OrbusNeich Release: Pro-Healing Coronary Stent Demonstrates Impressive Patient Results

HONG KONG, HOEVELAKEN, The Netherlands, and FORT LAUDERDALE, Fla., Nov. 8 /PRNewswire/ -- The final results of the HEALING II study were presented on October 21, 2005 in Washington, DC at the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting by Professor Patrick W. Serruys, MD, PhD, Chief of Interventional Cardiology, and Eric Duckers, MD, PhD, both of the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. The HEALING II study evaluated the safety and efficacy of the Genous Bio-engineered R stent. Unlike drug eluting stents (DES) which inhibit tissue growth, Genous captures a patient’s endothelial progenitor cells (EPCs) to accelerate the natural healing process. Once attached, EPCs rapidly form a protective endothelial layer over the stent, providing immediate protection against thrombus and minimizing restenosis.

During the course of this trial, 63 patients were treated at 10 centers in Belgium, Germany, and The Netherlands. The HEALING II patient population was challenging: 67% had hyperlipidemia, 52% had a family history of coronary artery disease, and 24% had previously experienced a myocardial infarction. The index lesions had an average reference diameter of 2.63mm, a minimal lumen diameter of 0.98mm, and an average lesion length of 9.83mm. 57% of all lesions were Type B2/C.

The clinically driven target lesion revascularization (TLR) rate at six months was 6.3% with an overall major adverse cardiac events (MACE) rate of 7.9%. Additionally, no subacute or late thrombosis was reported even with a recommended 30 days of dual antiplatelet therapy.

Professor Serruys, principal investigator of the trial, elaborated, “When we set up this study, we recognized that it would be critical to assess EPC levels in the HEALING II patients so we could mechanistically understand the functionality of the EPC capture device. The subsequent analysis of the relationship of EPC levels to clinical outcomes is quite compelling.”

This analysis measured the quantity of EPCs circulating in the bloodstream and identified two patient subsets -- those with low and normal levels of EPCs. A strong correlation was observed between EPC quantity and clinical responses. All restenotic and cardiac events were restricted to patients with low EPCs. For patients with normal EPC levels there were no TLR or MACE at six months follow up. In addition, late loss for the normal EPC group was 0.48mm and the resulting binary restenosis rate, defined as greater than 50% blockage, was 0%, indicating a healthy healed artery.

“These results for the normal EPC group are impressive,” commented Dr Duckers. “Another fascinating finding of this study is that the vast majority of patients with normal EPC levels were on statin therapy while most in the low EPC group were not. HEALING II patients on statins exhibited more than double the number of EPCs than those not on statins.”

These findings are instrumental to the design of the upcoming HEALING III randomized study. HEALING III will assess the effect of statin therapy combined with EPC capture and bare metal stents. HEALING III will be initiated in early 2006.

“The results indicate Genous is effective, especially for patients with normal EPC levels,” said Sam Rasmussen, President and CEO. “This pro-healing approach is also a safe alternative to drug eluting stents for those patients who cannot be on extended dual antiplatelet therapy.”

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, Vice President of Sales & Marketing, at +31 33 254 1150 (The Netherlands). Also, please visit our website at http://www.OrbusNeich.com .

OrbusNeich

CONTACT: Samuel Rasmussen, President & CEO, +011-852-2802-2288 in HongKong, or David Camp, Vice President of Sales & Marketing, at+011-31-33-254-1150 in The Netherlands, both of OrbusNeich

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