Elixir Medical Wins Breakthrough Nod for DynamX Below-the-Knee System

Elixir Medical has been granted breakthrough device status from the U.S. Food and Drug Administration (FDA) for its DynamX BTK system, an adaptive implant to treat narrowed or blocked vessels below the knee (BTK) in patients with chronic limb-threatening ischemia (CLTI).
 
Without revascularization, CLTI may result in major amputation in a large number of patients.
 
The DynamX Bioadaptor platform aims to establish a new standard of care for vascular interventions. The company said it’s the only metallic device designed to support the vessel during healing, after which it unlocks and “uncages” the vessel while offering essential dynamic support, to restore vessel function and maintain an open lumen.
 
The technology has demonstrated high acute lumen gain in coronary vessels and maintenance of that gain over time, a common issue with current BTK therapies. The bioadaptor has also shown restoration of vessel motion and function, including positive adaptive remodeling, vessel pulsatility, improved vessel dynamic compliance, and blood flow volume increase.
 
“The Bioadaptor platform was developed to transform treatment of coronary and peripheral artery disease,” said Elixir Medical CEO Motasim Sirhan. “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.”