Elixir Medical has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for the DynamX Sirolimus-Eluting Coronary Bioadaptor System.
The DynamX bioadaptor is a bioadaptive implant technology designed for patients with coronary artery disease (CAD).
The FDA breakthrough status is for an indication to enhance coronary luminal diameter, restore haemodynamic modulation, and lower plaque progression in individuals with symptomatic ischemic heart disease.
The device has already received CE mark approval in Europe.
According to Elixir Medical, the DynamX bioadaptor has a new design and action mechanism aimed at restoring diseased vessels to a healthier state through three distinct phases.
Following implantation, the initial locked phase establishes the maximum flow lumen, effectively restoring blood flow to alleviate symptoms associated with CAD.
In the second phase, the device is enveloped by tissue and its absorbable polymer coating is resorbed.
During this phase, the bioadaptor’s helical strands unlock and separate, supporting the release and subsequent adaptation of the vessel to maintain the established blood flow lumen.
The third phase involves ongoing support from these separated helical strands, offering adaptive dynamic support to the vessel, according to Elixir Medical.
In addition, this restores vessel viability and modulates haemodynamics by reintroducing pulsatility, compliance, adaptive blood flow volume, and stabilisation and regression of plaque.
Elixir Medical CEO Motasim Sirhan said: “We very much appreciate FDA’s breakthrough designation recognition of the bioadaptor technology.
“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.”
The California-based medical technology firm said that the DynamX Sirolimus-Eluting Coronary Bioadaptor System showed a statistically significant benefit over the standard of care, Medtronic’s Resolute Onyx drug-eluting stent.
The late-breaking two-year BIOADAPTOR RCT data was presented at EuroPCR 2024.
Elixir Medical is engaged in developing platforms aimed at treating coronary and peripheral artery disease.
Its offerings include DynamX BTK, LithiX Hertz Contact IVL, and TRx site-specific antithrombotic therapy.
In March, the company received the FDA breakthrough status for DynamX BTK to treat narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI).
