A new study indicates that patients with glycosylated haemoglobin A (HbA1c) ≥7 at two years after undergoing percutaneous coronary intervention (PCI) have a higher rate of major adverse cardiac and cerebrovascular events (MACCE) than patients with HbA1c <7. This finding, authors Jin Kyung Hwang (Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea) and others report, suggests that high HbA1c after PCI increases the risk of adverse events.
Abbott Vascular has written a letter to European physicians to say that from 31 May, its bioresorbable vascular scaffold (Absorb) will only be available through clinical registries at “selected sites and institutions”. The letter states that the company is working with “European Regulatory Agencies and the medical expert community” to collect more real-world data for the device. It also notes that “the situation will be reviewed” next year.
Gillian Jessurun (Treant Zorggroep, Scheper Hospital Emmen, The Netherlands) has enrolled the first patient in the investigator-initiated MASTER DAPT (Management of patients post bioresorbable polymer stent implantation with an abbreviated DAPT regimen) study, launching the global investigation.
Cordis has received the CE mark for its new Railway sheathless access system, which is now available in select countries across Europe. Railway is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices.
Preliminary results from the Medtronic -sponsored HVAD LATERAL study have demonstrated overall positive results. The data were presented as a late breaking clinical trial during the 2017 International Society for Heart and Lung Transplantation scientific meeting (ISHLT; 5-8 April, San Diego, USA). Patients with end-stage heart failure, who have not responded to standard medical management and are eligible for heart transplantation, received the HVAD system—a mechanical pump that delivers blood to the body—through a less-invasive thoracotomy procedure.
Results of the TARGET All Comer (AC) clinical trial will be released at annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR; 16-19 May, Paris, France). Optical coherence tomography (OCT) sub-study primary endpoint three-month data will be presented at the conference.
Medtronic’s ENDURANCE Supplemental trial of the company’s HVAD ventricular assist device has failed to meet its primary endpoint of all neurological events at 12 months. However, secondary results have shown superior results for patients treated with the system than those in control arm of the study, who had received the HeartMate II (Thoratec).
HLT has announced that the first patient implants in a feasibility clinical study to assess the safety and performance outcomes of its Meridian transcatheter aortic valve and Pathfinder II delivery system in patients with severe aortic stenosis at high risk for surgery.
NVT has received the CE mark for its Allegra transcatheter aortic valve, which it describes as “distinctive” in a company release. The product features a low-profile transfemoral delivery system.
Insomnia is associated with increased risk of heart attack and stroke, according to new research published in the European Journal of Preventive Cardiology.
Boston Scientific Corporation have definitively agreed to acquire Symetis, a privately-held Swiss structural heart company focused on minimally-invasive transcatheter aortic valve implantation devices, for US$435 million in up-front cash.
This year’s SynCardia awards recognise leadership in the Destination Therapy clinical trial, pioneering use of the 50cc Total Artificial Heart, outstanding outcomes, implant milestones and best launch.
Biotronik has released details of the clinical performance of its Magmaris magnesium scaffold in 1,000 cases as part of the Magnesium 1,000 programme. Among other results, physicians involved in the programme—which is not a clinical trial—reported that 98.8% of scaffolds have been successfully deployed.
Cardiovascular Systems and the Cardiovascular Research Foundation (CRF) have announced that the first subject has been enrolled in the ECLIPSE clinical trial. The subject was treated by Richard Shlofmitz, interventional cardiologist and the Director of the Department of Cardiology at St Francis Hospital, Roslyn, USA, Shlofmitz also treated subjects in Cardiovascular Systems’s ORBIT II and COAST clinical studies.
REVA Medical has announced that it has been granted approval to conduct an expanded clinical trial for its Fantom bioresorbable scaffold in Germany. The Fantom scaffold, made from REVA’s advanced proprietary polymer, is designed to allow the restoration of blood flow in patients being treated for coronary artery disease then resorb from the body over time.
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