Transesophageal echo (TEE) being used to guide the deployment of a MitraClip device during a structural heart procedure at the University of Colorado Hospital. The center has performed more than 200 MitraClip mitral valve repairs over the past decade. Photo by Dave Fornell

The resounding success of transcatheter aortic valve replacement (TAVR) has led the creation of hundreds of structural heart programs across the country in recent years. The 2019 decision by the U.S. Food and Drug Administration (FDA) to expand the indication to all patients also fueled the creation of additional programs. Similar success is also expected from transcatheter mitral and tricuspid valve repair and interventions devices in the coming years. It is widely expected there will be a shift in open heart surgical volumes over to these types of minimally invasive cath lab procedures.

April 21, 2021 — EnsiteVascular announced it received its second U.S. Food and Drug Administration (FDA) market clearance for the company’s SiteSeal SV (small vessel) VCD compression device to achieve hemostasis of the brachial artery after a transbrachial endovascular procedure.

As a medical technology journalist, a little more than a decade ago I found myself sitting in those late afternoon "future technology" sessions at the Transcatheter Cardiovascular Therapeutics (TCT) conferences. The sessions sometimes had a sea of open chairs as cardiologist attendees peeled off to get dinner or enjoy visiting the host city after long day. This is where I was introduced to transcatheter valves and the promise the technology might have in the years to come to possibly change how cardiology is practiced. 

April 20, 2021 – The Minneapolis Heart Institute Foundation (MHIF) announced the first publication of outcomes from the North American COVID-19 ST-Segment Elevation Myocardial Infarction (STEMI) Registry (NACMI).

April 20, 2021 — Start-up medical device company atHeart Medical announced it is initiating its U.S. investigational device exemption (IDE) trial for its novel transcatheter reSept atrial septal defect (ASD) occluder. 

April 19, 2021 — Former Vice President Mike Pence is recovering after having a pacemaker successfully implanted to improve a slow heart rate, according to statement from his office released to media outlets April 15. A full recovery is expected. The statement says Pence was diagnosed with asymptomatic left bundle branch block (LBBB).

April 19, 2021 — National Heart, Lung, and Blood Institute (NHLBI) has awarded a grant for $462,689 to Rhythm Therapeutics Inc. (RTI) to complete the phase 1 segment of development of a novel gene therapy to treat atrial fibrillation (AF). It involves using electroporation to create temporary openings in cardiac cells to deliver therapeutic transgenes targeting the underlying molecular mechanisms of AFib.    

April, 14, 2021 – Elixir Medical recently announced the first patient was treated in the BIOADAPTOR randomized controlled trial (RCT) of the DynamX Coronary Bioadaptor System, the first drug-eluting coronary stent that adapts to vessel physiology.

April 14, 2021 — The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical AcQCross family of universal transseptal crossing devices. This is the only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ own suite of sheaths and with sheaths sold by other manufacturers. 

CDC and FDA Call for Pause on Janssen COVID-19 Vaccine Due to Rare Blood Clots #COVID19 #Janssen

(This story was updated May 7, 2021 in the last subheaded section)
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