FOLLOW UP WITH GENOUS STENT CONFIRMS VASCULAR HEALING.

The interim 18 month follow up results of the HEALING II study were presented on May 17, 2006 in Paris, France at the annual Paris Course on Revascularization (EuroPCR 2006) by Eric Duckers, MD, PhD, Head of Molecular Cardiology and Interventional Cardiologist at 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, which is intended to protect against thrombus and minimize restenosis.

During the course of this trial, 63 patients were treated at 10 centers in Belgium, Germany, and The Netherlands. As previously reported, the clinically driven target lesion revascularization (TLR) rate at six months and again at nine 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.

At the initiation of the trial, 18 month follow up was not planned; however, principal investigator Professor Patrick W. Serruys, MD, PhD (Chief of Cardiology at the Thoraxcenter) encouraged all investigators in the trial to ask patients to return for an 18 month angiographic follow up. Serruys was convinced that the effect of a stent directed at improving natural healing would show a regression of neointimal growth.

At the 18 month follow up, there were no new clinically driven TLR events or MACE reported. The thrombosis rate remained unchanged at 0%.

A meta analysis of several randomized trials comparing drug eluting stents (DES) both with and without polymers and bare metal stents (BMS) revealed a significant and persistent progression in clinical and angiographic restenosis in DES up to 36/48 months of over 60%. Intimal hyperplasia in BMS regressed between six months and three years by less than 10%. With the HEALING II patients, between six and 18 months late luminal loss significantly regresses by 18%.

"This significant regression of late luminal loss is unprecedented," commented Dr Duckers. "This effect appears to be facilitated by accelerated vascular healing induced by the EPC capture stent and indicates that the healing process improves long term."

These findings are instrumental to the design of the upcoming HEALING IIB study. This multi-center, prospective trial will assess the safety and effectiveness of the Genous Bio-engineered R stent in conjunction with optimal statin therapy and will include angiographic follow up at six and 18 months. HEALING IIB will be initiated in July 2006.

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, the Avita HP high pressure PTCA dilatation catheter, and the SafeCut dual wire dilatation catheter.

For more information, visit http://www.orbusneich.com.