Elixir Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its DynamX Sirolimus-Eluting Coronary Bioadaptor System.
The designation is intended for the treatment of symptomatic ischemic heart disease caused by discrete de novo native coronary artery lesions, aiming to improve coronary luminal diameter and reduce plaque progression.
The DynamX bioadaptor is designed to restore the diseased vessel to a more natural condition through three different phases.
Initially, the bioadaptor's locked phase, following implantation, establishes the maximum flow lumen. Later, the bioadaptor is encapsulated with tissue and its absorbable polymer coating is resorbed, allowing the helical strands to unlock and separate.
This mechanism enables the vessel to grow and adapt to maintain blood flow. The final phase provides dynamic support, restoring vessel viability and hemodynamic modulation.
Elixir Medical CEO Motasim Sirhan said: “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.”
Recent two-year results from the BIOADAPTOR Randomised Controlled Trial have shown a significant benefit of the DynamX bioadaptor over the standard of care.
Patients treated with DynamX for de novo lesions experienced a 65% reduction in Target Lesion Failure (TLF) rate compared with those treated with the Resolute Onyx Drug-Eluting Stent (DES).
This reduction was driven by lower adverse events in all composite endpoint components for DynamX.
Furthermore, in critical left anterior descending artery vessels, the DynamX bioadaptor demonstrated a 78% reduction in the TLF rate compared to DES.
These findings build upon 12-month results that indicated superiority over DES in imaging endpoints, including lower percentage diameter stenosis and late lumen loss, as well as new measures of vessel pulsatility, compliance and adaptive blood flow.
In March 2024, the FDA granted breakthrough device designation to Elixir Medical’s DynamX BTK System.
