US-based medical technology company Elixir Medical has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for its DynamX BTK System.
DynamX is a novel, adaptive implant intended for use in the treatment of narrowed or blocked vessels below the knee (BTK) in patients with chronic limb-threatening ischemia (CLTI).
The system leverages the DynamX Bioadaptor platform, a medical technology designed to uncage the vessel and restore normal vessel motion and function after PCI or BTK intervention.
With a unique mechanism of action (MOA), the technology maintains dynamic support of the diseased vessel after uncaging, establishing a new standard of care for vascular interventions.
Elixir Medical CEO Motasim Sirhan said: “The Bioadaptor platform was developed to transform 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.”
Peripheral arterial disease (PAD) is a condition characterised by narrowing or blockage of the blood vessels in the leg, primarily caused by the buildup of fatty plaque in the arteries.
CLTI is an advanced stage of PAD and is associated with risk to both life and limb, with one-year estimates of mortality over 20% across a range of observational studies.
According to Elixir, DynamX is the only metallic device designed to support the vessel during the healing phase, after which it unlocks the vessel.
The system also provides essential dynamic support to restore vessel function and maintain an open lumen.
The unique design and mechanism of action make bioadaptor a promising therapy in BTK revascularisation, said the medical device maker.
DynamX Bioadaptor provides high acute lumen gain in the coronary vessels and maintains the gain over time, which is a common challenge in existing BTK therapies.
The bioadaptor also restores vessel motion and function, including positive adaptive remodelling, vessel pulsatility, improved vessel dynamic compliance, and enhanced blood flow.
