Accumetrics Inc. announced that its next generation VerifyNow II System has achieved CE marking for point-of-care measurement of platelet reactivity to antiplatelet agents. This marks the culmination of a series of important milestones in 2012, increasing evidence of the clinical value of platelet reactivity testing and significantly expanding the market opportunities for the VerifyNow System in both surgical and interventional cardiology patient populations.

Biotronik announced that the European Heart Journal has published the clinical results of the ECOST trial (Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology). The randomized controlled study evaluated the safety and efficacy of Biotronik Home Monitoring compared with standard in-office follow-up visits for patients with implantable cardioverter-defibrillators (ICDs).

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.

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