Cardiovascular Ultrasound Analytics Aids Re-accreditation Process 

Accurate reporting is essential to producing the reliable analytics needed to meet lab accreditation standards. This is a process Susan Wayne, RRT, RVT, RCDS, is quite familiar with.

October 27, 2021 — Impulse Dynamics announced the U.S. Food and Drug Administration approved a modification of labeling for the Optimizer Smart medical device, allowing the removal of “normal sinus rhythm” (NSR) from the indications for use statement. Since heart failure patients are no longer required to be in NSR at the time of Optimizer implant, heart rhythm does not impose any restrictions on patients eligible for Optimizer implant, thereby vastly increasing the number of patients who can be treated with CCM therapy.

October 27, 2021 ​​— EBR Systems Inc., developer of the world’s first wireless cardiac pacing system for heart failure, announced the publication of a case report demonstrating its WiSE cardiac resynchonization therapy (CRT) system’s ability to successfully deliver leadless left bundle branch area pacing (LBBAP). 

October 27, 2021 — Teleflex Inc. announced the completion of patient enrollment in a clinical study evaluating the performance of the QuikClot Control+ hemostatic device for mild to moderate (Class I and II) bleeding in cardiac procedures as compared to standard gauze.


Intravascular ultrasound (IVUS) is the workhorse intravascular imaging modality in cardiac cath labs. It is used to help decide the best therapy option, guide pre-stent planning and then confirm and optimize treatment results. This confirmation is mainly determining if a deployed stent is fully apposed to the vessel wall, as exposed stent struts can be a cause of restenosis. 

October 20, 2021 — HeartFlow Inc. announced the commencement of the REVEALPLAQUE (A pRospEctiVe, multicEnter study to AnaLyze PLAQUE using CCTA) trial to evaluate HeartFlow’s non-invasive plaque technology, an automated, deep learning-based method for identifying, characterizing and segmenting plaque in the coronary arteries.

October 20, 2021 — Philips, a global leader in health technology and intravascular ultrasound (IVUS) solutions, announced that a worldwide committee of 40 cross-specialty medical experts achieved the first-ever consensus for the appropriate use of IVUS in peripheral vascular disease (PVD) interventions.

October 20, 2021 — 18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a late-breaking clinical trial at VIVA21.

October 20, 2021 — Boston Scientific Corporation announced positive data for the Eluvia Drug-Eluting Vascular Stent System (Eluvia stent) during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.

October 20, 2021 – CorWave, a French medtech company developing a next-generation heart pump, won the 2021 HealthTech Award in the Medtech category this week for its left ventricular assist device (LVAD) membrane pump technology. Rather than conventional rotary pumps, this LVAD uses electromagnetic pulses to causes a membrane to move up and down, creating pulsatile pumping action more similar to the native heart.

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