Francesco Costa (Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland) and others report in The Lancet that the PRECISE-DAPT score—“a simple five-item risk score”—could be used to predict the risk of out-of-hospital bleeding in patients receiving dual antiplatelet therapy (DAPT) after undergoing percutaneous coronary intervention (PCI). Therefore, the score could be used to determine which patients may be at potential harm from prolonged duration of DAPT.
SynCardia, manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has announced that Brian Brogie has joined the company as vice president of Manufacturing and Facilities. A press release reports that Brogie will oversee manufacturing of SynCardia’s product line, which includes the commercially approved 70cc SynCardia temporary Total Artificial Heart and the new, investigational 50cc Total Artificial Heart for smaller patients.
Following FDA approval, Medtronic’s Melody transcatheter pulmonary heart valve can now be used to treat patients whose surgical bioprosthetic pulmonary heart valves have failed. A press release reports that the valve is specifically designed for use in the pulmonary position and is the first transcatheter pulmonary valve to receive this approval in the USA.
According to a study published in European Heart Journal–Cardiovascular Pharmacotherapy, painkillers that are traditionally considered harmless by the general public are associated with increased risk of cardiac arrest. The authors Gunnar H Gislason (Copenhagen University Hospital Gentofte, Denmark) and others are now advising to avoid the use of diclofenac and to limit ibuprofen to 1200mg per day.
A new study published in Circulation Research finds that the use of haemodynamic support with Impella 2.5 heart pump during high-risk percutaneous coronary intervention (PCI) can reduce the risk of acute kidney injury even when those patients had pre-existing kidney disease and low ejection fraction. According to a press release, the new study builds upon earlier data from PROTECT II—a randomised clinical trial, which found kidney injury rates were numerically lower when more contrast was used during high-risk PCI and adds to the growing body of evidence of the benefits of haemodynamic support with Impella in this context.
The American College of Cardiology (ACC), along with several partnering organisations, has released updated appropriate use criteria for performing coronary revascularisation in patients with stable ischemic heart disease. This update is the second of a two-part revision for coronary revascularisation. The first part updated appropriate use criteria for coronary revascularisation in patients with acute coronary syndromes and was published last December.
MR Solutions’ new 9.4 tesla cryogen-free preclinical scanners was demonstrated to cardiologists at the 20th Annual Scientific Sessions of the Society for Cardiovascular Magnetic Resonance (SCMR; 1-4 February, Washington, DC, USA).
Rules governing the conduct of clinical trials are failing to produce the intended benefits for patients and should be rewritten through a transparent process that involves academic clinical trialists and patient advocates as well as regulators and industry representatives, according to recommendations published in European Heart Journal.
The Patents Court in the UK has determined that one of Boston Scientific’s patents related to outer seals for transcatheter heart valves that was asserted against the SAPIEN 3 valve is invalid, while a second patent is valid and infringed.
Alvimedica’s Illumina study has completed enrolment. The Illumina study has been designed to evaluate the efficacy and safety of the new self-expanding polymer free drug eluting stent—NitiDES—for superficial femoral artery, manufactured by CID, a member of Alvimedica group. Currently this device represents the first attempt to embed a controlled and targeted drug elution (2-3 months) with a polymer-free nitinol platform, according to a company release.
The US Food and Drug Administration (FDA) has approved Tryton Medical’s Premarket Approval (PMA) application for the Tryton side-branch stent for the treatment of coronary bifurcation lesions involving large-side branches (appropriate for a ≥2.5mm stent). The Tryton side-branch stent is the first dedicated bifurcation device to receive regulatory approval in the USA.
According to a review published in JACC: Cardiovascular Imaging, the simple computed tomography (CT) imaging technique of coronary artery calcium (CAC) scanning may be particularly useful when screening for coronary artery disease.
The first patient has been enrolled into Daiichi Sankyo’s ENTRUST-AF PCI study. The multinational, randomised phase 3b study will evaluate a treatment regimen based on the company’s oral, once-daily direct factor Xa-inhibitor edoxaban (Lixiana/Savaysa) against a vitamin K antagonist-based regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement to investigate the incidence of major or clinically relevant non-major ISTH-defined bleeding (MCRB). One thousand-five hundred patients are to be enrolled in ENTRUST-AF PCI from 200 clinical sites across Europe, Korea, Taiwan and the Ukraine.
Teleflex incorporated has announced 510(k) clearance by the US Food and Drug Administration (FDA), and the US commercial launch of the TrapLiner catheter.
The second clinical case using Micro Interventional Devices’ proprietary MIA (minimally invasive annuloplasty) technology for percutaneous mitral and tricuspid repair has been performed on the second patient enrolled in the company’s STTAR clinical study.
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