, Sept. 23
/PRNewswire/ -- OrbusNeich today announced that six-month follow-up clinical trial data demonstrate the excellent 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 data were presented by Jochen Woehrle
, M.D., University of Ulm, Germany
, principal investigator of the study, in the first report clinical trial session at Transcatheter Cardiovascular Therapeutics (TCT) 2010 in Washington
The PERfECT STENT (A Prospective, Randomized 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. 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 0.34 mm was significantly 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. There was no definite and probable stent thrombosis reported in either arm of the study. Both patient groups received three months of dual antiplatelet therapy. In addition, the rates of TLR and MACE were lower in the investigational group compared to the control group.
"We 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," said Professor Woehrle. "This study supports the company's development efforts with the Combo Stent."
The Combo Bio-engineered Sirolimus Eluting Stent, or Combo Stent, which combines the Genous pro-healing technology for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation, is currently under clinical investigation.
Genous is OrbusNeich's patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
OrbusNeich's Genous Bio-engineered R stent has been commercially available in over 60 countries since 2005. The Genous stent has been proven as a safe, effective alternative to drug-eluting stents and is supported by data from more than 5,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous Bio-engineered R stent, as well as stents, balloons and guiding catheters marketed under the names of Blazer, R stent, Scoreflex, Sapphire and Sapphire NC. Development stage products include the Combo Bio-engineered Sirolimus Eluting Stent, or Combo Stent, which combines the Genous pro-healing technology for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.