Oct. 28, 2024 – Elixir Medical 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.
- 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.
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.
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