Elixir Medical to Present One-Year Outcomes from INFINITY-SWEDEHEART Trial at ESC Congress 2024

Elixir Medical, a pioneering company in cardiovascular technology, has announced the forthcoming presentation of one-year clinical outcomes from the INFINITY-SWEDEHEART Randomized Clinical Trial (RCT) at the ESC Congress 2024 in London. This trial involves 2,400 patients and aims to compare the efficacy of the DynamX Coronary Bioadaptor System against the contemporary Resolute Onyx™ zotarolimus drug-eluting stent (DES).

Current treatments for coronary artery disease (CAD) typically focus on creating a fixed flow lumen in the artery. However, these treatments often face limitations as the arteries tend to re-narrow over time, leading to a high rate of major adverse events (MACE) which can reach up to 50% by ten years and continue to increase annually without plateauing. The DynamX bioadaptor aims to overcome these limitations by not only establishing a flow lumen but also restoring essential vessel functions. This includes hemodynamic modulation of the artery and reducing plaque progression, thereby maintaining a low adverse event rate that levels off after six months.

Elixir Medical's CEO, Motasim Sirhan, highlighted that earlier studies, such as the BIOADAPTOR-RCT study, have shown a significant 65% reduction in clinical events in de novo lesions over two years when compared to the Resolute Onyx DES. The INFINITY-SWEDEHEART RCT is expected to provide further evidence of the DynamX bioadaptor's performance in a broader patient population, including those with acute coronary syndrome (ACS).

The INFINITY-SWEDEHEART trial has enrolled 2,400 patients across 20 sites in Sweden. It is conducted through the SWEDEHEART registry program, a national collaborative research initiative that supports the development of heart disease therapies based on evidence. The Uppsala Clinical Research Center (UCR), a non-profit organization that provides clinical research services globally, collaborates on the study's management.

The trial's data will be presented by Dr. David Erlinge, head of the Cardiology Department at Skane University Hospital in Lund, Sweden. The presentation, titled "INFINITY-SWEDEHEART - Percutaneous coronary intervention with a bioadaptor compared to a contemporary drug-eluting stent – one-year primary outcomes," will take place during a Hot Line session at the ESC Congress 2024. Following the presentation, there will be a review and panel discussion on the findings.

The INFINITY-SWEDEHEART trial is designed as a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical study. It aims to compare a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in a real-world patient population. The trial is part of the ongoing SWEDEHEART registry program, which began in 2009 to support evidence-based therapeutic developments in heart disease.

The DynamX Coronary Bioadaptor System, recognized by the U.S. Food and Drug Administration (FDA) as a breakthrough technology, is the first coronary implant designed to restore hemodynamic modulation in the coronary artery. This is demonstrated through restored vessel pulsatility, compliance, and adaptive increase in blood flow volume. It also aims to stabilize and regress plaque, translating to lower clinical event rates that plateau between one and two years, as seen in the BIOADAPTOR RCT study. The DynamX system is CE-marked but not yet available for sale in the United States.

Elixir Medical, headquartered in Milpitas, California, is focused on developing innovative platforms to treat coronary and peripheral artery diseases, offering transformative technologies that hold the potential to improve clinical outcomes for millions of patients worldwide.