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 Genous(TM) 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.

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