Edwards Lifesciences (Irvine, California) investors seemed to breathe a collective sigh of relief Monday afternoon when the company released data at the Society of Thoracic Surgeons (STS; Chicago) that restored confidence in the transapical approach (TA) for delivering the company's Sapien transcatheter heart valve to high-risk surgical patients with severe aortic stenosis. These patients were treated during the continued access period (CAP) of Cohort A of the PARTNER trial.
Nearly every day at MDD we report on the latest advances in health IT, one of the fastest growing sectors in the industry. It seems like new HIT and systems-related companies are cropping up every week, promising to enhance communication between patients and providers, and improve clinical workflow. But what happens when this technology fails – and trust me, it will – and the people trained to use these fancy pants systems are not taught how to go back to the basics, a.k.a. the pen-and-paper method? Let me give you an example from my own recent experience with the military’s...
A company known to use the slogan "see what you ablate, ablate what you see" at tradeshows has made large strides lately towards enabling electrophysiologists to do just that. The company has developed an atrial fibrillation catheter ablation system that incorporates, for the first time, an endoscope for direct visualization of a beating heart, in real-time and without radiation.
St. Jude Medical (St. Paul, Minnesota) reported that an interim analysis of its FAME II trial has found highly statistically significant reduction in the need for hospital readmission and urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease.
Covidien (Mansfield, Massachusetts) is recalling all production lots for its Duet TRS Universal Straight and Articulating single use loading units (SULUs), with respect to the use of the products in the thoracic cavity. The company is calling it a voluntary recall, however Covidien says it has received reports of 13 serious injuries and three patient deaths following the application of Duet TRS in the thoracic cavity.
