Elixir Medical’s DynamX Sirolimus Secures FDA Breakthrough Device Approval for Symptomatic Heart Disease

Elixir Medical announced the novel bioadaptive implant, DynamX® Sirolimus-Eluting Coronary Bioadaptor System, granted Breakthrough Device by the U.S. Food and Drug Administration (FDA). 

The breakthrough designation is used to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions.

The DynamX bioadaptor features an innovative design and mechanism used for restoring diseased vessels to a more natural state through three distinct phases-

• After implantation, the initial locked phase establishes the maximum lumen size, effectively restoring blood flow to alleviate symptoms of coronary artery disease (CAD).
• The second phase, which occurs once the device is encapsulated by tissue and the absorbable polymer coating has been resorbed. This process allows the bioadaptor’s helical strands to unlock and separate, facilitating vessel growth and adaptation while maintaining the established blood flow lumen.
• The third and most distinctive phase offers dynamic support to the vessel through the separated helical strands. This phase enhances vessel viability and hemodynamic function by reintroducing pulsatility, improving compliance, adjusting blood flow volume, and promoting plaque stabilization and regression.

The DynamX bioadaptor is the first coronary implant technology developed to restore hemodynamic modulation in coronary arteries. It achieves this by enhancing vessel pulsatility, improving compliance, allowing for an adaptive increase in blood flow volume, and promoting both plaque stabilization and regression.

Source: https://elixirmedical.com/elixir-medicals-dynamx-sirolimus-eluting-coronary-bioadaptor-system-granted-fda-breakthrough-device-designation-for-the-treatment-of-symptomatic-ischemic-heart-disease/