The DEFLECT III (A prospective randomised evaluation of the TriGuard embolic deflection device during transcatheter aortic valve replacement) trial, which Alexandra Lansky (Yale University School of Medicine, New Haven, USA) presented at the 2015 American College of Cardiology Annual Scientific Session (14–16 March, San Diego, USA), indicates that use of the cerebral protection device TriGuard (Keystone Heart) in patients undergoing transcatheter aortic valve implantation (TAVI) is associated with an increase in the proportion of patients free from ischaemic brain lesions. This is the first study of cerebral protection to have this finding.
Royal Philips has launched IntelliSpace Cardiovascular, a web-enabled image and information management system with a single integrated workspace that produces a holistic view of the patient’s care continuum across the entire cardiovascular service line. The new solution provides cardiologists with sophisticated tools for diagnosis and planning of patient cardiovascular care.
St Jude Medical has announced a new data analysis from the CHAMPION trial showing that heart failure patients with reduced ejection fraction on optimal doses of guideline directed medical therapy managed by pulmonary artery pressure monitoring with the CardioMEMS heart failure system had a 57% reduction in mortality and a 43% reduction in heart failure hospitalisations compared with patients on guideline directed medical therapy managed by the standard of care. These data show a strong improvement for patients managed by optimal guideline directed medical therapy and the CardioMEMS system in both mortality and hospitalisations over currently defined best practices.
AstraZeneca has announced full results from the PEGASUS-TIMI 54 study, a large-scale outcomes trial that investigated Brilinta (ticagrelor) tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrolment.
Medtronic unveiled the preclinical outcomes of its novel Drug-Filled Stent at the 64th Annual Scientific Session of the American College of Cardiology (14–16 March, San Diego, USA). The preclinical data showed controlled and efficacious drug elution into the arterial wall without a polymer carrier, while reducing diameter stenosis and achieving complete stent coverage quickly without inflammation. Based on these results, Medtronic plans to initiate a clinical trial in the coming months.
Medtronic has unveiled new two-year data from the high risk study of the CoreValve US pivotal trial, which continued to show superior survival benefit at two years for transcatheter aortic valve replacement (TAVR) with the CoreValve system compared to patients who underwent surgical aortic valve replacement (SAVR). Medtronic says that this is the first and only head-to-head study to show statistically significant survival differences favouring TAVR in aortic stenosis patients who are considered high risk for surgery.
Boston Scientific has received US Food and Drug Administration (FDA) approval for the Watchman left atrial appendage closure device. The Watchman device offers a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. The device will be made available to US centres involved in Boston Scientific clinical studies and additional, specialised centres as physicians are trained on the implant procedure.
A new study published in Stem Cells Translational Medicine demonstrates how mesenchymal stem cells (MSCs) not only protect the heart from further damage after a cardiac incident but can also slow down its ageing process. These findings, in a rat model of the ageing heart, could help propel stem cells to the fore as a potential solution for more effective ways to treat heart conditions.
The Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF), a non-profit association headquartered in Washington, DC, USA, has been launched to generate awareness of the potential serious health risks, including cancer and career-threatening orthopaedic problems, linked to the use of fluoroscopy in hospital catheterisation labs and outpatient radiographic diagnostic laboratories. ORSIF will raise awareness of these dangers and focus on advocating for better safety measures to protect the physicians and staff that work in these labs.
Biotronik has announced the European market launch of the Pantera Pro semi-compliant coronary balloon dilatation catheter. The Pantera Pro workhorse balloon received CE mark in January 2015.
Admedus’ CardioCel will be featured in a number of presentations at the American Association for Thoracic Surgery (AATS) Mitral Conclave 2015 meeting (23–24 April, New York, USA) and the 95th AATS Annual Meeting (25–29 April, Seattle, USA).
SynCardia Systems has received Food and Drug Administration (FDA) approval to conduct an investigational device exemption clinical study on the effective use of its 50cc SynCardia temporary Total Artificial Heart.
The FDA has approved the use of CoreValve for aortic valve-in-valve replacement procedures, meaning that the transcatheter aortic valve implantation (TAVI) device is now the first such device to be approved for valve-in-valve procedures in the USA both for patients who are high risk and for those who are at extreme risk. The device is already approved as an alternative to surgery, for first-time procedures, for patients who are high or extreme risk.
Cardiac anaesthesia investigators from Germany presented data at the International Anesthesia Research Society’s (IARS) 2015 Annual Meeting and International Science Symposium (21–24 March, Honolulu, USA).
Three US patients have now received the first implants of the Boston Scientific Watchman left atrial appendage closure device. Watchman offers a stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. The device received US Food and Drug Administration (FDA) approval on 13 March.
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