Colibri Heart Valve has received an issue notification from the US Patent and Trademark Office regarding the forthcoming granting of a US Patent titled, “Percutaneous replacement heart valve and a delivery and implantation system.” This will be Colibri’s twelfth patent and will issue on 8 September, 2015.
Direct Flow Medical has appointed Mary Edwards as vice president, regulatory and clinical affairs. In her role, Edwards will oversee all global clinical and regulatory efforts, including administration of the company’s US SALUS pivotal trial studying the Direct Flow Medical Transcatheter Aortic Valve System, as well as the DISCOVER post-market European study.
The Medicines Company will present results of recent clinical studies from its cardiovascular product portfolio at the 2015 European Society of Cardiology (ESC) Congress (29 August–2 September, London, UK).
The Icahn School of Medicine at Mount Sinai, New York, USA, has launched an international clinical trial called TWILIGHT to test the safety and effectiveness of treating coronary stent patients with the anti-clotting medication ticagrelor alone, instead of combining it with aspirin, which is the current standard of care. Researchers will analyse the potential benefits of administering ticagrelor to reduce clotting while at the same time reducing the risk of bleeding associated with the use of both medications.
The Cardiovascular Research Foundation (CRF) has announced the late-breaking trials and first report investigations that will be presented at this years’ Transcatheter Cardiovascular Therapeutics (TCT) 2015 scientific symposium. (11–15 October, San Francisco, USA). The studies include ABSORB III, LEADERS FREE, and Sapien 3
Cyberonics and Sorin have provided an update on various matters relating to their pending merger.
The editor-in-chief of Annals of Internal Medicine, Christine Laine, and her fellow editors have called for doctors to confront colleagues who act in a disrespectful manner towards patients after an anonymous essay in the journal highlighted incidences in which unprofessional behaviour was condoned. Laine et al claim that doctors owe it to themselves, their profession, and their patients to address inappropriate actions.
Patients without obstructive coronary artery disease are just as at risk of angina as those with obstructive coronary artery disease, according to new research published in the European Heart Journal - Quality of Care and Clinical Outcomes.
Abiomed has submitted US Food and Drug Administration (FDA) pre-market approval (PMA) supplemental submissions to expand Impella 2.5 PMA approval to the entire Impella family of devices (Impella 2.5, Impella CP and Impella 5.0/LD).
Corindus Vascular Robotics and Unfors RaySafe have announced a distribution agreement to allow Corindus to offer the RaySafe i2 real-time radiation dose monitoring system in conjunction with its CorPath System. The agreement will enable cath lab physicians and staff to better protect themselves from, and monitor for, excessive radiation exposure.
The global interventional cardiology devices market is expected to be worth US$25.16bn by 2020, according to a new report by Grand View Research.
US Endovascular and BrosMed have entered into an exclusive agreement to distribute Artimes semi-compliant and Apollo non-compliant coronary angioplasty catheters.
The FDA has issued a safety alert telling healthcare professionals, patients, and carers about potential serious adverse effects with left ventricular assist devices (LVADs). It says that these adverse events include an increased rate of pump thrombosis with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD. FDA adds that it is “also aware” of bleeding complications related to both devices.
Rishi Sharma (Division of Cardiovascular Research, Kansas City VA Medical Center, Kansas City, USA) and others report in the European Heart Journal that normalisation of total testosterone levels with testosterone replacement therapy is associated with a significant reduction in the risk of myocardial infarction, stroke and all-cause mortality compared with non-normalisation with testosterone replacement therapy and no therapy in men with low testosterone. These findings contradict previous studies that have suggested with testosterone replacement therapy increases the risk of cardiovascular events
Alaide Chieffo (Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy) and others report in Circulation: Cardiovascular Interventions that computed tomography coronary angiography (CTCA) may be a viable alternative to coronary angiography for assessing coronary anatomy in patients undergoing transcatheter aortic valve implantation (TAVI), noting that coronary angiography need only be performed when absolutely necessary.
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