January 26, 2021 — Pedra Technology, a privately held company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the periprocedural use of its Pedra Xauron Perfusion System in the treatment of critical limb threatening ischemia (CLTI).

January 26, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Boston Scientific's Synergy Megatron Drug-Eluting Stent (DES) system. The company said it is the first platform that is purpose-built for large, proximal vessels.

January 25, 2021 — The U.S. Food and Drug Administration (FDA) approved Merck's Verquvo (vericiguat). It is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics. 

Joint Interventional Meeting (JIM)

An example of 3-D computer aided design (CAD) software from Materialise being used at Henry Ford Hospital to evaluate left ventricular outflow tract (LVOT) obstruction from a Sapian TAVR valve virtually implanted in the mitral valve position. Henry Ford uses both 3-D printing and CAD to plan and guide complex structural heart procedures. 

With increasing complexity of interventional structural heart disease and congenital heart disease interventions, 3-D printing of the anatomy is being used for pre-planning and practicing procedures, device sizing and as a visual reference for the soft tissue during procedures. 3-D printing has become more popular within the medical space as it has been shown to help prevent, fix and foresee procedural errors.
Cardiologists are taking a closer look at the possible long-term cardiovascular effects on COVID long-hauler patients who still show symptoms long after they should be recovered from the virus. Getty Images

With nearly a year of experience with the COVID-19 (SARS-CoV-2) virus, it has been found that some post-COVID patients experience long-term lingering coughs, cognitive issues and other complains months after they recover from the virus. These long-haulers are also appear to be having the heart issues as well. Determining the long-term impact of coronavirus will certainly be one of the top cardiology issues discussed in 2021.

As of January 2021, in the United States we are now on month 10 of the COVID-19 pandemic. One year ago, we followed events unfolding in China. One of the first takeaways from the Chinese experience was that this virus was different than the flu were the reports of multiple manifestations of the COVID, including a significant cardiovascular impact in sicker patients.

HeartSciences has been developing a new type of ECG system called Wavelet ECG that may offer a new way of looking at the heart. The MyoVista system uses continuous wavelet transform (CWT) signal processing to provide new frequency and energy information to detect cardiac relaxation abnormalities associated with left ventricular diastolic dysfunction commonly associated with hypertension, diabetes, valvular disease, ischemia, and reduced systolic function. Artificial intelligence is used to read the exam.

Here are a few trends to watch for in electrocardiogram (ECG, or if you prefer the original German EKG) systems. The biggest advancement in ECG systems in recent years has been the movement to greater interoperability and digital formats. But other technologies are beginning to be integrated into ECG systems, such as aids to properly place leads, artificial intelligence and a ways to extract additional information from ECGs to increase diagnostic value.

Here are some trends in these newer ECG systems:

January 20, 2021 — The U.S. Centers for Medicare and Medicaid Services (CMS) revised its National Coverage Determination (NCD) to expand coverage for the Abbott MitraClip to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure.

The procedure is known as transcatheter edge-to-edge repair (TEER), but is also referred to as transcatheter mitral valve repair (TMVR).

More complex, longer interventional procedures such as structural heart interventions or this revascularization of a coronary chronic total occlusion (CTO) at Henry Ford Hospital in Detroit, requires angiography imaging systems that have improved image detail and lower radiation dose. However, purchase of new systems was put on hold by many hospitals in 2020 due to the sudden drop in elective procedures and diversion of resources due to the COVID-19. Photo by Dave Fornell. Interventional X-ray market.

January 19, 2021 – With the postponement of non-essential elective surgeries and medical procedures in 2020 to conserve medical resources for COVID-19 patients during the start of the pandemic, cardiovascular procedures were severely impacted. The increased costs of caring for COVID patients, personal protective equipment (PPE) and the loss of elective procedure revenue caused a massive financial burden on healthcare providers.
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