DIRECT II is a prospective, randomized, multi-center clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent-on-a-wire Integrated Delivery System and the Medtronic Resolute Integrity
drug-eluting coronary stent in 159 patients undertaken in support of CE Mark certification of the Svelte IDS.
About three-quarters underwent an elective stenting procedure, and slightly more than half received a
drug-eluting coronary stent.
When the analysis was confined to the 179 PCI patients (71%) who received a
drug-eluting coronary stent, the results shifted slightly in favor of PCI.
Successful management of patients with a
drug-eluting coronary stent presenting for elective, non-cardiac surgery.
"Incorporating Guidant's latest delivery technology promises to improve our current product line and give us entry into the next generation of
drug-eluting coronary stent systems earlier than originally anticipated.
The company said that Resolute Integrity Stent System features a novel
drug-eluting coronary stent with superior deliverability - the ability of the device to traverse the patient's vasculature and reach the blockage in the heart artery.
The company also received the FDA's nod for its second-generation Taxus Liberte
drug-eluting coronary stent system.
has received regulatory approval from Health Canada's Therapeutic Products Directorate (TPD) for use of the Endeavor
drug-eluting coronary stent (DES) system in the treatment of coronary artery disease.
Atlanta -- Patients with a
drug-eluting coronary stent had a 4.9% rate of cardiac death or myocardial infarction during the first year after they stopped daily treatment with clopidogrel, more than three times the rate in patients with bare-metal stents in a study with 743 patients.
The review included 5,342 patients at Prairie Heart who received their first
drug-eluting coronary stent during May 2003--December 2006.
The TAXUS Liberte stent is currently the market-leading
drug-eluting coronary stent system outside the U.S.
Abbott Vascular's drug eluting stent program is comprised of two flagship investigational products: the XIENCE V Everolimus Eluting Coronary Stent System and the ZoMaxx(TM)
Drug-Eluting Coronary Stent System.