OrbusNeich's Genous(TM) Bio-engineered R Stent(TM) Demonstrates Impressive Results In Higher Risk Patients

Main Category: Vascular
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 23 Apr 2009 - 4:00 PDT

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OrbusNeich's pro-healing stent technology was featured at a symposium during Angioplasty Summit TCT Asia Pacific 2009 at the Convention Center of Sheraton Grande Walkerhill Hotel in Seoul, South Korea.

Presented by Margo Klomp, MD from the Academic Medical Center (AMC), Amsterdam, The Netherlands, final adjudicated 12 month follow up results from the randomized AMC single center TRIAS High Risk (HR) study showed a slightly higher target lesion revascularization (TLR) rate with the Genous treated patient group compared with patients receiving the Taxus drug eluting stent, but there were no stent thrombosis events at any time period in the 98 patient Genous group with only one month of dual antiplatelet therapy (DAPT). In the 95 patient Taxus cohort, the stent thrombosis rate was 4.2%, including late stent thromboses at 155 and 200 days, even though all patients were on DAPT at the time of stent thrombosis. Furthermore, the composite of death and myocardial infarction for Genous was 4.1% versus 7.3% for Taxus. "Within a month we will complete two year follow up on these patients and we anticipate these results will hold up longer term," said Klomp.

In a separate study involving 446 consecutive patients presented with an acute myocardial infarction (AMI) treated with Genous, Harry Suryapranata, MD, PhD, from Isala Klinieken in Zwolle, The Netherlands, presented 30 day follow up with only one patient (0.2%) having a stent thrombosis. Suryapranata commented, "This rate is impressively low given the highly thrombotic environment associated with AMI patients." Longer term follow up is ongoing.

Juan F Granada, MD, medical director of the Skirball Center for Cardiovascular Research at Columbia University Medical Center, presented results from pre-clinical models demonstrating the effectiveness in combining OrbusNeich's pro-healing cell capture with their fully absorbable drug elution technologies to address the shortcomings with current drug eluting stents (DES), namely the safety concerns associated with the delay and often lack of endothelialization. "In multiple models we have results indicating that this new technology appears to effectively regulate neo-intimal growth, while at the same time promotes the restoration of the arterial wall," explained Granada. These studies highlight the development progress with the next generation of pro-healing drug eluting stent (SES) featuring a combination of endothelial progenitor cell (EPC) capture technology and the abluminal deposition of a fully-absorbable sirolimus eluting matrix.

"Each of these complex technologies on their own offer solutions to the interventionalist," said Seung-Jung Park, MD, PhD, chairperson of the symposium. "By integrating these onto one innovative platform, OrbusNeich is making tremendous strides in being able to offer a single stent addressing multiple concerns."

Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient's EPCs to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent, providing a safe and effective alternative to DES.

OrbusNeich designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Other products in the company's product portfolio are stents, balloons and guiding catheters marketed under the names of Blazer(TM), R stent, Scoreflex(TM), SafeCut(TM), Sapphire(TM), Sapphire NC, Avita(TM), Avita HP, and Lumina(TM).

A global company, OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, FL; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China. OrbusNeich, which has provided cardiology devices to physicians through its predecessor companies since 1979, today supplies products to interventional cardiologists in more than 60 countries.

Source: OrbusNeich