Elixir Medical’s coronary implant, DynamX bioadaptor, has been proven to significantly reduce the risk of device-related cardiac events compared with current-generation drug-eluting stents in a landmark clinical trial in coronary artery disease (CAD).
During the post-market registry study (NCT06074549), the medical device diminished target lesion failure (TLF) by 48% compared to current-generation drug-eluting stent.
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TLF constitutes three common cardiovascular events surrounding the use of a stent, including cardiac death, ischemia-driven target lesion revascularisation and target vessel myocardial infarction.
This impact was seen from six months through to the two-year mark following the superiority analysis.
Alongside its impacts on TLF, DynamX Bioadaptor also offered a statistically significant reduction to target vessel failure (TVF) – an effect that was seen from six months to two years. The medical device offered similar clinical benefits in high-risk patients with acute coronary syndrome.
These results were first presented on 27 October at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference, which is currently ongoing in San Francisco. According to Elixir, these findings could “mark a major advance in coronary interventions”, which follows two decades of little progress in improving outcomes associated with arterial stenting.
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By GlobalDataIn a 28 October statement, head of cardiology at Lund University and principal investigator (PI) on the trial, David Erlinge, noted that these results highlight DynamX Bioadaptor’s potential to “restore coronary physiology after unlocking after half a year,” which he believes could ameliorate long-term clinical outcomes.
The DynamX bioadaptor has already obtained a European CE mark, as well as approval from the Japanese Pharmaceutical and Medical Device Agency (PDMA). The device also bagged breakthrough device designation from the US Food and Drug Administration (FDA) in 2024.
Addressing stent-related cardiovascular issues
In the modern CAD treatment landscape, percutaneous coronary intervention (PCI) through the insertion of stents is often used to widen the arteries and prevent heart attacks.
While this method is effective at improving blood flow, subsequent re-narrowing of the arteries following stent insertion, as well as clot formation around the device, can place patients at risk.
According to Elixir, DynamX bioadaptor can help mitigate these issues, as the coronary implant technology can regulate both blood flow and pressure by offering initial structural support. Following this, the bioabsorbable polymer within the device’s structure then dissolved, revealing a flexible structure that facilitates the artery’s natural pulsatility and overall function.
The global coronary stent market is currently on the up, with the sector estimated to pull in $4.3bn compared with the $3.8bn the industry made in 2024.
The leading player during 2024 in this sector is Medtronic, which made $323m in 2024. Though the Irish medtech takes the pole position, Boston Scientific follows closely behind, as the company brought in $307m through the sales of its coronary stents.
