Data highlighted the success of DynamX compared to Medtronic’s Resolute Onyx zotarolimus drug-eluting stent (DES). The study looked at complex patient populations within the INFINITY-SWEDEHEART randomized controlled trial. Data included an analysis of patients with acute coronary syndrome (ACS), small vessel lesions, and lesions within the left anterior descending (LAD) artery.
INFINITY-SWEDEHEART compared the bioadaptor and DES at a 1:1 ratio in 2,400 patients. Investigators presented the findings at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C.
After six months, patients with ACS demonstrated TLF of 0.3% vs. 1.8% with DynamX vs. Resolute Onyx. That translated into an 83% reduction and significant benefit for the bioadaptor compared to the 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. INFINITY-SWEDEHEART results reinforced the outcomes reported in the BIOADAPTOR-RCT trial, Elixir said.
Patients with lesions in the LAD vessels demonstrated a 73% (0.2% vs. 2.2% with DES) reduction in TLF rate after six months with DynamX. No TLF events occurred in patients with small vessels with DynamX compared to 1.8% TLF with DES after six months.
“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,” said Motasim Sirhan, CEO and founder of Elixir Medical.
More about the Elixir DynamX bioadaptor
Elixir Medical’s sirolimus-eluting DynamX bioadaptor features a novel design and mechanism of action designed to return the diseased vessel to a more normal condition. It works in three distinct phases.
First, after implantation, the locked phase establishes the maximum flow lumen. That restores blood flow to treat symptoms of coronary artery disease (CAD). Unique to the bioadaptor, the second phase occurs after tissue encapsulates the device. This process resorbs the absorbable polymer coating and enables the helical strands to unlock and separate. That releases and allows the vessel to grow and adapt to maintain the established blood flow lumen.
The third phase provides the vessel adaptive dynamic support by the separated helical strands. This restores vessel viability and hemodynamic modulation by returning pulsatility, compliance, adaptive blood flow volume, and plaque stabilization and regression.
Elixir won FDA breakthrough device designation for DynamX earlier this year. The system has CE mark but remains investigational in the U.S.
“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,” Sirhan said. “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.”
