Elixir Medical's DynamX BTK System Receives FDA Breakthrough Device Designation for CLTI Treatment

Mar 30, 2024 07:30 CST Updated 07:30

Elixir Medical

Medical Device R&D and Manufacturing Company

Chronic Limb-Threatening Ischemia (CLTI) is a clinical syndrome closely associated with high mortality, risk of amputation events, and decreased quality of life. The amputation rate for CLTI patients reaches up to 40% within 6 months, with nearly 50% being major limb amputations. Twenty-five percent of CLTI patients will die within 1 year, and 60% will die within 5 years.

The treatment of CLTI includes medication and revascularization. Medication involves the use of antithrombotic, lipid-lowering, antihypertensive, and glucose-regulating drugs, as well as lifestyle modifications such as smoking cessation, diet, exercise, and preventive foot care. According to a 2022 study by the American Heart Association (AHA), minimally invasive arterial opening procedures, whether through bypass surgery or stenting, can restore blood flow to the legs, thereby alleviating pain and improving the quality of life for patients with peripheral artery disease (PAD).

On March 21, 2024, Elixir Medical announced that its DynamX BTK system received the "Breakthrough Device" designation from the U.S. Food and Drug Administration (FDA). This is a novel adaptive implant designed to treat below-the-knee narrowed or blocked vessels in patients with chronic limb-threatening ischemia (CLTI).

The DynamX BTK system is designed to accommodate the physiological characteristics of blood vessels, thereby improving the limitations of traditional treatment methods. Six months after implantation, the polymer coating on the stent surface dissolves, allowing the stent structure to loosen while maintaining longitudinal continuity. This enables the stent to move freely with the natural expansion and contraction of the artery, preserving adaptive remodeling capabilities and restoring vascular physiological function while maintaining support.

Clinical Research Related to Coronary Artery Disease

In the BIOADAPTOR study, the DynamX BTK system was compared with traditional drug-eluting stents (DES). The results showed that the target lesion failure rate within 12 months was significantly lower in the DynamX BTK group than in the DES group. Additionally, the DynamX group was more effective in maintaining an open lumen. Moreover, the DynamX BTK system was able to restore arterial pulsatility after implantation and demonstrated a lower late lumen loss rate during long-term follow-up. The INFINITY-SWENEHEART study is a prospective, multicenter, single-blind, randomized clinical trial designed to evaluate the safety and efficacy of the DynamX Coronary Bioadaptor System compared to the Resolute Onyx DES. The primary endpoint was the target lesion failure rate at 12 months post-procedure, and the results indicated a significantly lower event rate in the DynamX treatment group compared to the DES group. To date, no clinical study results of DynamX in peripheral artery occlusion have been reported.

Approved Investigational Device Exemption (IDE)

On March 21, 2024, Elixir Medical announced that its DynamX BTK system had been granted Breakthrough Device Designation by the U.S. Food and Drug Administration. This adaptive implant is used to treat patients with chronic limb-threatening ischemia due to narrowing or blockage of vessels below the knee. The DynamX BTK system is an innovative treatment option designed to address issues associated with traditional drug-eluting stents and bioresorbable scaffolds while reducing the incidence of adverse clinical events. With further research, it has shown promising results in maintaining lumen gain, restoring vasomotion, and improving blood flow, addressing common problems with current BTK therapies. It is expected to bring new hope for the treatment of coronary artery and peripheral artery diseases.

Introduction to the DynamX BTK System

DynamX BTK System is a novel arterial stent developed by Elixir Medical Corporation, designed to treat infrapopliteal vascular stenosis or occlusion in patients with chronic limb disease. The DynamX BTK system aims to overcome the limitations of traditional drug-eluting stents (DES) and bioresorbable scaffolds (BRS), adapting to the physiological characteristics of blood vessels and providing support for the vessel during the first six months after implantation. After six months, the coating on its surface is absorbed by the body, allowing the stent structure to loosen while maintaining longitudinal continuity, enabling it to move freely with the natural expansion and contraction of the artery, offering an adaptive solution.

Elixir Medical Corporation

Elixir Medical Corporation is a medical device company located in California, USA, developing next-generation platforms for the treatment of coronary and peripheral artery diseases, aiming to restore vascular adaptive remodeling and pulsatile motion capabilities. The company's mission is to transform care for patients with heart and vascular diseases through innovation.

Reviewed and Edited by: Dr. Chen Xi, Associate Chief Physician, Wuhan First Hospital

Editor: Oliver, Vascular Information

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