April 26, 2012 — Interventional cardiologists can and should lead efforts to improve quality, cut costs and ensure appropriate use of procedures. Elliott Fisher, M.D., MPH, professor of medicine at Dartmouth, an internationally recognized expert on variations in health system performance and one of the originators of the concept of accountable care organizations, will challenge the interventional cardiology community to accomplish these and other goals at a town hall meeting during the 2012 Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI) in Las Vegas. His keynote address, “Why Interventional Cardiology Needs to be a Change Leader,” will set the stage for an interactive discussion with cardiologists attending the conference.

April 24, 2012—Providing more guidance to clinicians on the provision of optimal patient care, the American College of Cardiology Foundation (ACCF), American Heart Association (AHA) and American Medical Association–convened Physician Consortium for Performance Improvement (AMA-PCPI) released a publication highlighting updated performance measures for adults with heart failure (HF). The 2011 performance measures include care provided in both the outpatient and inpatient setting, emphasizing the need to measure care quality over time and across providers, while also focusing on patient outcomes.

April 24, 2012 - SeptRx, an emerging medical device company that has developed the SeptRx Intrapocket PFO Occluder (IPO) — a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO) — reported that it has completed enrollment for its “InterSEPT” (In-tunnel SeptRx European PFO Trial) clinical trial in Europe, and has entered into a partnership with CoRRect Medical GmbH for commercial distribution in Germany and Switzerland of the SeptRx IPO.

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 - 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 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 - 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.