Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease
The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions.
- The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions.
- "The Bioadaptor platform was developed to transform treatment of coronary and peripheral artery disease,” said Motasim Sirhan, CEO at Elixir Medical.
- “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.”
The FDA Breakthrough Device Designation accelerates the review process for novel technologies designed to address an unmet medical need. - Devices that receive breakthrough designation must meet rigorous standards for device safety and effectiveness in order to be authorized for marketing.