Elixir Medical gets FDA breakthrough device designation for DynamX BTK

Elixir Medical announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI).

The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions. It is the only metallic device designed to support the vessel during the healing phase, after which it unlocks and “uncages” the vessel while providing the essential dynamic support, to restore vessel function and maintain an open lumen.

Peripheral arterial disease (PAD) affects more than 200 million people worldwide.1,2 Its most severe form is CLTI, which represents an advanced stage of PAD with risk to both life and limb, and one-year estimates of mortality over 20% across a range of observational studies.3 Without revascularization, CLTI results in major amputation in a large number of patients.5,6,7

Because of its unique design and mechanism of action, the bioadaptor is a promising therapy in BTK revascularization. The DynamX Bioadaptor has been shown to provide high acute lumen gain in the coronary vessels and maintain such gain over time, which is a common challenge in existing BTK therapies. The bioadaptor has also been shown to restore vessel motion and function, including positive adaptive remodeling, vessel pulsatility, improved vessel dynamic compliance, and an increase in blood flow volume.

“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.
MB Bureau