EuroPCR 2024: Elixir Medical's DynamX Bioadaptor Outperforms Standard Drug-Eluting Stent at Two Years

Elixir Medical, a company focused on developing innovative solutions for cardiovascular and peripheral diseases, has announced promising two-year results from the BIOADAPTOR Randomized Controlled Trial (RCT). The trial compares the DynamX® Coronary Bioadaptor System to the standard Resolute OnyxTM Drug-Eluting Stent (DES) across 34 centers in Japan, Europe, and New Zealand. These findings, presented at the EuroPCR 2024 conference in Paris, highlight a significant reduction in adverse events and clinical benefits associated with the DynamX bioadaptor.

The clinical trial data reveal that DynamX bioadaptor offers a substantial reduction in target lesion failure (TLF) and target vessel failure (TVF) compared to DES. Specifically, the TLF rate for DynamX was reduced by 65% (1.9% vs. 5.5%; p=0.046), driven by lower adverse events in all components of the composite endpoint. The results showed no cardiovascular deaths in the DynamX group compared to 1.8% in the DES group. Additionally, the rates of target vessel myocardial infarction and target lesion revascularization were lower in the DynamX group (0.9% vs. 1.9% and 0.9% vs. 2.3%, respectively).

Similarly, DynamX demonstrated a 68% reduction in TVF rate (1.9% vs. 6.0%; p=0.029) compared to DES, emphasizing its clinical advantage. When focusing on specific lesion subsets, the DynamX bioadaptor showed even more impressive outcomes. In the left anterior descending (LAD) artery, DynamX achieved a 78% reduction in TLF (1.9% vs. 8.7%; p=0.028). For smaller vessels (less than 2.75mm), the TLF rate was 0% in the DynamX group compared to 3.5% in the DES group. For longer lesions (greater than 23mm), the TLF rate was again 0% in the DynamX group versus 2.3% in the DES group.

Dr. Shigeru Saito, director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan, highlighted the importance of these findings. He emphasized that the two-year results confirm the bioadaptor’s novel design and mechanism, which help restore vessel viability and hemodynamic modulation. The data suggest that DynamX offers sustained low event rates across major endpoints, making it a preferable alternative to DES.

The DynamX bioadaptor stands out from current therapies due to its unique mechanism of action. It operates through three adaptive phases within the body to restore vessel biology. Initially, the locked phase ensures maximum lumen flow and restores blood circulation. The unlocked and separation phase then releases the vessel while maintaining the flow lumen. Finally, the adaptive dynamic support phase restores vessel hemodynamic modulation, demonstrated by the return of pulsatility and adaptive blood flow volume, and shows evidence of plaque stabilization and regression in the lesion.

Motasim Sirhan, CEO of Elixir Medical, expressed his enthusiasm for the BIOADAPTOR RCT findings. He noted that the results validate the bioadaptor's transformative impact on coronary artery disease treatment by addressing current revascularization therapy limitations and achieving exceptional patient outcomes.

The BIOADAPTOR RCT is an international, single-blind, randomized controlled trial involving 445 patients. It compares a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent, including large subgroups undergoing multi-modality imaging to document effectiveness benchmarks. Clinical follow-up for the trial will continue for five years.

Elixir Medical's robust clinical evidence program for the DynamX bioadaptor consists of nine studies involving over 9,000 patients. This includes the INFINITY SWEDEHEART RCT and a global BIO-RESTORE registry aiming to enroll up to 5,000 patients.

The DynamX Coronary Bioadaptor System is CE-marked and represents a significant advancement in coronary implant technology. It is designed to restore coronary artery hemodynamic modulation, addressing the limitations of existing drug-eluting stents and bioresorbable scaffolds.