The Centers for Medicare & Medicaid Services (CMS) has determined that clinical sites that wish to participate in the newly announced CREST-2 carotid artery stenting (CAS) registry must receive accreditation.


Boston Scientific Corp. has initiated the REPRISE III clinical trial, a pivotal study to evaluate the safety and effectiveness of the Lotus valve system in patients with severe aortic stenosis and who are considered to be at either high or extreme risk for surgical valve replacement.
Claret Medical, Sentinel
Edwards Lifesciences, Embrella
Claret, embolic protection filter for TAVR
Emboline Prosheath

While transcatheter aortic valve replacement (TAVR) is a paradigm shift in how valve disease is treated, one nagging safety issue that remains is TAVR’s stroke rate, which is higher than traditional surgical valve replacements. The solution to this issue may be the use of specialized embolic protection systems, of which four companies displayed their devices on the show floor and in presentations at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in September. 

Singulex Inc. announced the presentation of 10 abstracts at the European Society of Cardiology's (ESC) annual conference, which highlight the clinical utility of single molecule counting technology in the detection and quantification of biomarkers for cardiac disease, its comorbidities, and its risk factors. 

ReFlow Medical Inc. announced the initial clinical use of its Wingman35 Crossing Catheter and speX Shapeable Support Catheter by Dr. Andrej Schmidt at University Leipzig, Germany.

October 1, 2014 — Heart Hospital of Austin is the first facility in Texas to implant a new miniaturized, wireless monitoring sensor to manage heart failure (HF). The CardioMEMS HF system is the first and only U.S. Food and Drug Administration (FDA) -approved HF monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage HF.

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