CeloNova BioSciences has announced that first-in-man clinical trial results found that its Cobra PzF coronary stent system, which has an advanced nano-thin coating of Polyzene-F polymer, is a safe and effective routine treatment for real-world and complex patients with heart disease. The stent was associated with a low rate of target vessel revascularisation (3%).
Researchers discussed the findings during a live symposium titled “New therapies available in Germany but not in the USA: p-c-i live in partnership with TCT” at the recent Transcatheter Cardiovascular Therapeutics (TCT) 2014 meeting (13–17 September, Washington, USA). The symposium was moderated by Sigmund Silber (Germany) and Renu Virmani (USA).
The prospective, single-centre study included 100 patients, many of who presented with multivessel disease, complex lesions, and co-morbidities such as diabetes, hypertension, dyslipidaemia, atrial fibrillation, history of percutaneous coronary intervention (PCI), previous myocardial infarction, and more. According to a press release, researchers achieved 100% angiographic success.
Following treatment, patients were placed on a 30-day anticoagulant regimen of aspirin (1–2mg/kg/d) and clopidogrel (1–2mg/kg/d). At six-month follow-up, results show no stent thrombosis, no myocardial infarctions, one cardiac death due to terminal cardiac insufficiency (1%), and three-percent (3%) target lesion revascularisation, leading to 4% major adverse coronary event (MACE).
“The Cobra PzF coronary stent system’s six-month clinical performance is impressive given the wide variety of challenging patients in this study. Even more remarkable, and exciting, are the low target lesion revascularisaton and MACE rates as well as the absence of major bleeding complications related to the 30-day limit on dual-antiplatelet therapy,” says Luc Maillardlead investigator of the study. “These data add to recent animal studies showing that Polyzene-F nano-coating technology is associated with rapid healing and re-endothelialisation, and may reduce stent thrombosis and restenosis without the use of long-term blood thinning medication,” he adds.
The press release reports that the Cobra PzF coronary stent is made of cobalt chromium super alloy and is coated with an advanced nano-thin coating of polyzene-F polymer. The stent platform and the nano-coating technology are designed to impart thromboresistance, low inflammation, rapid and natural healing properties.