July 10, 2014 — 480 Biomedical announced it has been awarded Phase II funding from the National Heart, Lung, and Blood Institute (NHLBI) to continue the development of a bioresorbable, self-expanding scaffold to treat pediatric pulmonary artery stenosis (PAS).

July 10, 2014 — Life Recovery Systems announced the U.S. Food and Drug Administration (FDA) has approved two investigational device exemptions (IDEs) to study the use of the ThermoSuit system in the treatment of heart attack and ischemic stroke. Patients in both trials will be cooled while under sedation, with the intent of reaching a state of therapeutic hypothermia in approximately 30 minutes or less.

Orlando Heart Specialists (OHS) has added an 8th location in southwest Orlando, Fla. 

Biotronik announced that the first device patients to undergo full-body magnetic resonance imaging (MRI) scans in the United States have been implanted with the Biotronik DX System. 


This August marks the 100th anniversary of the start of World War I in 1914. A few months after the start of the war, in early 1915, the Germans began using Zeppelins in the first application of strategic bombing over British cities. Zeppelin raids continued over Russia, Belgium, France, Italy and Britain for the duration of the war. These raids ironically paved the way for U.S. government policy that guaranteed access to the cryogenic gas required to operate today’s magnetic resonance imaging (MRI) systems. 

In the current era of healthcare reform with the overarching goal of reducing healthcare costs, heart failure (HF) management has taken center stage. It is the leading cause of hospitalization for adults over the age of 65 in the United States and accounts for more than 1 million hospitalizations annually, with Medicare expenditures of more than $17 billion.[1,2] It is apparent that current HF monitoring efforts are not adequate, which has led to great interest in more effective technologies. 

A big fly in the ointment for widespread adoption of many new technologies is cost. In today’s cost-conscience environment of healthcare reform, there needs to be a clear, quantifiable return of investment (ROI). This is especially true for new medical technologies that are competing with a long-established standard of care, where the new technology must show either a cost-benefit over the older technology, or must show a big improvement in patient outcomes to justify the added expense.

A big fly in the ointment for widespread adoption of many new technologies is cost. In today’s cost-conscience environment of healthcare reform, there needs to be a clear, quantifiable return of investment (ROI).

Mr. KH is a 58-year-old male with a past medical history of hypertension and tobacco abuse who presented to the  emergency department (ED) with an episode of syncope. The patient stated that he was at home walking to the kitchen when he felt light-headed and then woke up on the floor. The event was witnessed by his wife, and he was not noted to have any seizure-like activity. On arrival in the ED, the patient began to complain of chest discomfort and dyspnea. A stat electrocardiogram (ECG) revealed sinus rhythm and 2 mm ST-segment depression in leads V4-V6. The patient lost consciousness while in the ED and was emergently intubated. His blood pressure was 65/45, and he was started on intravenous phenylephrine, dopamine and norepinephrine to maintain a blood pressure of 70/40. The patient was taken emergently to the cardiac catheterization laboratory (CCL) where an intra-aortic balloon pump (IABP), was emergently placed. Coronary angiography revealed mild atherosclerotic disease and the aortic valve could not be crossed. 

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