Results from the BIOLUX randomised control trial, which were presented at EuroPCR 2016, indicate that the Pantera Lux drug-coated balloon (Biotronik) is angiographically non-inferior to stenting with the latest-generation drug-eluting stents at six months for the treatment of in-stent restenosis. The study, according to a press release, is only one of a few randomised controlled trials to compare a latest generation coronary drug-eluting stent to drug-coated balloon in this indication.
Recruitment of patients for iVascular’s ANCHOR clinical trial has been completed with 104 patients treated with the sirolimus eluting stent Angiolite. The first interim three-month data have been presented at EuroPCR Congress 2016.
One-year follow-up results from a paediatric feasibility study of Xeltis bioabsorbable cardiovascular pulmonary graft have been presented as late-breaker at the 96th American Association for Thoracic Surgery annual meeting.
St Jude Medical has launched the Trifecta valve with Glide Technology (GT) in the USA. The valve is designed for the treatment of patients diagnosed with unhealthy, damaged or malfunctioning aortic heart valves.
At EuroPCR (17–20 May, Paris, France), a new global study that involves 4,300 patients from 34 countries was announced. The study, according to a press release, is set to shed light into the use of short duration dual antiplatelet therapy (DAPT) in patients following stenting procedures, with a particular focus on those with a high bleeding risk. The investigator-initiated MASTER DAPT (Management of patients post bioresorbable polymer stent implantation with an abbreviated DAPT regimen) study will be supported by an unrestricted grant from Terumo.
St Jude Medical has announced CE mark approval and European launch of the PressureWire X Guidewire fractional flow reserve (FFR) Measurement System. Designed to identify the severity of narrowings in the coronary arteries of patients with coronary artery disease (CAD), FFR measurement allows for a more effective assessment of coronary lesions (blockages), resulting in more accurate diagnosis. The company will showcase the new PressureWire X guidewire technology at the EuroPCR 2016 meeting (17–20 May, Paris, France). The PressureWire X guidewire European launch will include a measured rollout to targeted countries throughout 2016.
Edwards Lifesciences has announced positive clinical trial results on two of its advanced innovations in surgical heart valves for the treatment of people with aortic valve disease. Data from three studies—COMMENCE, TRANSFORM and FOUNDATION—were presented as part of the late-breaking sessions at the American Association for Thoracic Surgery’s (AATS) 96th annual meeting.
Speaking at EuroPCR (17–20 May, Paris, France), Danny Dvir reported that there is a significant increase in valve degeneration between five and seven years after a transcatheter aortic valve implantation (TAVI) device is implanted. Although stressing that this was a “preliminary analysis” using early-generation devices and, therefore, “we must be cautious”, he estimated that, based on these findings, about half of patients who undergo TAVI may show early signs of valve degeneration within eight years of implantation.
Essential Medical has received CE mark approval for Manta; its large bore vascular closure device. The device is a novel vascular closure device designed to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterisation procedures such as transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty.
A large cohort study, published in Catheterization and Cardiovascular Interventions, indicates that transcatheter aortic valve implantation (TAVI) is associated with an overall 2% risk of upper gastrointestinal bleeding. It also shows that patients who are on triple antithrombotic therapy have a 10-fold increased risk of upper gastrointestinal bleeding compared with patients not on triple antithrombotic therapy.
According to a study published in Open Heart, treatment with the Carillon device (Cardiac Dimensions) significantly reduces annular dimensions and improved mitral regurgitation, heart failure symptoms, and functional capacity in patients with functional mitral regurgitation. These data, from the third multicentre study (TITAN II) of the system, confirm the safe and efficacy of the Carillon device.
Mitralign has announced that enrolment in the first phrase of its SCOUT study, which is evaluating percutaneous tricuspid repair with the Trialign system in patients with functional tricuspid regurgitation, has been completed. The company has also revealed that it has recently received approval to expand the study and enrol an additional cohort of patients in the USA.
Overall one-year survival was over 85% for high-risk or inoperable patients who underwent transcatheter aortic valve implantation (TAVI) with Sapien 3 (Edwards Lifesciences), according to a study published in Circulation. An American Heart Association press release reports that this survival rate is “strikingly higher” compared to patient outcomes reported in studies that used older TAVI systems.
Konica Minolta have introduced a new version of the Sonimage HS1 compact ultrasound system, which is designed to enable improved image quality, streamlined workflow and new cardiac functionality for the point-of-care ultrasound market.
Three PinnacleHealth patients have undergone a new procedure for aortic valve reconstruction, using the patients’ own heart tissue (pericardium) to create the new valves.
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