Archive for April, 2008

Medtronic Defender embolic protection filter gets CE marking

Medtronic Logo Medtronic Inc. has received CE marking approval for the Defender embolic protection filter to be used during minimally invasive procedures in carotid arteries and saphenous vein grafts. The filter acts as a basket during the stenting procedure, allowing sufficient blood flow while trapping embolic debris. Without this protection, the debris can flow into other portions of blood vessels and lead to stroke.

XIENCE V Everolimus Eluting stent more effective than TAXUS Paclitaxel-Eluting stent

Abbott LogoA study published in the Journal of the American Medical Association (JAMA) indicated that the use of Abbott Laboratories‘ XIENCE™ V Everolimus Eluting Coronary Stent System in patients with coronary artery disease resulted in a 50% reduction in vessel renarrowing. It also showed an observed 42% reduction in major adverse cardiac events (MACE) at one year in the patients using XIENCE V Everolimus Eluting Coronary Stent System, as compared to the TAXUS® Paclitaxel-Eluting Coronary Stent System.

Thoratec HeartMate II gets FDA nod

Thoratec LogoThoratec Corporation has received FDA approval for its PMA (PreMarket Approval) application, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure. The system supports the weakened heart of younger adults who are at risk of dying while awaiting a heart transplant.

Boston Scientific gets Japanese approval for heart failure lead

Boston Scientific has received regulatory and reimbursement approvals from Japan for its Acuity Steerable heart failure lead. The company intends to launch the product in Japan immediately. After being implanted, the lead enables physicians to change the stimulation site in the heart without any invasion, the company said.

Carotid artery stenting as effective as surgery

A study published in the New England Journal of Medicine has shown that the use of carotid artery stenting to open severely blocked carotid arteries is as effective in protecting people from heart attack, stroke and death as surgery. The research was based on the three-year data from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) study of Johnson & Johnson’s Precise nitinol stent and Angioguard guidewire.