Executive Summary

Just weeks after announcing it had CE-marked for sale in Europe the first bioengineered stent, Genous, Hong Kong firm OrbusNeich is pressing on with its clinical trial programme to substantiate the product's efficacy. The company has begun a global internet-based registry called e-HEALING, which will assess outcomes of 5,000 patients enrolled at over 100 centres; the device is currently only available through the registry. The registry is sufficiently large to generate the data needed to quantify the technology's safety profile, said the company. The company has also completed the design phase of an upcoming randomised trial, called HEALING III, which will involve angiographic follow up to compare Genous stents with bare metal stents both in conjunction with statin therapy. HEALING III is scheduled to start later this year or in early 2006.