Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System

Elixir Medical has been granted Breakthrough Device Designation by the US FDA for its DynamX® BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI).

The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions. It is the only metallic device designed to support the vessel during the healing phase, after which it unlocks and “uncages” the vessel while providing the essential dynamic support, to restore vessel function and maintain an open lumen.

Because of its unique design and mechanism of action, the bioadaptor is a promising therapy in BTK revascularization. The DynamX Bioadaptor has been shown to provide high acute lumen gain in the coronary vessels and maintain such gain over time, which is a common challenge in existing BTK therapies. The bioadaptor has also been shown to restore vessel motion and function, including positive adaptive remodeling, vessel pulsatility, improved vessel dynamic compliance, and an increase in blood flow volume.

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,” said Motasim Sirhan, CEO at Elixir Medical.

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