The US Food and Drug Administration (FDA) has granted breakthrough device designation to Elixir Medical’s DynamX BTK System.
The adaptive implant is designed for the treatment of narrowed or blocked vessels below the knee (BTK) in individuals with chronic limb-threatening ischemia (CLTI), a severe condition that can lead to amputation if left untreated.
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Elixir’s DynamX BTK System broadens the application of its bioadaptor platform technology, which was initially developed for coronary artery disease.
The DynamX Bioadaptor platform represents a significant advancement in vascular interventions, potentially setting a new standard of care.
This platform is a metallic device that supports the healing vessel and then ‘uncages’ to allow for vessel movement and function, aiming to maintain an open lumen and improve blood flow.
Clinical data has demonstrated that the DynamX Bioadaptor can restore vessel motion and function, including increased blood flow volume and positive adaptive remodelling.
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By GlobalDataElixir Medical CEO Motasim Sirhan said: “The Bioadaptor platform was developed to transform the treatment of coronary and peripheral artery disease.
“We appreciate the FDA recognition of our innovation for treating the CLTI population with BTK disease and its potential impact on the patients suffering from vascular disease.”
Currently, the DynamX BTK System is not available for sale in the US, but the FDA’s breakthrough device designation could expedite its development and review process.
In July 2023, Elixir Medical said the final patient was enrolled in a study comparing its metallic coronary artery implant to Resolute Onyx’s drug-eluting stent (DES).
The multicentre, prospective, single-blind, randomised registry-based trial enrolled 2,400 patients with ischemic heart disease across Sweden with a primary endpoint of target lesion failure at a one-year follow-up.
