April 23, 2012 - Boston Scientific Corp. announces that it has completed enrollment in the REPRISE I clinical trial, which is designed to evaluate the acute safety of the Lotus Aortic Valve System, the first transcatheter aortic valve replacement (TAVR) device of its kind for patients with severe aortic valve stenosis that is both fully repositionable and retrievable prior to release. This prospective, single-arm feasibility study enrolled 11 patients at three sites in Australia. Results from the REPRISE I trial are scheduled to be presented at the EuroPCR Congress in May.

April 23, 2012 - CircuLite Inc. announced that updated clinical data related to the Synergy miniature ventricular support system was presented in two oral presentations and one poster session at the International Society for Heart and Lung Transplantation’s 32nd Annual Meeting and Scientific Sessions (ISHLT) in Prague, Czech Republic. The company also announced the successful implantation of the Synergy system in its 51st patient in the ongoing CE mark trial.

April 23, 2012 - Records exposing the level of medical device recalls made in the United States, and therefore the multitude of serious health risks patients have been subjected to over the past few years, have sparked calls for stricter regulations, according to a new report by healthcare intelligence company GBI Research.

April 20, 2012 — VasoStitch will be featuring its technology at EuroPCR, Europe’s largest interventional cardiology scientific meeting, May 17, in Paris.

April 19, 2012 - St. Jude Medical Inc., a global medical device company, announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and the launch of the Trifecta aortic stented, pericardial tissue valve. The first procedures in Japan were performed at Osaka University Hospital and Saitama Medical University International Medical Center.

April 19, 2012 - The FDA received a report from a hospital that 16 patients had developed hospital-acquired infections with the bacteria Pseudomonas aeruginosa following an examination with transesophageal echo (TEE) ultrasound probes using Other-Sonic Generic Ultrasound Transmission Gel. Upon investigation, theultrasound gel was found to be contaminated with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca. Manufactured by Pharmaceutical Innovations Inc., the non-sterile gel is used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.

April 19, 2012 - Phoenix Cardiac Surgery, P.C., of Phoenix and Prescott, Ariz., has agreed to pay the U.S. Department of Health and Human Services (HHS) a $100,000 settlement and take corrective action to implement policies and procedures to safeguard the protected health information of its patients.

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