Analysts from Technavio have forecast the global renal denervation market to grow at a compound annular growth rate of close to 12% during the forecast period, according to their latest report.
Corindus Vascular Robotics and Acist Medical Systems have come together to provide Fairview Southdale Hospital (Edina, USA) with three leading-edge technologies that are designed to improve workflow. The technologies are the CorPath system, which is the first FDA-cleared robotic-assisted system for percutaneous coronary intervention (PCI); ACIST RXi, which aims to provide the reassurance of accurate and reliable fractional flow reserve (FFR) measurements and the advantages of rapid exchange technology; and ACIST CVi, the purpose of which is to simplify contrast injection for procedures while enhancing safety, efficiency, control and image quality.
Essential Medical has received investigational device exemption (IDE) approval from the FDA to begin the US clinical trial of its large bore vascular closure device (Manta). The study will evaluate the safety and efficacy of vascular access closure using Manta for femoral arterial access sites in patients undergoing percutaneous procedures using sheaths ranging from 10F to 24F. The device is designed to achieve safe, percutaneous closure in a variety of large bore procedures including transfemoral transcatheter aortic valve implantation (TAVI) and ventricular assist devices.
A 64-year old female with severe aortic stenosis and low surgical risk (STS score 1.2%) has been treated at Rigshospitalet in Copenhagen, Denmark, with transcatheter aortic valve replacement (TAVI), becoming the first patient in the NOTION-2 trial. Lars Søndergaard, interventional cardiologist and principle investigator for the trial, and team successfully implanted a Symetis Acurate Neo bioprosthesis.
The Cardiac & Vascular Institute is the first organisation in the North Central Florida USA area of the USA to offer patients with non-valvular atrial fibrillation an alternative to long-term warfarin medication with the newly approved Watchman left atrial appendage closure (LAAC) implant.
Keystone Heart has enrolled the first patient in a pivotal US regulatory study to evaluate the safety and efficacy of Keystone Heart TriGuard embolic deflection device.
Georg Nickenig (Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany) and others report in the Journal of the American College of Cardiology that the Mitralign percutaneous annuoplasty system (MPAS, Mitralign) is a feasible and safe treatment for high-risk patients with functional mitral regurgitation. The system was CE mark approved for functional mitral regurgitation earlier this year.
PinnacleHealth (East Cowes, USA) has enrolled the first patient nationally in a new clinical trial investigating a larger size of the Medtronic CoreValve Evolut R system—the Evolut R 34mm system.
4Tech has announced that its TriCinch device has been used to successfully treat patients suffering from tricuspid regurgitation.
The Cardiothoracic Surgery Department’s Heart Valve Center at NYU Langone Medical Center became the first centre in the world to implant a new heart valve for transcatheter aortic valve implantation (TAVI) in a patient with severe aortic stenosis—the Medtronic CoreValve Evolut PRO TAVI system. A press release reports that the centre is leading the advancement of new technology to help patients suffering from aortic stenosis who are at high to extremely high surgical mortality risk.
Micro Interventional Devices has received the CE mark for its Permaseal transapical access and closure device. The device allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium. According to a press release, it is the world’s first device using compliant soft-tissue PolyCor anchor technology.
Holger Eggebrecht (Cardioangiological Center Bethanien (CCB) and AGAPLESION Bethanien Hospital, Frankfurt, Germany) and others report in the European Heart Journal that the lack of an on-site cardiac surgery department should not be a contraindication to centres performing transcatheter aortic valve implantation (TAVI). They explain that data indicate that TAVI at hospitals without on-site cardiac surgery departments—providing that a heart team approach is used—is both feasible and safe.
Keystone Heart has announced that a pooled analysis of three prospective and comparable clinical studies of patients undergoing transcatheter valve implantation (TAVI) in USA and Europe, have shown that TriGuard cerebral protection significantly reduces stroke rate, lowers CNS infarction and reduces total lesion volume, without adversely impacting the safety of the TAVI procedure.
Direct Flow Medical presented three-year results from its prospective, multicentre DISCOVER Trial at the 2016 EuroPCR meeting in Paris.
New data from the EWOLUTION registry, presented at EuroPCR 2016, confirms safety of the Boston Scientific left atrial appendage closure system (Watchman). The data are for more than 1,000 patients, from across Europe, who received the device and focus on post-procedural drug regimen, impact of centre experience and peri-device leakage. Dual antiplatelet therapy following the implantation also appears to be safe.
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