OrbusNeich's Genous™ Stent is Safe and Effective in Cases Where Prolonged Dual Antiplatelet Therapy is Not Advisable as Presented at EuroPCR 2011
PARIS, May 19, 2011 /PRNewswire/ -- OrbusNeich announced that data from multiple clinical trials supporting the safety and efficacy of the Genous Stent in cases where prolonged dual antiplatelet therapy (DAPT) is not advisable were featured today during the HEALING Symposium titled "How to assess and treat patients who are not suitable candidates for prolonged dual antiplatelet therapy" at EuroPCR 2011 in Paris.
Presenters discussed current treatment alternatives to drug eluting stents (DES) for patients who are contraindicated for prolonged DAPT and the benefits of the Genous endothelial progenitor cell (EPC) capture technology for addressing these challenging cases. The symposium also explored the potential for new imaging tools to assess stent apposition and arterial healing in a clinical setting.
Robbert de Winter, M.D., Ph.D., of the Academic Medical Center, Amsterdam, presented three-year follow-up data that demonstrated the safety and efficacy of the Genous Stent in a large real-world patient population with mostly complex lesions and estimated high risk for restenosis. At three years, the definite stent thrombosis (ST) in 405 unselected patients treated with the Genous Stent was 0.5%, which was unchanged from one year, and there was a probable ST in one patient, which increased the rate of probable ST to 1.0% at three years compared to 0.8% at one year. In addition, the target lesion revascularization (TLR) rate at three years was 14.2% versus 10.6% at one year.
"These long-term data show no additional cases of definite stent thrombosis between one and three years attests to the durability and excellent safety profile of the Genous Stent," said Prof. de Winter.
Jonathan Hill, M.D., of King's College Hospital in London discussed the need to modify practices with an awareness of bleeding risk. He defined the predictors of high risk for bleeding to be age (>80), a previous bleeding episode, gender (female), renal insufficiency and low and high body mass index (BMI).
"For patients who are known to be at an increased risk for bleeding or requiring urgent surgery, Genous is an ideal treatment strategy," said Dr. Hill.
In a presentation entitled "Endothelial progenitor cell-capture technology: mechanism of action and potential benefits," Eric Duckers, M.D., Ph.D., of Erasmus University Medical Center in The Netherlands presented clinical data from an ex vivo arteriovenous (AV) shunt model of human circulating blood which demonstrated that the Genous Stent increased the rate of endothelialization and reduced thrombogenicity compared to a bare metal stent (BMS).
"These data demonstrate the importance of CD34+ cells for endothelialization and the prevention of thrombosis," said Dr. Duckers. "This mechanism of early endothelialization supports the design of the unique EPC capture technology of Genous."
Stephen Wai-Luen Lee, M.D., Chief in Cardiology, Queen Mary Hospital at the University of Hong Kong, presented data from a pilot study on very early healing of the Genous EPC capturing stent using frequency domain optical coherence tomography (FD-OCT) technology – the EGO Study in 50 patients (still enrolling). By 15 days, a very significant portion of the stent struts were covered by neointima, and close to 100% strut coverage was observed with the Genous Stent at 28 days.
"The degree of stent coverage over a time frame of two to six weeks has been documented graphically, revealing a progressive healing with stent coverage over time and possibly signifying the healing benefits of the EPC capturing technology," said Prof. Lee. "Such early findings have never been documented or reported in other types of stents, BMS and DES included."
Michael Haude, M.D., of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, and Sigmund Silber, M.D., Ph.D., of Kardiologische Klinik Dr Muller, Munich, chaired the event.
"The Genous Stent is a good option for patients with relative contraindications to DES, as shown in these presentations and other recent studies, including the publication of the full dataset from the global e-HEALING registry in EuroIntervention this February," said Prof. Silber. "The body of evidence continues to grow in support of safety and effectiveness of the Genous EPC capture technology for treating these challenging cases."
Genous is OrbusNeich's patented 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.
The Genous Stent, which has been commercially available in more than 60 countries since 2005, has been proven as a safe, effective alternative to drug eluting stents and is supported by data from more than 6,000 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 Stent, as well as other stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II 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. Follow OrbusNeich on Twitter at www.twitter.com/OrbusNeich.