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Healing Stent Nine Month Mace Rate Similar to Drug Eluting Stents |
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02 Mar 2006 |
SINGAPORE, Singapore | Feb 28, 2006 | The nine month clinical follow up results of the HEALING II study were presented on February 27, 2006 at the 15th Annual Singapore Live congress by Robbert de Winter, MD, PhD, Director of the Catheterization Laboratory, Academic Medical Center, Amsterdam, The Netherlands. The objective of the 10 center, 63 patient HEALING II study is to demonstrate the safety and stent related healing response to the GenousTM Bio-engineered R stent, which received CE mark in August 2005.
The Achilles’ heal of stenting, restenosis, has been significantly reduced with drug eluting stents (DES); however, the Achilles’ heal of DES seems to be stent thrombosis due to purposely delayed healing. DES require long term dual antiplatelet therapy, which if discontinued prematurely may result in stent thrombosis with its inherent high mortality rate. Genous is the world’s first stent designed to accelerate the natural healing response by capturing a patient’s own endothelial progenitor cells (EPCs) from the blood stream. Once captured, EPCs rapidly form a protective endothelial layer over the stent, providing protection against thrombus and minimizing restenosis.
Dr. de Winter presented an analysis of the nine month results which demonstrated a clinically driven target lesion revascularization (TLR) rate of 6.3% and a major adverse cardiac events (MACE) rate of 7.9%. There was no subacute or late thrombosis reported despite the protocol recommendation of only one month dual antiplatelet therapy.
Stated Dr. de Winter, “Tellingly, there were no additional events since the six month angiographic follow up, indicating that the healing process was stabilized.”
The six month follow up was presented last October at the 2005 TCT by principal investigator Professor Patrick W. Serruys, MD, PhD, Chief of Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. During the HEALING II study, Professor Serruys recognized it would be critical to correlate the number of EPCs per patient with clinical outcomes. A strong relationship was identified. For patients with normal levels of EPCs, there was an absence of any TLR or MACE. Additionally, the late loss at six month follow up was 0.48mm and the binary restenosis was 0%.
“These low MACE and TLR rates are impressively more in the realm of results from drug eluting stent trials than those of bare metal studies,” commented Serruys. “Additionally, Genous’ safety profile makes this an attractive option for treating patients at higher risk of thrombosis.”
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 10 countries, manufacturing operations in The Netherlands and China, and research and development facilities in the United States. 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, VP Sales & Marketing at +31 33 254 1150 (The Netherlands). Also, please visit our website at www.OrbusNeich.com.
SOURCE: OrbusNeich |
