Abbott announced approvals in Europe for two of its pediatric devices — the Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder. Both devices have received CE Mark and are now available in Europe and other countries that recognize CE Mark. The new treatments, already available in the U.S., offer young pediatric patients and their families hope when no other suitable treatment option may exist.
BioTrace Medical Inc. announced the company’s key activities at the 31st annual Transcatheter Cardiovascular Therapeutics (TCT) conference, which will take place Sept. 25-29, 2019, in San Francisco.
Orchestra BioMed Inc., in partnership with Terumo Corp. announced the company has secured Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Virtue Sirolimus-Eluting Balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease.
Providing exceptional cardiovascular care for patients to achieve the best possible outcomes is the number one goal for ...
The new Max and Debra Ernst Heart Center at Beaumont Hospital, Royal Oak, Mich., will open Sept. 30. It is dedicated to consolidating cardiac care, particularly for patients with heart failure, into a convenient and comprehensive area.
Low-dose aspirin does not prolong disability-free survival of healthy people over 70, even in those at the highest risk of cardiovascular disease. The late-breaking results of the ASPREE trial were presented at the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, Aug. 31-Sept. 4 in Paris. France.
Early use of an implantable cardioverter-defibrillator (ICD) after primary coronary intervention lengthens survival in patients at high risk of death after ST-segment elevation myocardial infarction (STEMI). The late-breaking results from the DAPA trial were presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress 2019, Aug. 31-Sept. 4 in Paris, France, together with the World Congress of Cardiology.
Cardiac positron emission tomography (PET) is growing in popularity among cardiologists because it provides the ability ...
Discharge of patients with suspected acute coronary syndromes under a 0- and 1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol is safe, according to recent research. The late-breaking results from the RAPID-TnT trial were presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress 2019, Aug. 31-Sept. 4 in Paris, France, together with the World Congress of Cardiology and published in Circulation.[1] The trial also found that better strategies are needed to optimize outcomes in patients newly diagnosed with modest troponin elevations.
AstraZeneca announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure. The designation applies to adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).
The European Society of Cardiology (ESC) published new guidelines on the diagnosis and management of chronic coronary syndromes (CCS), which classifies computed tomography angiography (CTA) as a Class 1 recommendation for diagnosing CAD in symptomatic patients. The document, which is a continuation of the 2013 stable coronary artery disease (CAD) guidelines, updates the term to CCS to emphasize the dynamic nature of the disease. It was released at the 2019 ESC Congress, Aug. 31-Sept. 4 in Paris, France, and published simultaneously in the European Heart Journal.
When performing radiofrequency (RF) ablation to treat cardiac arrhythmia, medical professionals must balance the safety ...
The U.S. Food and Drug Administration (FDA) has cleared the Artis icono, a high-precision family of angiography systems from Siemens Healthineers that permit a wide range of minimally invasive procedures to be performed in a single interventional suite. The Artis icono biplane system is engineered for optimal utilization in neuroradiology and abdominal imaging, while the Artis icono floor is a floor-mounted, single-plane system for vascular, interventional cardiology, surgical and oncology procedures. Both systems in the Artis icono family expand the reach of precision medicine.
September 17, 2019 — Treating high-risk heart patients with a single, high dose of radiation therapy can dramatically ...
Rex Medical L.P. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Revolution Peripheral Atherectomy System.
Change Healthcare Cardiology Hemodynamics is an integrated hemodynamic monitoring system for monitoring vital signs and ...
CorWave announced successful completion of its first 60-day preclinical study to evaluate its Neptune left ventricular assist device (LVAD). The results were presented at the 46th Annual Conference of the European Society for Artificial Organs (ESAO), Sept. 8-12 in Hannover, Germany.
Corvia Medical has sponsored and is actively enrolling patients in a heart failure (HF) device trial that, in addition to measuring traditional heart failure endpoints, includes collecting and analyzing biosensor data with physIQ’s continuous remote monitoring platform. The clinical trial is designed to evaluate the clinical efficacy of Corvia’s InterAtrial Shunt Device (IASD) in patients with heart failure and is enrolling patients at more than 100 sites worldwide. Of note, the pivotal Phase 3 study design mirrors commentary within a recent U.S. Food and Drug Administration (FDA) Public Workshop and FDA Draft Guidance for Industry related to using biosensor data.
HeartFlow Inc. has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner, a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention. The HeartFlow Planner will enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies for patients with CAD before each procedure, review cases with colleagues and ensure everyone has a clear picture of the initial treatment plan.