Abiomed impella, Impella RP, Impella right percutaneous

Abiomed Inc. said the Impella RP (Right Percutaneous) system has received U.S. Food and Drug Administration (FDA) approval under a humanitarian device exemption (HDE). This is the first percutaneous single access heart pump designed for right heart support to receive FDA approval. Abiomed completed the HDE submission for the Impella RP in September 2014 following the completion of the RECOVER RIGHT study.

The U.S. Food and Drug Administration (FDA) has granted approval of Medtronic’s premarket approval application (PMA) for the Melody Transcatheter Pulmonary Valve (TPV) and its Ensemble Transcatheter Valve Delivery System. This allows wider use of the valve in patients born with congenital heart defects that often require multiple open-heart surgeries. The valve is designed to reduce the number of open surgeries and expand the time between them. 

NewYork-Presbyterian Hospital/Columbia University Medical Center is one of a select group of medical centers participating in a clinical trial of a new device for advanced heart failure patients, the Thoratec HeartMate III Left Ventricular Assist System (LVAS).


ECRI Institute has released an updated comparison on cardiac resuscitators used during cardiopulmonary resuscitation (CPR).
HHS, Medicare, payment, fee-for-service, alternative models, business

Health and Human Services Secretary Sylvia M. Burwell announced measurable goals and a timeline to move the Medicare program and the healthcare system at large toward paying providers based on the quality, rather than the quantity of care they give patients. The announcement was made in a meeting with nearly two dozen leaders representing consumers, insurers, providers and business leaders.
3-D printing, tracheal reconstruction, STS, Goldstein, Feinstein Institute

Three-dimensional (3-D) printing can effectively create a biodegradable tracheal segment containing a patient’s own cells for use in complex tracheal reconstruction, according to a proof of concept study abstract released at the 51st Annual Meeting of The Society of Thoracic Surgeons.

CytoSorbents Corporation announced that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to conduct its proposed clinical trial using CytoSorb intra-operatively in patients undergoing complex cardiac surgery requiring the use of a heart-lung machine.

Ortho-Clinical Diagnostics Inc. announced the nationwide availability to hospitals of the Nephrocheck Test System designed to help healthcare providers identify patients at risk of developing moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment.

FEops announced the closing of a €1.3 million (~$1.9 million USD) series A financing round, led by Capricorn Venture Partners and PMV. The funding will be used to support the launch of FEops’ first product, TAVIguide, in key markets in Europe and the United States.

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