Last month, Medtronic announced receipt of U.S. Food and Drug Administration (FDA) approval for and launch of the Evolut Pro+ TAVR (Transcatheter Aortic Valve Replacement) System to treat patients with symptomatic severe aortic stenosis. Aortic stenosis is characterized by stiff, often thickened aortic valve leaflets that struggle to open and close (Read more...)
Tag: Cardiac Surgery
FDA Clears geko Muscle Pump Activator to Prevent VTE
Venous thromboembolism (VTE) too often strikes bedridden patients in the hospital, and this is one of the main reasons that patients are put back on their feet as soon as possible. Inflatable wraps placed around the legs, which can raise the pressure, are a common way to prevent the condition. Now, a device called geko […]
Low Power MRI Helps Image Lungs, Brings Costs Down
Modern clinical MRIs usually have magnetic field strengths of 1.5 or 3.0 Tesla. These are pretty powerful magnets and it’s the reason that these devices are very expensive. While such strengths have been standard for a long time, the internal hardware and software beyond the magnets have been improving steadily. Now, researchers affiliated wi (Read more...)
Gore CARDIOFORM ASD Cleared in Europe for Atrial Septal Defects
Gore won the European CE Mark for its GORE CARDIOFORM ASD Occluder, a device designed for percutaneous, transcatheter closure of ostium secundum atrial defects (ASDs). The occluder recently completed a clinical study involving 125 patients with ASD, ranging from 2 to 84 years of age, all of whom were successfully implanted with the GORE CARDIOFORM (Read more...)
Laser Activated Gold Nanorods Create Silk Seal for Incisions and Wounds
Staples and sutures are currently used to seal soft tissues together in clinical practice, but researchers at Arizona State University have come up with an alternative technique that resembles welding. It may end up being used to seal tissues during surgeries and to treat wounds, and in many cases simply to enhance the effectiveness of […]
Apps for Healthcare Monitoring: Interview with Artem Petrov, CEO of Reinvently
Reinvently, a mobile app development company based in Palo Alto, California, has created a number of healthcare apps, including those which collect, collate, and display data from wearable medical devices. The combination of a wearable device and a mobile app allows clinicians to monitor their patients in real-time and identify issues before they b (Read more...)
Hydrogel Mimics of Heart Tissue to Study Cardiac Reshaping Following Aortic Valve Implantation
Transcatheter aortic valve replacement (TAVR) procedures have become a popular way of treating aortic valve stenosis, a condition in which the valve stiffens and worsens cardiac function. Following implantation of a prosthetic valve, the hearts of patients tend to undergo significant reconstruction around the treatment site, but the mechanics of th (Read more...)
Early Bird, an Internal Bleeding Detector, Now Available In U.S.
Saranas, a Houston, Texas firm, is releasing its novel Early Bird bleeding monitoring system in the United States, following FDA de novo approval of the device. Intended for use during minimally invasive vascular procedures, the Early Bird helps to identify dangerous events such as ruptured or dissected vessels. Such incidents can result from using (Read more...)
Material to Repair Cardiac Tissue Damaged by Heart Attacks Passes First Clinical Trial
Ventrix, a spin-off company of the University of California San Diego, has developed a special hydrogel that can be injected into the heart to provide a platform for cardiac repair following a heart attack. The technology was just tested in humans for the first time as part of an FDA-approved Phase 1 clinical trial. Though […]
FDA Clears Siemens Artis icono Angiography Systems
Siemens Healthineers won FDA clearance for the ARTIS icono angiography systems that are designed for use in a variety of procedure types. The ARTIS icono 2D/3D biplane system is intended for neuroradiology and abdominal imaging while the ARTIS icono floor has a single fluoroscope and is designed for vascular, interventional cardiology, surgical, an (Read more...)
Injectable Hydrogel for Transcatheter Intravascular Embolization: Interview with Dr. Rahmi Oklu, Founder of Obsidio
Obsidio Inc., a medical device company based in Columbia, South Carolina, has developed an embolic hydrogel (called a gel embolic material: GEM) designed to be delivered minimally invasively through a clinical catheter for blood vessel occlusion. Applications include controlling blood flow in vascular injuries and aneurysms, reducing tumor blood su (Read more...)
Tivus Ultrasound System for Pulmonary Arterial Hypertension Gets FDA Breakthrough Designation
SoniVie, a company based in Israel, won FDA Breakthrough Device Designation for its TIVUS intravascular ultrasound system for patients suffering from pulmonary arterial hypertension (PAH). Currently there are only medications available for PAH and even those don’t do so well at improving mortality rates, so the new designation is potentially (Read more...)
Nanovolcanoes Record Electrical Activity Inside Heart Cells
The electrical activity of cardiomyocytes and other excitable cells such as neurons is studied using a number of techniques. To get details about the action potentials within the interior of the cell requires either forcefully pushing microelectrodes through the cellular barrier or using electroporation, a high voltage technique that makes temporar (Read more...)
Edwards ForeSight Brain Oxygenation Sensors FDA Cleared to Pair with Hemosphere Monitor
Edwards Lifesciences won FDA clearance to integrate its ForeSight brain tissue oxymetry sensors with the HemoSphere monitoring platform. While the clearance is really for a connecting cable, the capability allows anesthesiologists to monitor the oxygen saturation of the brain during surgeries and to correlate it with hemodynamic parameters in real- (Read more...)
Barostim Neo Neuromodulation Device for Heart Failure Wins FDA Approval
CVRx, a Minneapolis, Minnesota company, won FDA approval for the first neuromodulation device designed to address heart failure. Intended as a treatment option for patients with an ejection fraction ≤35% and New York Heart Failure Classification of III or II (with recent history of Class III), the device stimulates the carotid artery and in turn (Read more...)
Nexus Ultrasonic Surgical Platform from Misonix Cleared in Europe
Mixonix, a Farmingdale, New York company that focuses on ultrasonic devices for surgical applications, including osteotomies and debridements, landed European CE Mark approval for its Nexus surgical platform. The system was FDA cleared earlier this year. The Nexus combines the capabilities of Mixonix’s three existing products, namely BoneScal (Read more...)
Adult Human Heart Tissue Grown Using Biowire II Platform
TARA Biosystems, a firm based in New York City, and GlaxoSmithKline have managed to grow adult cardiac tissue inside the Biowire II platform developed by TARA, and have used this live tissue as a test bed for cardiac drug research. Previously, growing cardiac tissue from human induced pluripotent stem cells that can be used in […]
Carbon Nanotube Fibers as Electrical Bridges for Damaged Heart Tissue
Damaged heart tissue, as a result of a myocardial infarct, is not only a problem because it weakens overall cardiac function but also because it no longer conducts electricity well enough to effectively propagate the heart’s signals. Arrhythmias are a common result of this, and although there are drugs that can help some patients, the [&helli (Read more...)
Biomaterial Tricks Immune System to Grow New Blood Vessels
Researchers from Harvard’s Wyss Institute have developed a new biomaterial that can activate T cells to promote vascularization of ischemic tissues. Their work demonstrates that the biomaterial results in local blood vessel development, increased perfusion, and new muscle growth after ischemia. Various compounds have been tested to try to imp (Read more...)
Magnetically Controlled Soft Robots to Operate on Human Body
Although a myriad of robots is already used in a variety of industries, including medicine, they’re almost exclusively rigid devices using conventional mechanics. To best work with the pliability of the human body, it may be advantageous for medical robots to be soft and not include gears, motors, and metal cables. Researchers at North Caroli (Read more...)