Elixir Medical announced positive data from the INFINITY-SWEDEHEART randomized controlled trial, showcasing the benefits of its DynamX coronary bioadaptor system in reducing target lesion failure (TLF) compared to Medtronic’s Resolute Onyx zotarolimus drug-eluting stent (DES). The findings, presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024, highlight the potential of DynamX in treating complex patient populations with acute coronary syndrome (ACS), small vessel lesions, and lesions within the left anterior descending (LAD) artery.
Superior Outcomes in Acute Coronary Syndrome
The INFINITY-SWEDEHEART trial compared the DynamX bioadaptor and the Resolute Onyx DES in a 1:1 ratio across 2,400 patients. After six months, patients with ACS treated with DynamX showed a TLF rate of 0.3%, compared to 1.8% in those treated with Resolute Onyx. This represents an 83% reduction in TLF, indicating a significant benefit for the bioadaptor in this patient group.
Benefits in Complex Lesions
Further analysis focused on clinically complex lesions often associated with adverse DES outcomes. Patients with lesions in the LAD vessels treated with DynamX experienced a 73% reduction in TLF rate (0.2% vs. 2.2% with DES) after six months. Notably, no TLF events occurred in patients with small vessels treated with DynamX, compared to a 1.8% TLF rate with DES after six months. These results suggest that the bioadaptor's mechanism of action provides significant clinical improvement in challenging lesion types.
DynamX Bioadaptor: Restoring Vessel Function
The DynamX sirolimus-eluting bioadaptor features a novel design aimed at restoring diseased vessels to a more normal condition. It operates in three distinct phases:
- Locked Phase: Immediately post-implantation, the device establishes maximum flow lumen, restoring blood flow and alleviating symptoms of coronary artery disease (CAD).
- Unlocking Phase: After tissue encapsulation, the absorbable polymer coating resorbs, allowing the helical strands to unlock and separate. This enables the vessel to grow and adapt while maintaining the established blood flow lumen.
- Adaptive Support Phase: The separated helical strands provide dynamic support to the vessel, restoring viability and hemodynamic modulation by returning pulsatility, compliance, adaptive blood flow volume, and plaque stabilization and regression.
Addressing Unmet Needs in CAD Treatment
According to Motasim Sirhan, CEO and founder of Elixir Medical, conventional drug-eluting stents and bioresorbable scaffolds exhibit a 2-3% non-plateauing adverse event rate increase per year, potentially affecting 40-50% of patients within 10 years. The DynamX bioadaptor aims to address this challenge by restoring vessel function and improving the effectiveness of CAD treatment.
The FDA granted breakthrough device designation to DynamX earlier this year. While the system has CE mark, it remains investigational in the U.S.
