Medtronic has launched the DxTerity diagnostic angiography catheter line, and several transradial-specific products including the DxTerity TRA, InTRAkit access kit and TRAcelet compression device, all of which have received FDA (Food and Drug Administration) clearance and the CE mark for use in diagnostic cardiac catheterisation procedures and percutaneous coronary intervention (PCI).
The first commercial procedures using Corindus Vascular Robotics’ CorPath GRX system have been performed following the company’s recent 510(k) clearance from the US Food and Drug Administration (FDA).
Armetheon has reached agreement with the US Food and Drug Administration (FDA) for a single 1000-patient final pivotal trial for its drug candidate, tecarfarin (Tecarfarin for Anticoagulation Trial, TACT) prior to filing an New Drug Application, which is currently projected to occur in 2019.
The phase three COMPASS trial, evaluating the efficacy and safety of rivaroxaban (Xarelto, Bayer) for the prevention of major adverse cardiac events, including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or with peripheral artery disease, is stopping earlier than planned.
An anticancer agent in development has been shown to promote regeneration of damaged heart muscle—an unexpected research finding that may help prevent congestive heart failure in the future.
The US Food and Drug Administration (FDA) has granted Angionetics “Fast Track” designation for the phase three clinical investigation of Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy, and not amenable to conventional revascularisation procedures.
Cardiovascular systems (CSI) presented six-month data from its LIBERTY 360 degrees post-market study in a presentation at the 29th International Symposium on Endovascular Therapy (ISET; 4-8 February, Hollywood, USA). The study is evaluating the acute and long-term clinical and economic outcomes of peripheral vascular interventions in treating patients with symptomatic lower extremity peripheral artery disease.
In response to a growing body of evidence of the existence of “covert” brain injury to patients undergoing transcatheter aortic valve implantation (TAVI) and other cardiac procedures, The Neurologic Academic Research Consortium (NeuroARC) has announced the simultaneous publication of a consensus paper offering a new classification of neurologic outcomes and testing to better ensure the safety of cardiac procedures. The paper is available online, and will be published in the Journal of American College of Cardiology and a future issue of the European Heart Journal.
Veryan Medical has received a further £13.5m of funding in the form of both equity and debt from its existing investors, including Touchstone Innovations, Invesco Perpetual and Seroba Life Sciences. The debt element of the round has been provided by Silicon Valley Bank in the form of a €5m capital term loan.
The FOURIER trial evaluating whether evolocumab (Repatha, Amgen) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) has met its primary composite endpoint (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalisation for unstable angina or coronary revascularisation) and the key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). No new safety issues were observed.
According to a SeekingAlpha transcript of an Edwards Lifesciences fourth-quarter 2016 earnings conference call, the company has put a halt on enrolment in its clinical trial of Cardiaq.
Multiple sites in Spain have begun enrolling patients in the DuraGraft coronary artery bypass grafting (CABG) European Registry. The registry will evaluate Somahlution’s flagship product, DuraGraft, a vascular graft treatment intended to improve long-term clinical outcomes following CABG surgery.
Ryan D Madder (Frederik Meijer Heart & Vascular Institute, Spectrum Health, Grand Rapids, USA) and others report in EuroIntervention that “telestenting”—ie. when the operator performs stenting in a separate location from the patient—is feasible using a robotic percutaneous coronary intervention (PCI) system (CorPath 200, Corindus Vascular Robotics). They add that additional studies are required to determine “if future advancements in robotics will facilitate telestenting over long geographic distances”.
In a research letter published in the Journal of the American College of Cardiology, Gennaro Giustino (The Icahn School of Medicine, Mount Sinai Hospital, New York, USA) and others report that the use of an embolic protection device during transcatheter aortic valve implantation (TAVI) is associated with a significant reduction in the risk of stroke or death. However, they add that further data—particularly for the individual embolic protection devices available—are warranted.
Northwestern Memorial Hospital has been ranked best in the USA for survival of patients suffering heart failure, and second for survival of patients with heart attack and stroke.
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