WASHINGTON, Oct. 14 OrbusNeich today announced that aninterim analysis of 12-month follow-up data from the global e-HEALING registryshow good safety and efficacy in the real-world use of the company's GenousBio-engineered R stent.
Presented by Professor Robbert de Winter, M.D., Ph.D., of the AcademicMedical Center in Amsterdam at the Transcatheter Cardiovascular Therapeuticssymposium, TCT 2008, in Washington, D.C., the data from 3,200 patients were atarget lesion revascularization (TLR) rate of 5%, a subacute thrombosis (SAT)rate of 0.4%, a late stent thrombosis (LST) rate of 0.3%, and a major adversecardiac events (MACE) rate of 8.5%.
"The data further support the use of Genous as an alternative to drug-eluting stents, especially in light of the relatively minimal dual-antiplatelet therapy requirements with the stent," said de Winter, a co-principal investigator of the study. "Patient compliance with extended dual-antiplatelet therapy due to cost and other factors such as patients facingimminent non-cardiac surgery are issues that we can address by using Genous."
OrbusNeich's e-HEALING clinical study is a multi-center, worldwide(outside the United States) prospective registry with 5,000 enrolled patientstreated with the Genous Bio-engineered R stent. The study protocol recommendsthat patients receive one month of clopidogrel treatment after the procedure.Clinical follow-up takes place at 30 days, six months and 12 months. Theprimary endpoint of the registry is target vessel failure at 12 months.
In a related presentation at TCT 2008, de Winter and his colleaguesreported data from the Academic Medical Center's single-center, real-worldstudy of the Genous stent in patients with predominantly complex lesions. Thedata, presented in an electronic poster, show a good one-year clinical outcomeregarding major adverse cardiac events, including a low incidence of stentthrombosis.
In the study, 236 patients were treated with Genous and completed 12-monthfollow-up. For the lesions treated, 64% were type B2 or C, 16% were chronictotal occlusion, and 23% were bifurcated. The TLR rate was 8.1%, and the MACErate was 13.6%. There was one patient with acute stent thrombosis at 24hours, two patients with SAT at seven and 18 days, and no LST observed.
Unlike drug-eluting stents, Genous, which is coated with an antibody,captures a patient's endothelial progenitor cells (EPCs) to accelerate thenatural healing process. EPCs circulate in the bloodstream and are involvedin the repair of blood vessels. When attracted to the surface of Genous, EPCsrapidly form an endothelial layer over the stent that provides protectionagainst thrombus and minimizes restenosis.
OrbusNeich designs, develops, manufactures and markets innovative medicaldevices for the treatment of vascular diseases. The company's productportfolio includes the Genous Bio-engineered R stent, an antibody-coateddevice that is the first-ever stent to capture a patient's endothelialprogenitor cells (EPCs) to accelerate the natural healing process followingplacement. Other products are stents, balloons and guiding catheters marketedunder the names of Blazer(TM), R stent(TM), Scoreflex(TM), Sapphire(TM),Sapphire(TM) NC, Avita(TM), Avita HP(TM), SafeCut(TM), Lumina(TM) and Saffron.
A global company, OrbusNeich is headquartered in Hong Kong and hasoperations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo; andShenzhen, China. OrbusNeich, which has provided cardiology devices tophysicians through its predecessor companies since 1979, today suppliesproducts to interventional cardiologists in more than 60 countries. For moreinformation, visit www.OrbusNeich.com.
The data presentations listed in this news release are available onOrbusNeich's Web site, which is located at www.orbusneich.com.
OrbusNeich is displaying the Genous Bio-engineered R stent and otherproducts at booth No. 1011 at TCT 2008.
Product images are available on request.