According to a study published in the International Heart Journal, delivery of stem cell therapy to the heart using BioCardia’s Helix transendocardial delivery system results in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open chest procedure.
A study—AIDA (Amsterdam investigator-initiated Absorb strategy all-comers trial)—presented at EuroPCR (16–19 May, Paris, France) and published in The New England Journal of Medicine has provided further evidence that the bioresorbable vascular scaffold (Absorb, Abbott Vascular) is associated with a higher rate of device thrombosis than is an everolimus-eluting, permanent metallic stent (Xience, also Abbott Vascular). However, it did not find evidence that implantation technique (eg. routine postdilation), or any other factor, was an independent predictor of scaffold thrombosis.
ACIST Medical Systems announced results from the ACIST-FFR study (Assessment of catheter-based interrogation and standard techniques for fractional flow reserve measurement), which demonstrated—a press release reports—the consistent and correlative performance of the Navvus microcatheter compared to standard pressure wire systems. The study was presented for the first time at EuroPCR 2017 (16–19 May, Paris, France).
Data for the Resolute Onyx drug-eluting 2mm stent (Medtronic), which were presented at EuroPCR (16–19 May, Paris, France), indicate that device is not associated with any stent thrombosis at one year. Additionally, according to the data, the RESOLUTE ONYX 2.0mm study met its primary endpoint of target lesion failure at one year for the treatment of coronary artery disease in extra small vessels.
According to late-breaking trial presented at EuroPCR (16–19 May, Paris, France), a novel self-expanding transcatheter aortic valve implantation device (TAVI, Centera, Edward Lifesciences) is associated with excellent 30-day outcomes. A press release reports that the valve is associated with a high survival rate (99%) and a low rate of disabling stroke (2.5%) at 30 days. Furthermore, the valve was associated with a 4.9% rate of permanent pacemaker—the lowest rate ever reported in a multicentre trial for a self-expanding valve.
Data presented at EuroPCR (16–19 May, Paris, France) indicate that a metallic bioresorbable scaffold (Biotronik) is associated with a lower risk of scaffold thrombosis compared with a polymeric scaffold. Michael Haude (Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany) reported at a late-breaking trial session at the congress that there was 0% incidence of definite or probable scaffold thrombosis with Magmaris after two years of clinical follow-up in the BIOSOLVE-II trial.
Gore has announced positive results from the REDUCE study, which is assessing the safety and efficacy of its septal occluder devices for the percutaneous closure of patent foramen ovale (PFO). The data were presented at the European Stroke Organisation Conference (ESOC; 16–18 May, Prague, Czech Republic).
Data from the REPRISE III trial indicate that the Lotus transcatheter aortic valve implantation (TAVI) device (Boston Scientific) is associated with a significantly lower rate of death, disabling stroke, and moderate or greater paravalvular leak at one year than is CoreValve (Medtronic). However, because of a problem with the locking mechanism of the delivery system, the Lotus device was pulled from the European market in February 2017.
Teleflex showcased its complex percutaneous coronary intervention (PCI) product portfolio, recently acquired from the purchase of Vascular Solutions, and the new Arrow AC3 Optimus intra-aortic balloon (IABP) at EuroPCR (16–19 May, Paris, France).
In patients undergoing transradial primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), according to a study published in JACC: Cardiovascular Interventions, there is no significant difference in the rate of a composite of death, myocardial infarction and stroke whether they received anticoagulation with bivalirudin or unfractioned heparin
Data presented from ABSORB China and ABSORB Japan at EuroPCR (16–19 May, Paris, France) show the bioresorbable scaffold Absorb (Abbott Vascular) to have comparable safety and efficacy to an everolimus-eluting permanent metallic stent (Xience, Abbott Vascular) at three years. These findings are in contrast to those of the two-year results of ABSORB III, which showed target lesion failure to be higher with Absorb.
New analyses from the PLATINUM Diversity study underscore the need for greater understanding of the clinical and nonclinical barriers that can adversely affect stent-related outcomes. The findings of these new analyses were presented during a late-breaking clinical trial session at the annual meeting of the Society for Cardiac Angiography and Interventions (SCAI; 10–13 May, New Orleans, USA).
New positive data on the self-expanding Medtronic CoreValve platform from the CoreValve ADVANCE and Evolut R FORWARD clinical studies—two large, rigorous global registries—have been presented during the Late-Breaking clinical trial sessions at the 2017 EuroPCR Annual Meeting (Paris, France; 16–19 May). Consistent with the results achieved in clinical trials, the studies reinforce the safety and efficacy profile of the CoreValve system, and the newer CoreValve Evolut R system for the treatment of transcatheter aortic valve implantation (TAVI) in “real-world” patient populations with severe aortic stenosis.
Abiomed has announced the debut of the third generation Impella CP heart pump at the Annual meeting of the Society for Cardiovascular and Angiography Interventions (SCAI 2017) in New Orleans, USA.
Boston Scientific has announced the schedule of key data presentations, including four late-breaking clinical trials, which will be featured at the annual EuroPCR Scientific Program, in Paris, 16-19 May. The late-breaking clinical trials include the following:
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