, CEO and founder of Elixir Medical. “We are thrilled that the results from INFINITY-SWEDEHEART and BIOADAPTOR-RCT trials validate the bioadaptor’s unique and novel mechanism of action to restore vessel function and manifest for the first time in PCI history the plateauing of adverse event rates six months after the procedure providing a better treatment option for patients with CAD.”
Unlike traditional PCI technologies, the bioadaptor leverages a unique mechanism of action that is designed to restore vessel motion and function by unlocking its helical strands after six months to provide adaptive, dynamic support to help the vessel better respond to the body’s physiological demands. Bioadaptor has been used to treat thousands of patients to date and has growing physician experience in complex PCI cases, including primary PCI, chronic total occlusions (CTOs), bifurcations, and calcified lesions.
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 device 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 providing plaque stabilization and regression. With this unique mechanism of action, 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 approved 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.
