Contego Medical, based in Raleigh, North Carolina, landed FDA clearance for its Vanguard IEP peripheral balloon angioplasty system. The product features the Congego’s proprietary Integrated Embolic Protection (IEP) technology that captures embolic debris breaking off from occlusions being treated within the superficial femoral artery.&nb (Read more...)
Tag: Cardiology
Canon’s New Alphenix 4D CT and C-Arm System for Interventional Procedures
Canon Medical is releasing a new high end CT scanning and fluoroscopy configuration for use in the interventional suite. The system combines the company’s Alphenix Sky + C-arm, Hybrid Catheterization Tilt/Cradle Table, and the Aquilion ONE / GENESIS Edition CT scanner. The combined system, known as Alphenix 4D CT provides a com (Read more...)
Edwards SAPIEN 3 Ultra Transcatheter Valve for Severe Aortic Stenosis Cleared in Europe
Edwards Lifesciences received European CE Mark approval for its SAPIEN 3 Ultra transcatheter aortic heart valve. Indicated for valve replacement in patients with severe, symptomatic aortic stenosis, the device is available in three sizes (20 mm, 23 mm, and 26 mm) to fit most anatomies. It sports modifications to the valve itself, as well as an (Read more...)
Artificial Intelligence Diagnoses Heart Murmurs Better Than Expert Cardiologists
At the just concluded American Heart Association’s Scientific Sessions 2018 in Chicago, Eko, the makers of popular digital stethoscopes, showed off a neural network AI algorithm that is able to detect murmurs better than a group of cardiologists. The study, titled “Artificial Intelligence Detects Pediatric Heart Murmurs With Cardio (Read more...)
REVA’s Fantom Encore Thin Strut Bioresorbable Scaffold Unveiled
REVA Medical, out of San Diego, California, has released its Fantom Encore bioresorbable scaffold. The implant is made with the company’s own Tyrocore polymer that is absorbed by the body over a period of some months, eventually disappearing while native tissue takes over. The process helps to make sure that the lumen stays open whi (Read more...)
Medtronic’s Valiant Navion Thoracic Stent Graft Cleared in EU
Medtronic won European CE Mark approval to introduce its Valiant Navion thoracic stent graft for treating lesions within the descending thoracic aorta such as thoracic aortic aneurysms (TAA), blunt traumatic aortic injuries (BTAI), and penetrating atherosclerotic ulcers (PAU). The system received FDA approval in October of this year. The Valia (Read more...)
PerQseal Absorbable, Sutureless Large-Bore Closure Device Coming to Europe
Vivasure Medical, a Galway, Ireland company, is launching in Europe its PerQseal closure device for use in large vessel femoral arteriotomies following large-bore transcatheter procedures, such as aortic valve replacements. Though minimally invasive transcatheter procedures have revolutionized cardiovascular care, closing the access sites (Read more...)
Tiny New Pacemaker Small Enough for Infants
Researchers at Children’s National Health System, working with engineers from Medtronic, have created a pacemaker appropriately tiny enough to implant into infants. Measuring only one cubic centimeter, about the size of a large pill, it allows the device to be implanted inside the child in a minimally invasive fashion. Currently, because (Read more...)
Cios Spin Mobile 3D C-Arm for Orthopedic Surgery
Siemens Healthineers has unveiled a new mobile C-arm, the Cios Spin, that can provide both 2D and 3D imaging in just about any operating room. Mostly intended for orthopedic procedures, the device allows clinicians that are currently using 2D C-arms to upgrade to 3D capability and see things in a much more intuitive perspective. Positioning [&helli (Read more...)
Barco’s New 27″ 4K Surgical Monitor
Barco is releasing a new 4K surgical monitor that’s designed to give clinicians a high fidelity live image during interventional procedures. The Barco MDSC-8427 has a 27” screen, providing a new, larger size over common 24″ and 26″ monitors. The display features the company’s smart image processing technology (Read more...)
Smallest Ever Steerable Cardiac Ablation Catheter
Researchers at ETH Zurich and École polytechnique fédérale de Lausanne in Switzerland have developed the thinnest ever steerable cardiac ablation catheter. The device has a magnetic tip, which can be navigated using an external magnetic field with incredible accuracy via a computer. Existing guiding catheters are typically (Read more...)
Optically Pumped Magnetometer to Measure Electric Activity of Fetal Hearts
Assessing the electrical activity of a fetal heart is extremely difficult, since ECG is not an option. Ultrasound is not a substitute for electrical conduction study like ECG, so there’s always a search for a better alternative. Researchers at the University of Copenhagen believe that a new technology they’re working will give clinician (Read more...)
Eko and Mayo Clinic Working on Automated Cardiac Screening Tool
Eko, the company that makes smart electronic stethoscopes that we’re very fond of and which is sponsoring our popular Medgadget 2018 Sci-Fi Writing Contest, has now partnered with the Mayo Clinic to develop automated tools to screen patients for heart conditions. Initially, they’re focusing the attention on spotting low ejection fr (Read more...)
Masimo’s High Accuracy RD SET Pulse Oximeters Cleared by FDA
Masimo won FDA clearance for its RD SET sensors that feature the company’s “Measure-through Motion” and “Low Perfusion SET” pulse oximetry. The new disposable oximeters are supposedly twice as accurate than Masimo’s previous offerings for patients over 3 kg, having an accuracy spec of 1.5% at 1 standard deviation (Read more...)
HoloLens Used to Looks at Heart Scars in High Resolution
At the Beth Israel Deaconess Medical Center in Boston, researchers have been investigating the use of the Microsoft HoloLens augmented reality headset for visualizing myocardial scars during surgical interventions. During ablations and other electrophysiology procedures, the surgeon must have a good idea of where scars and other relevant items are (Read more...)
Near-Infrared Tech for Minimally Invasive Brain Monitoring: Interview with Philippe Dro, CEO of Luciole Medical
Luciole Medical, a medtech company based in Switzerland, has developed near-infrared sensors that can assess levels of tissue oxygenation as well as cerebral blood flow by measuring oxygenated and deoxygenated hemoglobin. The sensors include a skin patch, which measures brain blood flow and oxygen saturation in patients undergoing surgery, and a mi (Read more...)
FDA Approves Valiant Navion Thoracic Stent Graft for Patients with Narrow Iliac Arteries
Medtronic received FDA approval for its Valiant Navion thoracic stent graft, a minimally invasive system for correction of lesions within the descending thoracic aorta, particularly in patients with narrow iliac arteries. The device is indicated in thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries, penetrating atherosclerotic ulc (Read more...)
HeartMate 3 Heart Pump Approved for Patients Not Eligible for Transplant
Abbott‘s HeartMate 3 left ventricular assist device (LVAD) won FDA approval to be used as a destination therapy for advanced heart failure patients who are not eligible for a transplant. Previously, the device has been indicated for patients eligible for and waiting for a transplant. Since transplant hearts are rarely available and not all pa (Read more...)
SnapECG: Medgadget Reviews a Basic ECG Tracing Viewer for Your Phone
mhealth’s SnapECG is a medical-grade handheld single-lead electrocardiograph that connects via Bluetooth to a smartphone. It gives a recording of the heart’s electrical pulses, and stores the data to be given to a doctor later. It has received CE mark in Europe and approval from the Chinese Food and Drug Administration (CFDA). It can be (Read more...)
TSP Crosser for Transseptal Puncture and Left Atrial Navigation Cleared by FDA
Transseptal Solutions, a firm based in Israel, has been given clearance to introduce its flagship TSP Crosser Transseptal Access System in the U.S. The device is used to provide a path and to deliver catheters into the left atrium of the heart. Most minimally invasive cardiology procedures have been performed on the right side of […]