Elixir Medical has announced that its novel bioadaptive implant, the DynamX sirolimus-eluting coronary bioadaptor system, has been granted breakthrough device designation by the US Food and Drug Administration (FDA).
The breakthrough designation is for an indication to improve coronary luminal diameter, restore haemodynamic modulation, and reduce plaque progression in patients with symptomatic ischaemic heart disease due to discrete de novo native coronary artery lesions.
The DynamX bioadaptor has a novel design and mechanism of action designed to return the diseased vessel to a more normal condition, through three distinct phases. After implantation, the locked phase establishes the maximum flow lumen and restores blood flow to treat symptoms of coronary artery disease (CAD).
Unique to the bioadaptor, the second phase occurs after the bioadaptor is encapsulated with tissue and the absorbable polymer coating is resorbed. This enables the bioadaptor helical strands to unlock and separate, releasing and allowing the vessel to grow and adapt to maintain the established blood flow lumen.
The third and most unique phase provides the vessel adaptive dynamic support by the separated helical strands. This restores the vessel viability and hemodynamic modulation by returning pulsatility, compliance, adaptive blood flow volume, and plaque stabilization and regression.
FDA breakthrough device designation accelerates the review process for novel technologies that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as CAD, which impacts 7.8% of the US population.
To date, interventional treatment of coronary artery disease with drug-eluting stents has been able to establish flow angiographically. However, up to 20% of patients experience a repeat adverse event related to the implant within five years of treatment.
“For many years, it was thought that caging of the vessel with stents was the main driver for annual increasing non-plateauing event rates. However, the data with the ‘leave nothing behind’ approach with bioresorbable scaffold technologies, showed non-plateauing event rates continue to occur even after resorption of the scaffold, so we needed a more innovative approach to restore vessel viability,” said Motasim Sirhan, CEO of Elixir Medical.
“We very much appreciate FDA’s breakthrough designation recognition of the bioadaptor technology,” continued Sirhan. “We look forward to working with FDA, Centers for Medicare & Medicaid Services, and respective physician societies to bring this technology to US patients as soon as possible to elevate the standard of care for cardiovascular disease treatment.”
Late-breaking two-year BIOADAPTOR RCT data presented at EuroPCR 2024 (14–17 May, Paris, France) demonstrated a statistically significant benefit of DynamX bioadaptor over the standard of care, Resolute Onyx drug-eluting stent (DES, Medtronic), where in patients treated for de novo lesions (per protocol patient population analysis), there was a 65% reduction in TLF rate (1.9% versus 5.5%; p=0.046) respectively.
