Abiomed has received US Food and Drug Administration (FDA) pre-market approval for the Impella 2.5 heart pump during elective and urgent high risk percutaneous coronary intervention procedures. This approval is based on the extensive clinical data submitted by Abiomed to the FDA to support this pre-market approval as part of the 515 initiative.
Micell Technologies has begun patient enrolment in DESSOLVE III, a randomised, controlled clinical trial comparing the MiStent sirolimus eluting absorbable polymer coronary stent system with the Xience everolimus eluting coronary stent system.
CardioKinetix has announced three-month clinical and echocardiographic results of PARACHUTE China, a study of 31 Chinese patients treated consecutively with the company’s Parachute ventricular partitioning device.
The results of the BEST (Randomised comparison of coronary artery bypass surgery and everolimus-eluting stent implantation in the treatment of patients with multivessel coronary artery disease) study indicate that the long-term rate (4.6 years) of major adverse cardiac events is significantly lower in patients with multivessel disease undergoing coronary bypass grafting (CABG) than those undergoing percutaneous coronary intervention (PCI) with an everolimus-eluting stent. However, a registry study has indicated that there is no difference in mortality rates between PCI with everolimus-eluting stents and CABG
HeartIT has launched CloudCMR, designed to promote worldwide sharing of de-identified cardiovascular magnetic resonance images for education, research, and quality control purposes. The system offers a centralised location where colleagues can collect cases from multiple geographically or politically separated centres. It also allows users to categorise image and report data suitable for interesting cases, training, or even multi-centre clinical trials.
Antiplatelet drug ticagrelor (Brilinta) works faster and is more effective in blocking platelet activity in low-risk patients with acute coronary syndrome than clopidogrel, according to a new study presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions (6–9 May, San Diego, USA).
Harpoon Medical has enrolled the initial three patients in an early feasibility study of its repair system for the minimally invasive, beating-heart treatment of mitral valve regurgitation. The initial first-in-human procedures were performed at the Department of Cardiovascular Surgery and Transplantology, Jagiellonian University John Paul II Hospital, Poland, by the team of Krzysztof Bartus, Jerzy Sadowski, Boguslaw Kapelak, James Gammie, and Andrzej Gackowski.
Cardiovascular Systems (CSI) featured two-year data from its ORBIT II study of the company’s Diamondback 360 coronary orbital atherectomy system, the only US Food and Drug Administration (FDA)-approved atherectomy technology indicated for the treatment of severely calcified lesions, in a late-breaking presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) conference (6–9 May, San Diego, USA).
Pie Medical Imaging has released the 3mensio Structural Heart, dedicated to the planning of structural heart interventions. The new release includes an optimised mitral workflow and a new septal crossing workflow for planning of mitral valve procedures to determine the appropriate access route based on computed tomography images. The new innovations will be exhbitied at the upcoming EuroPCR meeting (19–22 May, Paris, France).
Medtronic has announced the start of a clinical study using Medtronic technologies to determine whether paroxysmal and persistent atrial fibrillation can be treated with a combination of two ablation procedures targeting different anatomical locations—specifically, the pulmonary veins and the renal arteries. Study patients will also receive an implantable cardiac monitor to track their heart rhythm on an automatic and continuous basis.
Boulle Medtech, a Jean Boulle Group medical technology company and the founding investor of Tendyne Holdings, has announced that the Tendyne transcatheter mitral valve implant was successfully implanted in the first patient in the USA. This follows successful implants in Great Britain and Australia in December 2014.
Infraredx has announced the enrollment of 1,000 patients in its Lipid-Rich Plaque (LRP) study. The study is a prospective, multicentre clinical trial designed to identify a correlation between lipid-rich plaques detected by the company’s TVC Imaging System and the occurrence of a cardiac event within two years. The first-in-class dual-modality intravascular imaging system integrates near-infrared spectroscopy (NIRS) with intravascular ultrasound (IVUS) technology, allowing clinicians the ability to assess vessel structure and plaque composition.
STENTYS has announced that it has received CE marking for its new self-apposing stent system ahead of plan, which will allow the company to market the new products in Europe and in all the other countries where this certification is recognised. STENTYS will officially launch Xposition S at the EuroPCR conference on 19 May, 2015.
The Medicines Company has announced that it has received the CE mark for cangrelor (Kangrexal)—the first and only intravenous antiplatelet agent that provides immediate, consistent, and rapidly reversible P2Y12 inhibition. The company also announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9–2, with one abstention, to recommend approval of the drug.
An expert consensus statement released today by the Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC), Heart Failure Society of America (HFSA) and The Society of Thoracic Surgeons (STS) provides new guidance to help physicians match the right device with the right patient. The statement has been endorsed by the American Heart Association (AHA), Cardiological Society of India (CSI) and the Latin American Society of Interventional Cardiology (SOLACI). The Canadian Association of Interventional Cardiology (CAIC) has affirmed the value of the statement.
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