Elixir’s DynamX Bioadaptor System Granted FDA Breakthrough Device Designation

June 18, 2024—Elixir Medical announced that the company’s DynamX sirolimus-eluting coronary bioadaptor system has been granted Breakthrough Device designation by the FDA. The designation is for an indication to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease caused by discrete de novo native coronary artery lesions.

The DynamX coronary bioadaptor system has received European CE Mark approval. It is not available for sale in the United States, advised the company.

According to Elixir, the DynamX bioadaptor’s mechanism of action is designed to return the diseased vessel to a more normal condition, through three distinct phases:

• First, after implantation, the locked phase establishes the maximum flow lumen and restores blood flow to treat symptoms of coronary artery disease.
• The second phase occurs after the bioadaptor is encapsulated with tissue and the absorbable polymer coating is resorbed. This enables the bioadaptor helical strands to unlock and separate, releasing and allowing the vessel to grow and adapt to maintain the established blood flow lumen.
• The third phase provides the vessel adaptive dynamic support by the separated helical strands. This restores the vessel viability and hemodynamic modulation by returning pulsatility, compliance, adaptive blood flow volume, and plaque stabilization and regression.

The BIOADAPTOR randomized controlled trial (RCT) is comparing the DynamX sirolimus-eluting coronary bioadaptor system to the standard-of-care Resolute Onyx zotarolimus drug-eluting stent (DES; Medtronic).

On May 20, Elixir Medical announced that 2-year results from the BIOADAPTOR RCT were presented at EuroPCR 2024, which was held May 14-17 in Paris, France.

Elixir stated that the late-breaking 2-year data demonstrated a statistically significant benefit of the DynamX versus the DES; in patients treated for de novo lesions (per protocol patient population analysis), there was a 65% reduction in target lesion failure (TLF) rate (1.9% vs 5.5%; P = .046). This reduction was driven by lower adverse events across all components of the composite endpoint for DynamX. In the critical left anterior descending artery vessels the effect was even more pronounced with a 78% reduction (1.9% vs 8.7%; P = .028) in the TLF rate with DynamX bioadaptor versus the DES.

The company also noted that the 12-month results from the BIOADAPTOR RCT showed superiority of DynamX versus the DES in imaging endpoints including lower percent-diameter stenosis, late lumen loss, and measures of vessel pulsatility, compliance, and adaptive blood flow by restoring hemodynamic modulation and vessel viability. The data were presented during a late-breaking clinical session at the EuroPCR 2023 conference held May 16-19 in Paris, France. In October 2023, Principal Investigator Shigeru Saito, MD, et al published the 12-month findings online in eClinicalMedicine.