January 31, 2011 – A new catheter used to treat coronary artery disease has received regulatory clearance in the United States and approval in Japan. The Trek and Mini-Trek systems, by Abbott, are used in angioplasty procedures and are designed to enable interventional cardiologists to open patients' narrowed coronary arteries.

The Trek system received the CE mark in May 2010.

January 31, 2011 – The U.S. Food and Drug Administration (FDA) has approved a system for accessing and delivering diagnostic, embolic and therapeutic materials into the peripheral vasculature. The Renegade HI-FLO Fathom Pre-Loaded System, by Boston Scientific, will be used by interventional radiologists for minimally invasive procedures to treat uterine fibroids and liver cancer.

January 28, 2011 – The Civil Division of the U.S. Department of Justice (DOJ) filed a civil False Claims Act lawsuit against Boston Scientific, Guidant LLC and other entities seeking additional payments related to faulty implantable cardioverter defibrillators (ICDs).

January 27, 2011 – The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) Supplement allowing more patients to participate in the ADVANCE trial. The bridge-to-transplant will let a third allotment of 94 more patients under a Continued Access Protocol (CAP).

January 27, 2011 – The first U.S.-procedure to use a new open-irrigated catheter was completed as part of the BLOCk-CTI trial. The study is using Boston Scientific’s Blazer Open-Irrigated Catheter to evaluate its safety and effectiveness in patients with sustained or recurrent type 1 atrial flutter.

January 27, 2011 – The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee agreed this week that carotid stenting was safe for patients at standard surgical risk.

January 27, 2010 – The U.S. Food and Drug Administration (FDA) expanded the indication for the Bard Peripheral Vascular LifeStent and LifeStent XL nitinol self-expanding stents for the treatment of lesions up 240 mm in length.

January 27, 2011 – The U.S. Food and Drug Administration (FDA) granted conditional investigational device exemption (IDE) approval to evaluate the safety and effectiveness of a cath lab robotic navigation system to direct guidewires and place coronary stents.

January 27, 2010 – An ergonomic, peel-away introducer sheath was launched this week to facilitate placement of electrophysiology device leads and catheters in the venous system.

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