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ABILITY DIABETES-GLOBAL (ADG), is the World’s largest Randomized Controlled Trial (RCT) for patients with DM (Diabetes Mellitus), comparing head-to-head the Sirolimus eluting stent , Abluminus DES+ (Concept Medical Inc.) with the XIENCE family of DES (Abbott Cardiovascular).
Prof. Antonio Colombo shares similar sentiments. “We completed enrollment of a landmark trial. The first trial comparing two different DES in 3050 diabetics. The results will be a benchmark for any new or old PCI technology”, he said.
“I would like to thank all the site investigators, operators, technicians, and study coordinators, the Cardiovascular European Research Center (CERC), and Mount Sinai and ICAHN School of Medicine who played a stellar role in achieving this,” exuded Prof. Marie-Claude Morice (CERC), “in particular the CERC and Mount Sinai research team who conducted the trial so well at such a complex time; their commitment is unique and will contribute to the success of the trial, a potentially significant improvement for Diabetic patients with cardiovascular disease”.
Instituto Dante Pazzanese de Cardiologia (Brazil) led by Dr Daniel Chamié, and the National Heart Foundation Hospital & Research Centre (Bangladesh), led by Dr Fazila Malik, played a major role in completing the enrollment followed by OLVG (The Netherlands) led by Dr Maarten Vink.
Abluminus DES+ (Concept Medical Inc.), which has regulatory approvals in Europe and other countries, uses a proprietary Envisolution technology to provide homogenous drug delivery by coating the stent surface and exposed parts of the balloon and on the edges of the balloon. In clinical studies conducted at other centers Abluminus DES+ has proven effective in managing patients with DM.
Prof. Alexandre Abizaid, who has widely used the product, “I would like to congratulate Concept Medical and all the investigators for completing the largest randomized trial in PCI for diabetic patients. This 3000-patient trial tested a novel DES technology called Abluminus which is the combination of a Sirolimus eluting stent crimped on a drug coated balloon. This is certainly a landmark study in the modern era of complex coronary intervention”.
About Concept Medical Inc (CMI):
CMI is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug / pharmaceutical agent across the luminal surfaces of blood vessels.
