Elixir Medical’s DynamX Bioadaptor scaffold for coronary artery disease (CAD) has produced positive results in a randomised controlled trial comparing the implant to a drug-eluting stent.
Presenting the data at a Hot-Line session on the final day of the 2024 European Society of Cardiology Congress held in London, UK, from 30 August to 2 September, Elixir said trial (NCT04562805) – named INFINITY-SWEDEHEART – met its primary endpoint of target lesion failure (TLF) non-inferiority.
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The study’s principal investigator David Erlinge said at the Hot-Line session: “The results confirm the novel impact of the Bioadaptor in coronary artery disease treatment through its unique mechanism of action of restoring the haemodynamic modulation of a diseased artery.”
The patients enrolled in the study were those with chronic coronary syndrome or acute coronary syndrome and were indicated for a percutaneous intervention with stent implantation. A total of 2,400 patients across sites in Sweden were involved in the registry-based clinical trial.
Elixir was comparing its implant against Medtronic’s Resolute Onyx zotarolimus, a stent that releases the immunosuppressant drug zotarolimus. After 12 months, the DynamX bioadaptor, which instead releases sirolimus – also an immunosuppressant – had a TLF of 2.35% versus 2.77% for the marketed stent.
A prespecified landmark analysis – a secondary endpoint – after six months demonstrated statistically significant reductions in TLF and target vessel failure (TVF) with DynamX.
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By GlobalDataElixir’s device is comprised of three cobalt-chromium helical strands that separate following natural resorption of a biodegradable polymer coating, helping to restore vessel health. Whereas the device behaves like a stent for the first six months, its unique features appear after this following the separation of the strands. This allows the maintenance of flow lumen and the restoration of haemodynamic modulation.
Whilst percutaneous coronary interventions (PCIs) are one of the most common cardiovascular procedures, with nearly seven billion procedures conducted in 2023, according to analysis by GlobalData. Stents are one of the go-to medical devices to treat the disease, with the coronary stent market estimated to be worth $4.3bn in 2023, according to analysis in the same report by GlobalData.
Professor Davide Capodanno, a member of the working group on thrombosis of the ESC, said during the session that “if these findings are confirmed in longer terms and with other control arms, this technology could become a serious contender to the paradigm of drug-eluting stents”.
Whilst PCIs are generally a safe procedure, implantation stents can be associated with annual recurring adverse event rates of 2%-3%. Complications that can occur include restenosis, thrombosis, and revascularisation issues.
Elixir stated the performance of its technology, which received US Food and Drug Administration (FDA) breakthrough therapy designation in March 2024, was driven by the low numbers of target vessel myocardial infarction, ischemia-driven target lesion revascularisation, and cardiovascular death.
At the previous EuroPCR conference in Paris in 2023, Elixir reported positive one-year results from the BIOADAPTOR RCT trial (NCT04192747), which enrolled 445 patients with ischemic heart disease due to de novo, native coronary artery lesions. As with the most recent trial, BIOADAPTOR RCT compared Elixir’s device to the Resolute Onyx system.
