Elixir Medical's DynamX Coronary Bioadaptor Receives FDA Breakthrough Device Designation

Elixir Medical Corporation announced that its novel bio-adaptive implant, the DynamX Sirolimus-Eluting Coronary Bioadaptor System, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation recognizes the novelty of the technology and its potential to offer more effective treatment options for patients with coronary artery disease.

Recently, Elixir Medical announced that its novel bio-adaptive implant, the DynamX Sirolimus-Eluting Coronary Bioadaptor System, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This breakthrough device is indicated for improving coronary lumen diameter, restoring hemodynamics, and reducing plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo spontaneous coronary artery lesions.

DynamX Bioadaptor Implant features a novel design and mechanism of action, aiming to restore diseased vessels to a more normal state through three distinct phases. Immediately after implantation, the Locked Phase establishes maximum lumen and restores blood flow to treat symptoms of coronary artery disease (CAD). What makes the bioadaptor unique is that the second phase occurs after the Bioadaptor is encapsulated by tissue and the bioresorbable polymer coating is resorbed. This allows the Bioadaptor’s helical struts to unlock and separate, releasing and enabling vessel growth and adaptation to maintain the established blood flow lumen. The third and most distinctive phase provides adaptive dynamic support to the vessel via the separated helical struts. This restores vascular vitality and hemodynamic regulation by reinstating pulsatility, compliance, adaptive blood flow, as well as plaque stabilization and regression.

FDA Breakthrough Device Designation accelerates the review process for new technologies that may offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions, such as CAD, which affects 7.8% of the U.S. population.¹

To date, the use of drug-eluting stents for interventional treatment of coronary artery disease has been able to establish blood flow through angiography. However, up to 20% of patients will experience implant-related repeat adverse events within five years after treatment.²For years, the use of stents was considered the primary driver of the annual increase in non-platform event rates. However, data from the "leave no trace" approach using bioresorbable stent technology shows that non-platform event rates continue to occur even after stent resorption. Therefore, we need a more innovative approach to restore vascular vitality.³

Latest Two-Year BIOADAPTOR RCT Data Presented at EuroPCR 2024⁴Compared with the standard-of-care Resolute Onyx drug-eluting stent (DES), the DynamX Bioadaptor demonstrated statistically significant benefits, with a 65% reduction in TLF rates (1.9% vs. 5.5%; p=0.046) in patients treated for de novo lesions (according to the per-protocol patient population analysis). This reduction was driven by decreases in adverse events across all components of the DynamX composite endpoint. In the critical left anterior descending (LAD) artery, the effect was even more pronounced, with the TLF rate for the DynamX Bioadaptor reduced by 78% compared to DES (1.9% vs. 8.7%; p=0.028). These data follow 12-month outcomes showing superiority over DES in imaging endpoints, including lower percentage diameter stenosis, less late lumen loss, and new measures of vascular pulsatility, compliance, and adaptive flow through the restoration of hemodynamic modulation and vessel vitality.⁵

DynamX Bioadaptor is the first coronary implant technology,Aimed at restoring coronary artery hemodynamic regulation, manifested by the restoration of vascular pulsation, compliance, adaptive increase in blood flow, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds, showing a very low rate of clinical events, with clinical follow-up stabilizing between one and two years.

Elixir Medical Corporation is a medical technology company headquartered in Milpitas, California, developing disruptive platforms for the treatment of coronary and peripheral artery diseases, including DynamX BTK, LithiX Hertz Contact IVL, and TRx site-specific antithrombotic therapy. The DynamX Coronary Bioadaptor System has received CE Mark approval.

References:

1 https://www.ahajournals.org/doi/10.1161/CIR.0000000000001256

2 Madhavan MV, et al. Stent Related Adverse Events greater than 1 Year After PCI. JACC 2020.

3 https://www.jacc.org/doi/10.1016/j.jacc.2023.05.003

4 Saito S, M.D. Presented at EuroPCR 2024.

5 Saito S, et al. BIOADAPTOR RCT 12-month clinical and imaging data. eClinicalMedicine Lancet 2023.

This Issue's Planning: Shen Li

Editor-in-Chief: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production:Ling Wujuan