Friday, March 22, 2024
Elixir Medical has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System. This designation signifies a significant advancement in the treatment of cardiovascular and peripheral diseases. The DynamX BTK System is specifically developed to address narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI).
At the core of the DynamX BTK System is the innovative DynamX Bioadaptor platform. This platform aims to set a new standard in vascular interventions by providing dynamic support to vessels during the healing phase. Unlike conventional metallic devices, the DynamX Bioadaptor adapts to unlock and restore vessel function, maintaining an open lumen.
The unique design and mechanism of the Bioadaptor hold promise for BTK revascularization, tackling challenges encountered with existing therapies. Clinical studies have demonstrated its ability to achieve high acute lumen gain, restore vessel motion and function, promote positive adaptive remodeling, improve vessel dynamic compliance, and increase blood flow volume.
Given the global prevalence of peripheral arterial disease (PAD), particularly its severe form, CLTI, the DynamX Bioadaptor platform could have a significant impact on patient outcomes worldwide. The FDA's Breakthrough Device Designation expedites the review process, indicating that the DynamX BTK System meets stringent standards for safety and effectiveness.
Overall, Elixir Medical's DynamX Bioadaptor platform represents a promising advancement in the treatment landscape for cardiovascular and peripheral diseases, offering hope for improved outcomes and quality of life for patients with CLTI.
Source: businesswire.com
