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Long Term Follow Up With Genous Stent Confirms Continuing Vascular Healing; Contrary To Delayed Restenosis With Drug Eluting Stents
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
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includes the R stent, the Avita PTCA dilatation catheter, the Avita HP high
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OrbusNeich
http://www.OrbusNeich.com
View drug information on Avita.
Long Term Urmaþi cu Genous stent Confirmã Continua vasculare Vindecarea; contrar Întârziat Restenosis Cu Drug Eluting Stents - Long Term Follow Up With Genous Stent Confirms Continuing Vascular Healing; Contrary To Delayed Restenosis With Drug Eluting Stents - articole medicale engleza - startsanatate