US FDA Breakthrough Device designation granted for DynamX BTK for use in CLTI treatment below the knee

Elixir Medical’s DynamX

Elixir Medical has announced Breakthrough Device designation by the US Food and Drug Administration (FDA) for its novel DynamX BTK System, an implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischaemia (CLTI).

The DynamX bioadaptor platform is a metallic device designed to support vessels during the healing phase, after which it unlocks and “uncages” them while providing dynamic support to restore function and maintain an open lumen, according to a company press release. The DynamX BTK System for the treatment of BTK vessels impacted by CLTI broadens the use of the technology beyond the treatment of coronary artery disease, the press release stated.

“The bioadaptor platform was developed to transform treatment of coronary and peripheral artery disease [PAD],” said Motasim Sirhan, Elixir Medical CEO. “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 DynamX BTK System is not available for sale in the USA.


Please enter your comment!
Please enter your name here