The Medtronic Symplicity Spyral renal denervation catheter in the renal artery, showing how its four electrodes contact the vessel wall for a single RF energy delivery procedure. By ablating the vessel walls, it props the vessel in a fully open position, allowing the kidneys to better filter the blood and remove excess water in hypertension patients. RDN
June 26, 2020
Simplicity Renal Denervation Lowered Blood Pressure Out to 3 Years
June 26, 2020 – New data from the Global SYMPLICITY Registry (GSR) showed that renal denervation (RDN) with the…
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The Foldax Tria surgical valve reimagines the heart valve by incorporating a new, proprietary biopolymer, what the vendor calls LifePolymer, with an innovative valve design intended to eliminate calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants. Tria is also the first heart valve to be robotically manufactured, reducing variability, enabling high precision, repeatability and better quality control.
June 23, 2020
Foldax Gets $20 Million to Finance Innovative Heart Valve Technology
June 23, 2020 – Heart valve start-up Foldax is looking to reinventing several aspects of the prosthetic heart valve,…
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Bystanders using a Philips HeartStart AED for a patient in sudden cardiac arrest.
June 23, 2020
FDA Grants Premarket Clearance for Philips HeartStart FR3 and HeartStart FRx Automated Defibrillators
June 23, 2020 — Philips announced the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for…
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Navin Kapur, M.D., Tufts Medical Center, shows preCardia device and its anatomical positioning in the patient to treat heart failure..
June 23, 2020
FDA Grants Breakthrough Device Designation for preCardia Catheter-based Heart Failure Treatment
June 23, 2020 — The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Program status for the…
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SMT Enters Structural Heart Market With Acquisition of Vascular Concepts. The company's Hydra TAVR (TAVI) valve gained European CE mark clearance in June 2020.
June 19, 2020
SMT Enters Structural Heart Market With Acquisition of Vascular Concepts
June 19, 2020 — SMT (Sahajanand Medical Technologies Pvt. Ltd) said it acquired of the structural heart medical device…
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iVascular Launches Essential Pro Coronary Drug-coated Balloon
June 19, 2020
iVascular Launches Essential Pro Coronary Drug-coated Balloon
June 19, 2020 — iVascular SLU announced the global launch of Essential Pro, a novel coronary artery drug-coated balloon…
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MedAlliance announced its second CE mark approval for its Selution SLR 0.014 percutaneous transluminal coronary angioplasty (PTCA) sirolimus drug-eluting balloon (DEB) for the treatment of coronary artery disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad range of balloon sizes, from 1.5 x 10 mm, up to 5 x 40 mm.
June 18, 2020
MedAlliance Sirolimus Drug Eluting Balloon Gains Second European CE Mark
June 17, 2020 — MedAlliance announced its second CE mark approval for its Selution SLR 0.014 percutaneous transluminal…
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he 36-month results from Veryan Medical’s MIMICS-2 study for the BioMimics 3D femoropopliteal stent showed low rates of revascularization and compared very favorably to current standards of care.  The results were presented by Professor Thomas Zeller, M.D., University Heart Centre Freiburg, Bad Krozingen, Germany at the CX 2020 Live conference.   
June 16, 2020
Excellent 3-year Results in MIMICS-2 Study of the BioMimics 3D Vascular Stent 
June 16, 2020 — The 36-month results from Veryan Medical’s MIMICS-2 study for the BioMimics 3D femoropopliteal stent…
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Biotronik Launchs His-Bundle Pacing Tools
June 16, 2020
Biotronik Launches His-Bundle Pacing Tools
June 16, 2020 - Biotronik has today announced its commitment to giving physicians additional tools to pace in the His-…
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Health Canada and the U.S. Food and Drug Administration (FDA) approved Thermedical’s degassed saline for use with its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate catheter, currently being studied for the treatment of ventricular tachycardia (VT), a leading cause of sudden cardiac death worldwide.
June 16, 2020
FDA and Health Canada Approve Thermedical’s Degassed Saline to Help Reduce Risk of Stroke
June 16, 2020 – The Montreal Heart Institute (MHI) and Thermedical, a developer of thermal-ablation systems to treat…
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The FDA has determined chloroquine and hydroxychloroquine are not effective at treating novel coronavirus and revoked its earlier emergency use authorization (EUA) for the drugs to be used in COVID-19 patients. FDA says hydroxychloroquine does not work to treat COVID-19.Getty Images #COVID19 #COVID19update #SARSCoV2
Dave Fornell, Editor
June 15, 2020
FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine for COVID-19
June 15, 2020 — The U.S. Food and Drug Administration (FDA) today revoked the emergency use authorization (EUA) that…
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At Mayo, they have a small, tableside-mounted ultrasound console in the cath labs that is used for both radial and femoral vascular access. Table set up with the patient includes a sterile marker, a hemostat for marking the lower edge of the femoral head using fluoroscopy, a micropunture needle, and a still micropunture sheath.
Dave Fornell, Editor
June 10, 2020
Use of Ultrasound to Improve Vascular Access
Vascular access site bleeding is associated with higher complications and mortality rates. For decades femoral access…
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A PCR genetic test nasal swab being taken from a patient to test if they are infected with COVID-19. While used as the primary test to diagnose coronavirus, up to 20 percent of patients will test negative even eight days after infection. Getty Images
June 10, 2020
COVID-19 Genetic PCR Tests Give False Negative Results if Used Too Early
June 10, 2020 — In a new study, Johns Hopkins researchers found that testing people for SARS-CoV-2 (COVID-19) too early…
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SMT (Sahajanand Medical Technology Private Ltd.), a leading medical device company of India focused on cardiology, announced it Hydra transcatheter aortic valve replacement (TAVR) device received European CE mark approval. It is indicated for the treatment of patients diagnosed with aortic stenosis. #SMT #HYDRA #TAVR
June 09, 2020
SMT Hydra TAVR System Receives European CE Mark Approval
June 9, 2020 — SMT (Sahajanand Medical Technology Private Ltd.), a leading medical device company in India focused on…
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Two examples of CT myocardial perfusion (CTP) imaging assessment software. Canon is on the left and GE Healthcare is on the right. Both of these technologies have been around for a few years, but there have been an increasing amount of clinical data from studies showing the accuracy of the technology compared to nuclear imaging, the current stand of care for myocardial perfusion imaging, and cardiac MRI.
Dave Fornell, Editor
June 08, 2020
New Technologies Take Cardiac CT to the Next Level
Here is an overview of a few of the biggest technology advances in cardiovascular computed tomography (CT). These are…
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June 08, 2020
Edwards Sapien 3 Transcatheter Heart Valve Receives Approval In China
June 8, 2020 — Edwards Lifesciences Corp. announced Chinese regulatory approval for the Edwards Sapien 3 transcatheter…
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BD (Becton, Dickinson and Company, and Bard) launched the Halo One Thin-Walled Guiding Sheath, designed to perform as both a guiding sheath and an introducer sheath, for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices.
June 08, 2020
BD Launches of Halo One Thin-Walled Guiding Sheath
June 8, 2020 – BD (Becton, Dickinson and Company) launched the Halo One Thin-Walled Guiding Sheath, designed to perform…
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Russian interventional cardiologist Alexey Pankov in full personal protective equipment (PPE) for a cath lab procedure in Moscow during the COVID-19 era. Right, an image of the COVID-19 virus from the National Institutes of Health (NIH).
Dave Fornell, Editor
June 05, 2020
The Cardiovascular Impact of COVID-19
It was originally thought novel coronavirus (COVID-19, SARS-CoV-2) was primarily a respiratory disorder, but as larger…
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Abiomed announced the U.S. Food and Drug Administration (FDA) has approved the company's investigational device exemption (IDE) application to start an early feasibility study with a first-in-human trial of the 9 French (Fr) Impella ECP heart pump. Impella ECP, which stands for "expandable cardiac power," will be studied in high-risk percutaneous coronary intervention (PCI) patients.
June 05, 2020
FDA Approves First-in-Human Trial of Impella ECP World’s Smallest Heart Pump
June 5, 2020 — Abiomed announced the U.S. Food and Drug Administration (FDA) has approved the company's investigational…
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A Philips Healthcare transesophageal echocardiography (TEE) system in use in a hybrid OR.
June 04, 2020
New Guideline Outlines Use of Transesophageal Echo to Assist Surgical Decision-making
June 4, 2020 — Intra-operative transesophageal echocardiography (TEE) is a versatile diagnostic and monitoring tool…
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