Elixir Medical Releases Positive Data on its DynamX Bioadaptor

Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, announced late-breaking data demonstrating a significant benefit of the DynamX Coronary Bioadaptor System compared to contemporary Resolute OnyxTM zotarolimus drug-eluting stent (DES) for target lesion failure (TLF) in complex patient population subsets from the Infinity-Swedeheart RCT. 

“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.”

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 by restoring vessel pulsatility, compliance, adaptive increase in blood flow volume, and providing plaque stabilization and regression. 

The bioadaptor addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds. This results in low clinical event rates that plateau after six months, which has been demonstrated in two randomized controlled trials, Bioadaptor-RCT (N=445) and Infinity-Swedeheart (N=2,400).

The Infinity-Swedeheart Trial was 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 was conducted 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.

Key Results After Six-Months with ACS Include

• 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.
• Patients with lesions in the LAD vessels showed a 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.

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.

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. 

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.”

The data, which included 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).