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Mashup Score: 0
April 25, 2024 — Provisio Medical announced FDA 510(k) clearance of the Provisio SLT IVUS System. Sonic Lumen Tomography (SLT) technology addresses a critical unmet need for vascular specialists by providing automatic, real-time, accurate, numeric measurements of the flow lumen of blood vessels without the complexities of image interpretation. Provisio Medical’s catheter is the world’s first integrated intravascular imaging and support crossing catheter and enables vessel lumen measurement and visualization simultaneously with guidewire support and delivery of radiopaque contrast agents. It has been demonstrated repeatedly that the current standard-of-care of using angiographic information by itself is insufficient to accurately assess vessel size1 in the approximately 20 million people in the U.S. with peripheral vascular disease2. The use of intravascular imaging has been shown to improve accuracy of vessel sizing and thereby improve clinical outcomes3. By incorporating its technolo
Source: www.dicardiology.comCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 0Atlantic Health System’s Morristown Medical Center Treats First Patient in New Jersey with Edwards’ EVOQUE Tricuspid Valve Replacement - 2 day(s) ago
April 25, 2024 — Atlantic Health System’s Morristown Medical Center treated the first patient in New Jersey using Edwards Lifesciences EVOQUE tricuspid valve replacement, the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR). The EVOQUE system is indicated for improving the health status in patients with symptomatic severe TR despite optimal medical therapy, and for whom tricuspid valve replacement is deemed appropriate by a heart care team. According to National Institutes of Health an estimated 1.6 million people in the U.S. have been diagnosed with TR. “Until now, there was no available transcatheter treatment options for patients with tricuspid valve disease,” said Robert Kipperman, MD, interventional cardiologist and structural heart disease specialist at Gagnon Cardiovascular Institute’s Valve Center at Morristown Medical Center, part of Atlantic Health System. “We are thrilled to have a new t
Source: www.dicardiology.comCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 0
April 24, 2024 — Heart Test Laboratories, Inc. d/b/a HeartSciences, an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that its European Patent Office Application EP3834729 has been granted. Diastolic dysfunction (impaired cardiac relaxation) is a sensitive and crucial indicator of overall heart health, providing one of the earliest signs of heart disease, with onset typically occurring before symptoms. Diastolic dysfunction is caused by all common issues that affect heart function or that produce hypertrophy. All patients with heart disease have diastolic dysfunction, in contrast to systolic dysfunction (reduced pumping of blood by the heart or reduced ejection fraction), which only affects a subset of patients and typically occurs at a more severe, often symptomatic, stage of heart disease. Today, measures of diastolic function of the heart need to be assessed i
Source: www.dicardiology.comCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 0
April 24, 2024 — Expanse ICE announced today the ICE Aspiration System has received 510(k) clearance from the U.S. Food and Drug Administration. This announcement introduces a new and exciting player in the peripheral thrombectomy market. The ICE System is specifically designed to address the complex challenges associated with peripheral thrombectomies. Blood clots are the third most common vascular disease. Almost one million patients suffer from peripheral blood clots that must be treated each year, and up to 33% of them suffer long-term complications, according to the Center for Disease Control. Eitan Konstantino, PhD, a serial entrepreneur in the vascular device field, is the driving force behind Expanse ICE. “We’ve engineered the ICE catheter system to harness the aspiration power typical of a large bore catheter, but within the slender profile of a much smaller device,” Dr. Konstantino said. “It is clear this device was built with physicians in mind. It aims to address some of t
Source: www.dicardiology.comCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 0New Study Reveals 65 and Older Population Lowered Blood Pressure, Cholesterol, and Weight Using Mobile Technology - 2 day(s) ago
April 24, 2024 —Hello Heart, a digital leader in preventive heart health, today announced results from its latest study observing the benefits of scalable, accessible digital health tools for a growing senior population. Presented at the American College of Cardiology 2024 Conference, study results showed an overwhelming majority of seniors aged 65 and over reduced their blood pressure (BP), cholesterol, and weight over a six month period while managing it with a mobile app, highlighting the potential of mobile technology in the prevention and control of cardiovascular disease (CVD) for the aging population. Eighty percent of heart attacks and strokes are preventable. Yet, CVD remains the leading cause of death in the U.S., partially because its key risk factor, high blood pressure, is a ‘silent killer,’ and most patients have no symptoms before their first heart attack or stroke. CVD is especially prevalent in the Medicare-aged population, affecting more than 75 percent of those aged
Source: www.dicardiology.comCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 0Medtronic Launches the Avalus Ultra Valve Engineered for Ease of Use at Implant and Lifetime Patient Management - 4 day(s) ago
April 23, 2024 — Medtronic plc, a global leader in healthcare technology, today announced the launch of its latest innovation in cardiac surgery, the Avalus Ultra valve. This next-generation surgical aortic tissue valve is designed to facilitate ease of use at implant and lifetime patient management. It’s an excellent choice for cardiac surgeons and their patients seeking an aortic valve solution that can be fit for the future, right from the start. The Avalus Ultra valve is engineered for ease of implant, clear visibility for future valve-in-valve procedures, and straightforward sizing. More specifically, the Avalus Ultra surgical valve has: A low valve profile designed to facilitate ease of use at implant.1,2 A polyetheretherketone (PEEK) base frame, which provides consistent circularity3, 4 An industry-leading Effective Orifice Area (EOA) that may allow for greater blood flow that is supported by the clinical evidence of the Avalus™ valve 5,6 A radiopaque coil for clear visibility f
Source: www.dicardiology.comCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 2
April 23, 2024 — A recent study designed and implemented by investigators at Cedars-Sinai found that artificial intelligence (AI) can accurately evaluate cardiovascular risk during a routine chest computed tomography (CT) scan without contrast. This imaging method, which measures coronary calcium and sizes of heart chambers and heart muscle, could make identifying cardiovascular risk less expensive and less invasive. The findings were published in the peer-reviewed journal Nature Communications. A recent study designed and implemented by investigators at Cedars-Sinai found that artificial intelligence (AI) can accurately evaluate cardiovascular risk during a routine chest computed tomography (CT) scan without contrast. This imaging method, which measures coronary calcium and sizes of heart chambers and heart muscle, could make identifying cardiovascular risk less expensive and less invasive. The findings were published in the peer-reviewed journal Nature Communications. “These results
Source: www.dicardiology.comCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 2Novel CT Exam Reduces Need for Invasive Artery Treatment - 5 day(s) ago
April 22, 2024 — A new study showed that a non-invasive imaging test can help identify patients with coronary artery blockage or narrowing who need a revascularization procedure. The findings were published as a Special Report in Radiology: Cardiothoracic Imaging, a journal of the Radiological Society of North America (RSNA). Doctors use coronary CT angiography (CTA) to diagnose narrowed or blocked arteries in the heart. A CTA exam receives a score from mild (0-1) to moderate (2-3) to severe (4-5). Patients with scores above 3 typically require medical treatments and can potentially benefit from stents or surgeries (revascularization) to restore blood flow to the heart. “CTA tells you the degree to which a vessel is blocked,” said Mangun Kaur Randhawa, M.D., a post-doctoral research fellow in the Department of Radiology at Massachusetts General Hospital (MGH) in Boston. “But the degree of blockage doesn’t always reliably predict the amount of blood flow in the vessel.” Doctors have tra
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Mashup Score: 0RCE Technologies, Inc. Announces First-In-Human Transdermal Continuous Cardiac Biomarker Monitoring - 5 day(s) ago
April 22, 2024 — At the annual American College of Cardiology conference (ACC.24) in Atlanta last week, RCE Technologies, Inc., (RCE), an innovative artificial intelligence (AI) based medical technology company dedicated to early heart attack detection, highlighted results of a pilot study enrolling cardiac catheterization patients in the first-ever human trial of transdermal continuous cardiac biomarker monitoring, utilizing RCE’s Infrasensor™ wearable device. Featured in an ACC.24 “Spotlight on Special Topics” presentation showcasing pioneering advancements in cardiac monitoring technology, the study marks a significant milestone in medical innovation. It was spearheaded by Ronald P. Karlsberg, MD, a Fellow of The American College of Cardiology and clinical professor of Medicine at both Cedars-Sinai Institute and UCLA, and led by Suhail Y. Dohad, MD, as principal investigator. Working with 20 consecutive patients encompassing both scheduled diagnostic catheterization procedures and e
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Mashup Score: 1
April 22, 2024 — Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, welcomes the recent release of V-Wave’s RELIEVE-HF trial data supporting the evidence base around atrial shunt therapy, which is currently under study in the global RESPONDER-HF trial of the Corvia Atrial Shunt. RELIEVE-HF failed to meet its primary efficacy endpoint and did not reduce heart failure events or improve quality of life in heart failure patients with a preserved ejection fraction (HFpEF). However, the results confirmed the importance of selecting patients with characteristics likely to benefit from atrial shunting versus those who will not. “Patient selection is critical, especially in HFpEF,” said Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University School of Medicine, and co-Principal Investigator of RESPONDER-HF. “We found in our last trial, REDUCE LAP-HF II, that HFpEF patients with pacemakers or pulmonary vascular disease didn’t benefit from a
Source: www.dicardiology.comCategories: General Medicine News, CardiologistsTweet
@DAICeditor #ProvisioMedical announced #FDA 510(k) clearance of the #ProvisioSLT #IVUS System. https://t.co/naWd6dpgxK