It’s been EuroPCR 2015 week and many companies are pointing us at the good news being presented about their products. One such, Biosensors says a first study has demonstrated rapid early healing for its BioFreedom™, a novel polymer and carrier-free drug-coated stent (DCS). Results in the first twelve months demonstrate rapid strut coverage, suggesting an early healing profile for patients using BioFreedom.
The BioFreedom stent features an abluminal coating of Biolimus A9™ (BA9™), avoiding the use of a polymer or other carrier. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents. In its First-in-Man (“FIM”) study, treatment with BioFreedom demonstrated excellent twelve-month late lumen loss and sustained safety up to five years, including absence of definite and/or probable stent thrombosis.
Presented by Professor Stephen Lee, Division of Cardiology, Queen Mary Hospital, University of Hong Kong, Optical Coherence Tomography (OCT) analysis demonstrated that 86% of struts were covered at one month, and 97% at five months in a 100 patient population. The BioFreedom stent also showed effective neointimal suppression at nine months and favourable clinical outcomes at twelve months.
An average 85.77% of struts were covered at one month, 97.14% at five months, and 99.55% at nine months. Neointimal thickness remained low over the study follow-up, reaching 0.10mm at nine months, thereby confirming the antiproliferative effect of the drug. At twelve months, there was a TLR rate of 4%. No other incidents of MACE were recorded, and no definite or probable late stent thrombosis was observed.
BioFreedom has received CE Mark approval and is currently available in select markets. Biosensors has also received conditional IDE approval to conduct a US-based clinical trial of BioFreedom, designed to collect additional safety and effectiveness data.
“This study provides proof of concept for a polymer-free biolimus-coated stent”, commented Prof. Lee. “BioFreedom demonstrated an early healing profile, in the form of rapid early strut coverage, while retaining its efficacy in terms of neointimal suppression at nine months and clinical outcomes at twelve months. If supported by long-term clinical results, this concept could have a major impact on the future development of new stent platforms.”
Source: Biosensors International Groupd Ltd.