A new expert consensus decision pathway will assist clinicians and hospitals in assessing patients’ eligibility for transcatheter aortic valve implantation (TAVI), performing the procedure successfully and providing appropriate follow-up. The “2017 American College of Cardiology (ACC) Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults with Aortic Stenosis” builds on recommendations set forth in the “2014 American Heart Association (AHA)/ACC Guidelines for Management of Patients with Valvular Heart Disease”, and was published the Journal of the American College of Cardiology.
Arterys has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Arterys Cardio deep learning (DL) application. Arterys Cardio DL leverages cloud computing and deep learning in a clinical setting.
St Jude Medical has announced that it will immediately deploy the latest release of cyber security updates for its Merlin remote monitoring system, used with implantable pacemakers and defibrillator devices.
The Medicines Company has announced positive top-line results from the interim analysis with 180-day follow-up for all 501 patients enrolled in the ongoing ORION-1 phase two study of inclisiran, its investigational, first-in-class PCSK9 synthesis inhibitor.
ACIST Medical Systems has announced that enrolment has been completed in its ACIST-FFR study—Assessment of catheter-based interrogation and standard techniques for fractional flow reserve measurement—which is a multicentre trial that began in November 2015 and includes 240 patients at 12 sites across the USA. Final results are expected to be released in mid-2017.
The Women in Cardiology (WIC) section of the American College of Cardiology (ACC) report that 47% of female cardiologists have avoided being pregnant during periods when they would be exposed to radiation, but 57% have been exposed to radiation while pregnant. Furthermore, only 20% used foetal radiation badges and only 24% used additional lead when exposed to radiation during pregnancy.
BioCardia has announced the initiation of its CardiAMP heart failure pivotal trial—a randomised, controlled, multicentre study of up to 260 patients evaluating CardiAMP cell therapy at up to 40 clinical sites in the USA. The trial has been initiated at two centres: Johns Hopkins University (under the leadership of Peter Johnston and Gary Gerstenblith) and the University of Florida at Gainesville, (under the leadership of David Anderson and Carl Pepine).
MicroPort Medical has recently completed the patient enrolment of the pre-market clinical trial of its self-developed VitaFlow transcatheter aortic valve and delivery system (VitaFlow), which is three months prior to the scheduled completion date.
Somahlution has announced enrolment of the first patient in its DuraGraft coronary artery bypass grafting (CABG) European Registry. The registry will evaluate DuraGraft—a vascular graft treatment that, according to a press release, significantly improves long-term clinical outcomes following CABG. The registry will include 3,000 patients from 50 plus European sites across 10 countries. The first enrolled patient was treated at Galway University Hospital, Galway, Ireland.
Abbott Vascular has completed its acquisition of St Jude Medical. This follows receipt of all regulatory clearances necessary for closing. A company press release states that the transaction establishes Abbott as “a leader in the medical device arena and provides expanded opportunities for future growth”.
A new study indicates that “transcatheter valve-in ring”—implanting a transcatheter valve in a surgically placed annuloplasty ring—may be a clinically effective approach for managing tricuspid regurgitation in previously treated patients. However, investigators Jamil Aboulhosn (David Geffen School of Medicine at UCLA, Division of Cardiology, UCLA, Los Angeles, USA) and others found that paravalvular leak was common after the procedure and may lead to further interventions.
NaviGate Cardiac Structures has announced that a novel valved stent that can capture the enlarged annulus in patients with functional tricuspid regurgitation was successfully implanted in a patient with massive incompetence of the tricuspid valve. The company reports that after the implantation, the valve demonstrated excellent valvular function, indicating correction of the massive regurgitation problem.
Following the recent announcement from the American College of Cardiology (ACC) that David J Moliterno is to become the new editor-in-chief of JACC: Cardiovascular Interventions, the society has now named YS Chandrashekhar as the new editor-in-chief of JACC: Cardiovascular Imaging. It says that Chandrashekhar’s term will begin with the July 2017 print issue of the journal and that he replaces Jagat Narula, who has served as editor since the journal first launched in 2008.
According a news report on Mass Device, Boston Scientific has “found a fix” for the problem with its next-generation transcatheter aortic valve implantation (TAVI) device. The company paused implantation of the device in October last year (in Europe, where the device has the CE mark) to investigate a potential problem its locking mechanism.
The American College of Cardiology (ACC) has named David J Moliterno (Jack M Gill Chair, Department of Internal Medicine, University of Kentucky, Lexington, USA) as the new editor-of-chief of the interventional cardiology journal, JACC: Cardiovascular Interventions. An ACC press release states that the journal covers the entire field of interventional cardiovascular medicine and is ranked among the top 10 cardiovascular journals for its scientific impact.
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