Elixir DynamX Bioadaptor Evaluated in ACS and Complex Lesion Subsets From INFINITY-SWEDEHEART

October 28, 2024—Elixir Medical announced late-breaking data for the company’s DynamX coronary bioadaptor system in complex patient population subsets from the INFINITY-SWEDEHEART randomized controlled trial (RCT), which compared the DynamX device to the contemporary Resolute Onyx zotarolimus drug-eluting stent (DES; Medtronic) for target lesion failure (TLF). The data include an analysis of patients with acute coronary syndrome (ACS), small vessel lesions, and lesions within the left anterior descending (LAD) artery.

The INFINITY-SWEDEHEART RCT is a prospective, multicenter, single-blind, randomized (1:1), registry-based clinical trial comparing the two devices in 2,400 patients. The trial is executed in partnership with the ongoing SWEDEHEART registry program in Sweden.

The subset findings were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC, and simultaneously published by Professor David Erlinge, MD, in The Lancet.

Prof. Erlinge, the study’s Principal Investigator, is head of the Cardiology Department at Lund University in Lund, Sweden.

“Historically, patients with ACS are at a higher risk for adverse events after percutaneous coronary intervention (PCI) in part because of higher rates of comorbidities, reduced heart function, and more frail patient condition,” commented Prof. Erlinge in Elixir Medical’s press release. “Analysis of this critical population was key to understanding the effects of the bioadaptor’s unique mechanism of action on improving safety and effectiveness after PCI.”

Prof. Erlinge continued, “With sustained reduction and plateauing of TLF after 6 months as compared to stents, the data further validate the substantial clinical benefit of the bioadaptor and its potential to impact the treatment and long-term success in high-risk patient populations.”

According to Elixir Medical, the 6-month clinical results in patients with ACS demonstrated TLF of 0.3% versus 1.8% (P < .018), translating into 83% reduction and significant benefit for DynamX bioadaptor compared to Resolute Onyx DES.

The company stated that additional analysis of clinically complex lesions associated with adverse DES outcomes, such as LAD artery and small vessels, demonstrate that the bioadaptor’s unique mechanism of action translated into significant clinical improvement compared to DES, with INFINITY-SWEDEHEART results reinforcing the outcomes reported in the BIOADAPTOR RCT.

The press release further noted that patients with lesions in the LAD vessels demonstrated 73% reduction (0.2% vs 2.2%) in TLF rate after 6 months with DynamX bioadaptor compared to treatment with DES. There were no TLF events in patients with small vessels (≤ 2.75 mm) in the DynamX bioadaptor arm compared to 1.8% TLF with DES after 6 months. Elixir Medical stated that the DynamX bioadaptor is a coronary implant designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, adaptive increase in blood flow volume, and providing plaque stabilization and regression.

The DynamX coronary bioadaptor system has received CE Mark approval in Europe. It is not approved for sale in the United States, where it has received Breakthrough Device designation from the FDA, advised the company.

Elixir Medical recently announced that the INFINITY-SWEDEHEART RCT 12-month data were presented at the European Society of Cardiology Congress in London, England, United Kingdom. The study met its primary endpoint of TLF noninferiority (2.35% vs 2.77%; P < .001).