Abbott is set to acquire St Jude Medical, expanding its portfolio to cover cardiovascular markets such as atrial fibrillation, structural heart and heart failure as well as neuromodulation. The combined company will thus produce devices across cardiovascular, diabetes, vision and neuromodulation markets.
Biotronik has announced that enrolment in its BIOFLOW-V clinical study has been completed. The company reports that 1,334 patients have been enrolled at 91 sites in the US, Canada, Europe, Israel, and the Asia Pacific region in under a year. The aim of the study is to provide further support of the safety and efficacy of the Orsiro hybrid drug-eluting stent system.
Toshiba America Medical Systems´sAquilionTM Lightning has been cleared by the US Food and Drug Administration (FDA) with a more powerful 50-kW generator.
Stents, heart valves, ventricular assist devices, and extracorporeal support systems, as well as vascular grafts and access catheters devices, are prone to failure due to the body’s responses at the blood-material interface; clots can form and inflammatory reactions can prevent the device from performing as indicated. Currently, when this occurs, the only solution is to replace the device.
The use of bleeding avoidance strategies has only a modest effect on the variation in bleeding rates post-angioplasty among hospitals performing this procedure, leaving about 70% of the causes for this variation unexplained, according to a study published in JACC: Cardiovascular Interventions.
Admedus has expanded its distribution partnership with Coroneo to sell its Extra-Aortic Annuloplasty Ring and related products in Australia and New Zealand. According to a press release, Admedus anticipates gaining marketing approval for this unique aortic implant in the second half of 2016.
La Pitié-Salpêtrière Hospital (Paris, France), the world’s leading artificial heart centre, is celebrating the 30th anniversary of the first Total Artificial Heart implantation. The centre has now performed 249 implants of the SynCardia Total Artificial Heart and has implanted more of the devices than any other medical centre in the world. Furthermore, Christian Cabrol, who implanted the first Total Artificial Heart implantation in April 1986, also performed the first heart transplant in Europe (1968) and the first heart-lung transplant (1982).
Boston Scientific has initiated a global, voluntary recall of all models of its Fetch 2 aspiration catheter. A press release reports that the catheters were recalled on 22 March 2016 because of complaints of shaft breakage. The FDA classified the action as a Class 1 recall—which means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.
Abiomed has received FDA pre-market approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps for the treatment of ongoing cardiogenic shock. In this setting, the Impella heart pumps are designed to stabilise the patient’s haemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart. This latest approval adds to the prior FDA indication of Impella 2.5 for high risk percutaneous coronary intervention (PCI), or Protected PCI.
A press release reports that the new Trifecta valve with glide technology provides enhanced valve delivery designed to improve implantation during both minimally invasive and conventional valve replacement procedures. It adds that the valve offers enhanced valve delivery to ease implantation in challenging anatomies and surgical approaches.
Philips has announced that more than 5,000 patients have been enrolled in three prospective clinical studies to assess the safety of deferring cardiovascular interventions using Philips Volcano’s proprietary instantaneous wave-free ratio (iFR) pressure measurement technology compared with conventional fractional flow reserve (FFR) measurements.
According to one-year data presented at the 2016 American College of Cardiology (ACC) meeting (2–4 April, Chicago, USA), fractional flow reserve computed tomography (FFRCT, HeartFlow) significantly reduces the need for invasive procedures to diagnose patients suspected of having coronary artery disease and also leads to a sustained reduction in the cost of care. The results were unveiled in a presentation on the multicentre, controlled, prospective PLATFORM trial, which compared standard diagnostic strategies to a HeartFlow-guided strategy in 584 patients with stable chest pain.
One-month, follow-up patient cohort data from the Revelution trial of Medtronic’s novel drug-filled stent indicate that device is associated with rapid vessel healing without inflammation, as assessed by optical coherence tomography (OCT). These data were presented at the 2016 American College of Cardiology meeting (ACC; 2–4 April; Chicago, USA) and, according to press release, follow the completion of enrolment of 50-patient trial.
AstraZeneca has announced results of two separate sub-analyses of PEGASUS-TIMI 54, which investigated the long-term use of ticagrelor (Brilinta) tablets in patients with a history of myocardial infarction and at least one additional risk factor for thrombotic cardiovascular events at three years. The first subanalysis included patients with peripheral artery disease and the second with diabetes. The results of both analyses show a reduction in major adverse cardiac events (MACE) with ticagrelor plus aspirin compared to placebo plus aspirin that was consistent with the overall PEGASUS-TIMI 54 population.
A study, simultaneously published in The Lancet at presented at the 2016 American College of Cardiology meeting (2-4 April, Chicago, USA), indicates that delaying stenting—compared with conventional percutaneous coronary intervention (PCI)—in patients with ST-segment elevation myocardial infarction (STEMI) does not reduce the risk of death, heart failure, myocardial infarction, or repeat revascularisation. However, the study investigators claim that ongoing studies may “shed further light” on the concept of deferred stenting.
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