Elixir Medical has announced that its DynamX® BTK System has received FDA Breakthrough Device Designation. This system is an adaptive implant developed for treating narrowed or blocked vessels below the knee (BTK) in patients suffering from chronic limb-threatening ischemia (CLTI). Part of the DynamX Bioadaptor platform, it aims to establish a new standard of care in vascular interventions by providing dynamic support to vessels during the healing process. Afterward, it uncages the vessel to restore function.
CLTI, a severe manifestation of peripheral arterial disease (PAD), poses significant risks to both life and limb, with mortality rates exceeding 20% in various studies. Without effective revascularization, CLTI often leads to major amputations. The DynamX Bioadaptor offers a promising solution in BTK revascularization due to its unique design and mechanism of action.
The Bioadaptor has demonstrated its ability to provide substantial lumen gain in coronary vessels and maintain it over time, addressing a common challenge in existing BTK therapies. Furthermore, it restores vessel motion and function, promoting positive adaptive remodeling, vessel pulsatility, improved vessel dynamic compliance, and increased blood flow volume.
The DynamX Bioadaptor platform was developed to revolutionize the treatment of coronary and peripheral artery disease. The FDA Breakthrough Device Designation expedites the review process for innovative technologies that address unmet medical needs. As the first implant technology of its kind, the Bioadaptor aims to unlock vessels, restore normal motion and function, and sustain dynamic support following percutaneous coronary intervention (PCI) or BTK intervention, setting a new standard of care in vascular intervention.
Source: https://www.businesswire.com/news/home/20240321347250/en/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
