HONG KONG, HOEVELAKEN, The Netherlands and FORT LAUDERDALE, Fla., Aug. 22, /PRNewswire/ -- OrbusNeich announced that it has received CE Mark (Conformite Europeenne) approval for its Genous Bio-engineered R stent. Genous is at the forefront of the accelerated natural healing approach to protect against thrombus and minimize restenosis. Genous promotes tissue healing to occur in a rapid and controlled manner at the stent injury, rather than inhibiting healing, including endothelial coverage, with potent antiproliferative drug eluting stents. Commercialization will be a controlled release in Europe and other international markets next month through an internet-based registry, e-HEALING.
"This CE Mark literally marks the beginning of a new pro-healing stenting era for interventional cardiology and all of us at OrbusNeich are pleased and excited to be a part of this," said Samuel Rasmussen, President and CEO. "Genous has an emphasis on gentler, safer, more natural ways for treating patients."
Interim results from the most recent clinical study, HEALING II, were presented in May at the EuroPCR in Paris, France. This analysis showed that patients who received a Genous stent and were also on statins had better clinical outcomes. HEALING stands for Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth. A HEALING III multifactorial clinical study will start in the next few months to assess the effect of statin therapy with Genous versus bare metal stents.
"The primary function of a stent is to protect and enhance a patient's life," said David Camp, Vice President Sales and Marketing. "Genous is not a drug eluting stent, there is no polymer or drug. The stent is coated with an antibody, that captures a patient's own circulating endothelial progenitor cells. The whole concept is to passivate the stent within minutes to hours with a layer of endothelial cells. This not only minimizes restenosis but also provides immediate protection against thrombus." Camp continued, "We feel very comfortable with this technology's safety profile."
Martin B. Leon, MD, Associate Director, Center for Interventional Vascular Therapy, Division of Cardiology, Columbia University Medical Center, commented, "This is a promising development in the field of interventional cardiology, distinct from the basic concept of tissue inhibition of drug eluting stents. The Genous technology is designed to act as a 'magnet' for healing endothelial progenitor cells to create a rapid and safe monolayer coverage for the implanted stent. I encourage OrbusNeich to continue to invest in this technology for the benefit of patients worldwide."
OrbusNeich's mission is to urgently deliver medical technology to patients of the world. It has a global reach, supplying medical devices for vascular disease in over 60 nations through sales offices in eight countries, manufacturing operations in The Netherlands and China, and research and development facilities in the United States and Germany. The product portfolio also includes the R stent, the Avita PTCA dilatation catheter, and the SafeCut dual wire dilatation catheter.
For more information, please contact Samuel Rasmussen, President & CEO, at +852 2802 2288 (Hong Kong) or David Camp, VP Sales & Marketing at +31 33 254 1150 (The Netherlands). Also, please visit our website at http://www.OrbusNeich.com .
OrbusNeichCONTACT: Samuel Rasmussen in Honk Kong, President & CEO,+011-852-2802-2288, or David Camp in The Netherlands, VP Sales & Marketing,+011-31-33-254-1150, both of Orbus Medical Technologies
Web site: http://www.OrbusNeich.com/
