OrbusNeich's six-month follow-up clinical trial data demonstrated safety profile and efficacy of the company's Genous Bio-engineered R stent in combination with a paclitaxel-coated balloon for the treatment of de novo coronary artery disease
The PERfECT Stent (A Prospective, Randomised Trial Evaluating a Paclitaxel-Eluting Balloon in Patients Treated with Endothelial Progenitor Cell Capturing Stents for De Novo Coronary Artery Disease) study compared the combination of a paclitaxel-coated balloon (SeQuent Please, B Braun) with a Genous stent to the Genous stent alone in 120 patients undergoing percutaneous coronary intervention (PCI).
The primary endpoint of the study was in-stent late loss at six months, whereas the secondary endpoints included diameter stenosis, binary restenosis rate, target lesion revascularization (TLR), major adverse cardiac events (MACE) and stent thrombosis.
The in-stent late loss at six months follow-up of 0.34mm was lower in the patient group treated with the Genous stent in combination with a paclitaxel-coated balloon when compared to 0.88 mm in the control group.
University of Ulm, Germany professor Jochen Woehrle said that they are very encouraged by the good clinical and safety outcomes seen in patients treated with a combination of a paclitaxel-coated balloon and pro-healing technologies with only three months of dual antiplatelet therapy. This study supports the company’s development efforts with the Combo Stent.