heart valve repair medtronic corevalve evolut recapturable

Medtronic Inc. announced the first implants in the CoreValve Evolut R clinical study, which will evaluate the safety and effectiveness of the CoreValve Evolut R recapturable system. This recapture-enabled valve and delivery system is designed to advance deliverability and valve performance while providing the option to recapture and reposition the CoreValve Evolut R valve during deployment, if needed, while performing transcatheter aortic valve implantation (TAVI).

Nuclear Imaging Services LLC (NIS) has completed the first U.S.-based ECAT Scintron installation into an outpatient cardiology facility. Gulf Coast Cardiology Group in Port Arthur, Texas, is the first to upgrade its Siemens ECAT system to Medical Imaging Electronics' (MiE) ECAT Scintron.

Epsilon Imaging Inc., a visualization and analysis software provider, announced the launch of its newest application specifically designed for right ventricle (RV) assessment. EchoInsight computer-aided visualization and analysis offers quick and intuitive strain imaging along with automated cardiac function measurements for enhanced confidence and workflow in echo interpretation.

By Dave Fornell, DAIC Editor

The Cardiovascular Research Foundation’s (CRF) Transcatheter Cardiovascular Therapeutics (TCT) 2013 scientific symposium Oct. 27 – Nov. 1 in San Francisco is celebrating its 25th anniversary. The event has grown from a couple hundred attendees its first year to more than 12,000 attendees expected this year. TCT has grown from a small niche meeting focused on angioplasty to an international gathering that encompasses the entire spectrum of emerging catheter-based technologies and techniques.

Pie Medical Imaging B.V. (PMI) announced that they have signed an agreement with the Cardiovascular Research Foundation (CRF) to begin a close collaboration. Under this agreement, the CRF Clinical Trials Center will use PMI’s solutions in their Angiographic Core Laboratory for clinical research and multicenter trials. CRF will also support further development of PMI’s new products for analysis and visualization of medical images.

Medtronic Inc. announced the U.S. launch of the Export Advance aspiration catheter, a U.S. Food and Drug Administration (FDA)-cleared catheter that features a pre-loaded stylet that increases deliverability and kink resistance while traversing the vasculature to reach the aspiration site.

Bard Peripheral Vascular has sent an urgent Class I medical device recall notification letter informing customers of the problems of the LifeStent Solo vascular stent and the actions customers should take. The LifeStent Solo vascular stent is an implantable self-expanding stent and delivery system used to improve the superficial femoral artery (SFA) luminal diameter in the treatment of atherosclerotic lesions.

Amplatzer, St. Jude Medical, ASD closure

The U.S. Food and Drug Administration (FDA) issued a warning this week about safety issues encountered with the St. Jude Amplatzer Atrial Septal Occluder (ASO), a transcatheter device used to seal congenital holes in the atrial septum. The FDA reported in a rare safety communication that the device may cause life-threatening tissue erosion inside the heart.
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