February 1, 2011 – Despite the benefits of therapy with implantable cardioverter-defibrillators (ICDs), inappropriate shocks from the devices are common and place patients at a greater mortality risk. These were the conclusions drawn by a Dutch research team that examined the incidence, predictors and patient outcomes of inappropriate ICD shocks in a large, real-world patient population.

February 1, 2011 – A self-anchoring aortic heart valve has received the CE mark. With the approval, the Perceval S Sutureless biological valve, by the Sorin Group, is now commercially available in Europe.

January 31, 2011 – The first successful transcatheter implantation of a 27 mm transapical aortic valve prosthesis has been completed. The procedure was performed by Hendrik Treede, M.D., at the University Heart Center Hamburg using JenaValve’s transcatheter aortic valve implantation (TAVI) system. It was part of the company’s ongoing pivotal CE mark trial

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 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.