Published Data From e-HEALING Registry Demonstrate Good Clinical Outcomes With Low Incidence of Repeat Revascularization and Stent Thrombosis for OrbusNeich’s Genous(TM) Stent
HONG KONG, Feb. 22, 2011 /PRNewswire/ — OrbusNeich today announced that 12-month follow-up data from the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry published in the February issue of EuroIntervention demonstrated good clinical outcomes with low incidence of repeat revascularization and stent thrombosis (ST) for the company’s Genous Stent.
Target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization (TVR), was 8.4 percent at 12 months. The composite of death, MI or target lesion revascularization (TLR) occurred in 7.9 percent of the patients. TLR and ST were 5.7 percent and 1.1 percent, respectively.
“The good clinical outcomes for the Genous Stent in real-world use, especially the low incidence of stent thrombosis, demonstrate that the pro-healing approach of the Genous Stent is effective for a range of challenging patient groups,” said Professor Sigmund Silber, M.D., Ph.D., of the Kardiologische Klinik Dr Muller, Munich, co-principal investigator and one of the lead authors of the publication. “As shown previously in several subset analyses of the e-HEALING registry, the Genous Stent produces exceptional outcomes in diabetic and elderly patients.”
e-HEALING, a multi-center, worldwide prospective clinical registry conducted in 31 countries outside of the United States at 144 centers, included 4,939 patients with at least one lesion suitable for non-urgent percutaneous coronary intervention (PCI) and Genous Stent implantation. The mean age of the study population was 63 years, and 79 percent of patients were male. In addition, 25 percent of patients in the study cohort had diabetes mellitus, and 37 percent had a prior MI. On average, 1.3 lesions per patient were treated – 97.7 percent were de novo lesions, and 10 percent were bifurcation lesions. For the lesions treated, 49 percent were type B2/C lesions. At the 30-day visit, 83 percent of the patients were on dual anti-platelet therapy (DAPT), 59 percent at six months and 34 percent at 12 months, respectively. The 12-month primary outcome was TVF, and secondary outcomes included composite of cardiac death, MI or TLR, and individual outcomes, including ST.
The Genous Stent is featured in two additional publications in the February issue of EuroIntervention. Scacciatella et al. reported on a single center registry with two-year outcomes in 61 patients with a high risk for restenosis who cannot receive drug-eluting stents for various reasons, including those who need surgery within two months and those with a high bleeding risk or who are allergic to aspirin. Martin-Yuste et al. presented another single center registry involving 78 patients with high comorbidities who required chronic anticoagulation due to atrial fibrillation, mechanical valve prosthesis, cardiomyopathy or prior emboli.
The Genous Stent was also featured in the editorial by Emanuele Barbato, M.D., Ph.D., and William Wijns, M.D., Ph.D., of the Cardiovascular Center, Aalst, Belgium, and in the introduction written by Patrick W. Serruys, M.D., Ph.D., of the Erasmus Medical Center, Rotterdam, the Netherlands, who is editor-in-chief of EuroIntervention.
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 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 Stent, as well as other stents and balloons marketed under the names of Blazer(TM), R stent, Scoreflex(TM), Sapphire(TM) and Sapphire NC. Development stage products include the Combo(TM) 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.