Elixir Medical’s triple drug-eluting coronary implant has met the primary safety and efficacy endpoints in the DESyne BDS Plus Randomised Controlled Trial (RCT).
The data was presented at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium 2023 in San Francisco, US, on 25 October.
DESyne BDS Plus RCT is a prospective, multi-centre, single-blind, randomised Phase II clinical study (NCT05033964) evaluating the safety and efficacy of the DESyne BDS Plus compared to a polymer drug-eluting stent (DES) to treat coronary artery lesions.
The primary endpoint of the study was successfully met, with a significant difference in the target lesion failure (TLF) rate between the two groups. No cases of probable or definite stent thrombosis, heart attacks related to the treated vessel, or cardiovascular deaths were reported with the device.
The secondary endpoint, which assessed the late lumen loss within the stented blood vessel, was similar between the two devices.
Elixir claims that DESyne BDS Plus is the world’s first coronary implant that releases three types of drugs. Another significant feature of DESyne BDS Plus is its ability to deliver antithrombotic drugs specifically to the site where the stent is implanted. The targeted approach aims to improve the safety and effectiveness of the device.
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Elixir has several devices in the pipeline, including its DynamX Coronary Drug-Eluting Bioadaptor, which was tested on 445 patients in the BIOADAPTER RCT trial (NCT04192747), meeting its primary endpoint in May 2023.
A market model by GlobalData forecasts the drug-eluting stent market to be worth more than $2.3bn in the US by 2030.
GlobalData is the parent company of Clinical Trials Arena.