Abbott won clearance in the European Union for its new Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants. The MRI compatible devices, which Abbott claims have an extended battery lifetime, can securely communicate with patients and physicians via Abbott’s myMerlinPulse smartphone app. Physicians can monitor their patients, including being able to […]
Tag: Cardiac Surgery
Novalung FDA Cleared to Provide Long-Term Lung Failure Treatment
Critically ill patients with acute respiratory or cardiopulmonary failure who are on long-term mechanical ventilation too often suffer a variety of side effects. These can include ventilator associated lung injury, pneumonia, and diaphragm dysfunction. Moreover, related sedation and lack of movement can aggravate an already difficult situation. To help address these challenges, the FDA has […]
Artificial Tissue Patches to Heal Damaged Hearts
Post myocardial infarction (heart attack), damaged heart tissue doesn’t tend to heal very well. Not only is the pumping action weakened due to muscle cells dying, but the electrical signaling through the heart can also be impeded. Scientists at Trinity College Dublin have now developed remarkable new patches that mimic the electrical conductivity of heart […]
First AI-Guided Ultrasound Gets Green Light from FDA
Caption Health, a company based outside of San Francisco, CA, won the first authorization from the FDA for an ultrasound software that guides clinicians at capturing images of the heart. The Caption Guidance software should work with any number of ultrasound system from different manufacturers, but currently it can only be used with a diagnostic […]
BIOTRONIK’s Orsiro Mission Drug-Eluting Stent
BIOTRONIK won the European CE Mark for its Orsiro Mission drug-eluting stent. The device is intended for widening coronary arteries at sites of stenotic and in-stent restenotic lesions, and is designed to be delivered through some of the more tortuous vasculature. The device is the next generation of the Orsiro drug-eluting stent and the redesign […]
Textiles from Human Cells for Replacement Vessels, Tissues, Organs
Scientists at University of Bordeaux/French National Institute of Health and Medical Research (Inserm) have developed a completely new biological material, made using human fibroblast cells, that can be turned into sutures, vascular grafts, and many other medical devices and tissue replacements. They showed that their Cell-Assembled extracellular Matrix (CAM) can be turned into yarns of […]
New Customizable Bio-Ink for Printing Organs, Tissues
3D printing of tissues and organs requires a bio-ink that can host the living cells that are required for every unique application. A viable construct requires an extracellular matrix that will have the right mechanical and biochemical properties for the intended cells. Researchers at Rutgers University believe they’re on track to being able to print […]
Wireless Lumee Oxygen Platform Cleared in EU
The European Union cleared Profusa’s Wireless Lumee Oxygen Platform, a system designed to measure tissue oxygen levels in patients with diseases such as peripheral artery disease and critical limb ischemia. The wired version of the Lumee was cleared in Europe back in 2016 and the new device fundamentally works the same. It consists of a […]
Biorobotic Hybrid Heart to Help Develop New Cardiac Implants
Prosthetic heart valves, ventricular assist devices, and other cardiac implants go through an extensive research and development process, followed by testing on animals before human trials. There is no machine that simulates the function of the heart with any sufficient accuracy for comprehensive use by device designers, but researchers at MIT are trying to change […]
EU Clears Medtronic’s Smart Cobalt and Crome Cardiac Implants
Medtronic has announced that its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D) won EU CE Mark clearance, allowing their introduction to the continent. The devices feature Medtronic’s OptiVol fluid status sensors that allow the introduction of the company’s new TriageHF technology. This classifies patients into one of three groups for potential […]
Abbott’s Tendyne First Transcatheter Mitral Valve to Win EU Clearance
Abbott just announced that it is the first company to receive European regulatory approval to introduce transcatheter mitral valve replacement procedures on the continent. The Tendyne Transcatheter Mitral Valve Implantation (TMVI) system is intended for mitral regurgitation patients for whom open-heart surgery is too risky and in cases where transcatheter valve repair is not appropriate. […]
Imricor’s MRI-Compatible Ablation Catheters Cleared in Europe for Cardiac Arrhythmia Treatment
Imricor Medical Systems, based outside of Minneapolis, Minnesota, has won the European CE Mark for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. These devices allow for cardiac ablation procedures to be performed within MRI-equipped operating rooms, thereby utilizing the accuracy of intraoperative MRI to target sources of arrhythmias. The Vision-MR ablation catheter is a […]
Nanoparticles Direct Immune System to Scrub Atherosclerotic Plaques
The buildup of plaques within blood vessel walls is the underlying cause of strokes and heart attacks. These plaques contain many dead or dying cells that are not flushed out by the immune system fast enough. Now, researchers from Stanford are reporting on a new drug-carrying nanoparticle that can seek out atherosclerotic plaques and stimulate […]
Mindray’s New High End Point of Care Ultrasound
Mindray is releasing a new point-of-care ultrasound system, the TE7 ACE. The device, intended for a variety of applications including emergency, critical care, and anesthesia, features a large color touchscreen, fluid management features, needle guidance toolkit, and electronic medical records connectivity. The company claims that the fluid measurement algorithms within this ultrasound are based on […]
Medtronic’s Tiny New Micra AV Pacemaker for AV Block FDA Approved
The FDA has just approved the smallest pacemaker with atrioventricular (AV) synchrony, the Micra AV. The device, intended to treat AV block, a condition typically requiring a dual-chamber pacemaker, is small enough to remain completely inside the heart. It doesn’t have any leads, nor any complications arising from them. It looks the same as Medtronic’s […]
FDA Clears Morph DNA Catheter to Guide Cell Delivery into Heart Tissue
BioCardia, a Silicon Valley firm, won FDA clearance for its Morph DNA catheter, a device developed to help with delivery of the company’s CardiAMP cell therapy into the heart. CardiAMP involves depositing a patient’s own bone marrow cells into heart tissue, with the intention of jump starting the body’s natural healing processes to reverse previous […]
Fully Disposable Endovascular Robot Unveiled
Microbot Medical, a company with offices in Massachusetts and Israel, is about to release the world’s first fully disposable endovascular surgical robot. The LIBERTY device is intended for use in a variety of cardiovascular, neurovascular, and peripheral vascular procedures, manipulating catheters in a fly-by-wire way. Since it can be operated remotely, clinicians can be kept […]
Super-resolution Photoacoustic Microscopy to Find Clogged Blood Vessels
Researchers from Pohang University of Science and Technology in South Korea have developed a new photoacoustic imaging system that can visualize microvasculature without a contrast agent. The new system is 500 times faster than conventional photoacoustic imaging, and features a spatial resolution enhanced by 2.5 times. This system can one day help improve detection and […]
Nanoparticles to Spot Vascular Calcification in Atherosclerosis
Atherosclerosis affects most of us by a certain age, and it is the underlying cause of most cardiovascular diseases. The condition results in arteries being coated with plaques and fatty deposits, as well as being chronically inflamed. While vascular constrictions aren’t good for anyone, it is the thrombi (blood clots) that detach from these formations […]
Exclusive with CELLINK Co-Founders Erik Gatenholm and Dr. Héctor Martínez
CELLINK is a 3D bioprinting company based in Gothenburg, Sweden, and was one of the first companies in the world to offer 3D printable bioink, which is used to print human organs and tissues. In just four years of existence, the company has been able to commercialize products used in more than 700 labs and […]