Nitiloop has received FDA clearance for its first product, NovaCross, which is intended to be used in conjunction with a guidewire to access discrete regions of the coronary or peripheral vasculature.
ResMed has announced that SERVE-HF, a multinational, multicentre, randomised controlled phase III trial did not meet its primary endpoint. SERVE-HF was designed to assess whether the treatment of moderate to severe predominant central sleep apnoea with Adaptive Servo-Ventilation (ASV) therapy could reduce mortality and morbidity in patients with symptomatic chronic heart failure in addition to optimised medical care.
Direct Flow Medical has named Daniel Lemaitre as president and chief executive officer, and David Boyle as chief financial officer, effective immediately. The moves come as the company enjoys encouraging commercial uptake of its transcatheter aortic heart valve system in Europe, and continues enrolment in SALUS, its pivotal study in the USA. Current chief executive officer Bernard Lyons will be retiring from the company.
Last year, the GHOST-EU registry indicated that the rate of scaffold thrombosis with the bioresorbable vascular scaffold (Absorb, Abbott Vascular) was “not negilible”. This led to concerns about the risk of this potentially fatal complication with the device. However, as technological refinements continue, bioresorbable scaffolds may yet become a workhorse stent of percutaneous coronary intervention (PCI).
Abbott has received CE mark for the latest advancement of its Absorb stent system—Absorb GT1— which combines the fully dissolving stent with a next-generation delivery catheter to help doctors treat people with heart disease.
REVA Medical released initial clinical data on a subset of patients treated with the Fantom sirolimus-eluting bioresorbable scaffold at the EuroPCR 2015 meeting (19–22 May, Paris, France). Reporting the results was Alexandre Abizaid, director of invasive cardiology at the Institute Dante Pazzanese of Cardiology, in Sao Paulo, Brazil, and co-principal investigator for the Fantom clinical trial programme.
Terumo and Arterial Remodeling Technologies have announced that Renu Virmani, a cardiovascular pathologist at CVPath Institute, USA, presented promising pre-clinical data on Terumo’s next-generation drug eluting bioresorbable scaffold for the treatment of coronary artery disease at EuroPCR 2015 (19–22 May, Paris, France).
According to six-month data presented at EuroPCR (19–22 May, Paris, France), the Mitralign percutaneous annuloplasty system (MPAS) is associated with significantly improved valve function at six months. Mitralign now anticipates receiving CE marking for its device later this year.
The final long-term results of the e-BioMatrix registry, which was presented at EuroPCR 2015 (19–22 May, Paris, France) by David Hildick-Smith (Sussex Cardiac Centre, Brighton, UK), have confirmed that the family of BioMatrix drug-eluting stents are safe and efficacious. The results are from 5,470 real-world patients who were followed for more than three years.
Privately held On-X Life Technologies (On-X LTI) has announced that it will launch its Chord-X mitral valve chordal repair system.
Elixir Medical has announced three-year imaging results from the DESolve Nx international pivotal clinical trial for the CE mark-approved, fully bioresorbable DESolve novolimus eluting coronary scaffold system.
Biotronik hosted a scientific symposium regarding Orsiro, the industry’s first hybrid drug-eluting stent (DES) at EuroPCR 2015 (19–22 May, Paris, France). In the symposium, experts emphasised a series of studies which have demonstrated Orsiro’s efficacious performance in the treatment of discrete de novo stenotic lesions and in-stent restenotic lesions as best-in-class for high-risk patient subgroups.
Edwards Lifesciences has voluntarily implemented a temporary pause on enrolment in its Fortis clinical programme, in consultation with trial investigators. A company press release states that it observed evidence of valve thrombosis that it believes warrants additional investigation.
Direct Flow Medical has announced 30-day outcomes from the DISCOVER post-market registry that demonstrate positive real world results for the Direct Flow Medical Transcatheter Aortic Valve System consistent with the ground-breaking results seen in the DISCOVER CE mark trial. The data were presented at EuroPCR 2015 (19–22 May, Paris, France) by Christoph C K Naber, from the Contilia Heart Centre in Essen, Germany.
The findings of the first Xposition (Stentys) clinical experience, as part of the SETUP trial, have been presented at the EuroPCR 2015 conference (19–22 May, Paris, France). The results of this study were also published in the online edition of EuroIntervention.
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