January 3, 2013 — Cardiovascular Systems Inc. (CSI) announced it has completed enrollment in its ORBIT II clinical trial, enrolling 443 patients. ORBIT II is evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating severely calcified coronary arteries.

January 3, 2013 — BioVentrix announced it has received CE mark for its Revivent myocardial anchoring system, which makes possible Less Invasive Ventricular Enhancement (LIVE), a procedure that restores the left ventricle from damage done by a heart attack to a more optimal volume and conical shape.

Miracor Medical Systems GmbH announced that its PICSO system was used for the first time under CE mark in the United Kingdom to treat a patient with a large acute heart attack, or ST-segment elevation myocardial infarction (STEMI). Interventional cardiologist Dr. Magdi El-Omar performed the PICSO procedure in Manchester, England.

Tensys Medical Inc has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the TL-300, the company’s latest generation system. The TL-300 is a member of Tensys’ established T-Line family, which has successfully been used by over 50,000 patients since commercial launch. The T-Line technology accurately and continuously captures a patient’s beat-to-beat waveform and blood pressure in a completely noninvasive fashion, providing physicians with a stream of real-time hemodynamic data that is not possible using traditional noninvasive blood pressure (cuff) devices. Avoiding the blind-time associated with a deflated or inaccurate cuff can enhance hemodynamic monitoring, which has been definitively linked to improved clinical outcomes.

The Society of Cardiovascular Computed Tomography (SCCT) announced the publication of the SCCT Expert Consensus Document on Computed Tomography Imaging Before Transcatheter Aortic Valve Implantation (TAVI)/Transcatheter Aortic Valve Replacement (TAVR) in the Journal of Cardiovascular Computed Tomography (JCCT).

CathPCI Registry Interventional Cardiology Data Cath Lab JACC

A report from the CathPCI Registry, a data registry that includes information from 85 percent of the heart catheterization laboratories in the United States, is providing a vivid snapshot of the current practice of invasive cardiology.
abbott Xience Xpedition stent

Abbott announced that the Xience Xpedition everolimus-eluting coronary stent system received U.S. Food and Drug Administration (FDA) approval and is launching immediately in the United States, providing physicians with a next-generation technology with the largest size matrix in the U.S. market.
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