Admedus has announced positive data from an independent study into the performance of its tissue engineered bovine pericardial implant CardioCel, which is used in the repair of congenital heart defects in children.
Valix Medical has received a US patent—10,278,820 (percutaneous valve repair and replacement)—for its heart valve repair and replacement technology. A press release reports that the company is developing transcatheter solutions for patients suffering from valvular heart disease and heart failure.
The National Institute for Health and Care Excellence (NICE) has released evidence-based recommendations on the percutaneous insertion of a cerebral protection device to prevent cerebral embolism during transcatheter aortic valve implantation (TAVI).
New data for the PASCAL system (Edwards Lifesciences), which received the CE mark in February 2019 for the management of mitral regurgitation, suggest it may have a role in the management of tricuspid regurgitation. During the first-ever late-breaking trial session at TVT 2019 (12-15 June, Chicago, USA), Neil P Fam (Division of Cardiology, St. Michael’s Hospital, University of Toronto, Toronto, Canada) outlined a multicentre experience of compassionate use of the PASCAL system for patients with severe tricuspid regurgitation.
Speaking during an innovation session at TVT 2019 (12-15 June, Chicago, USA), Mark Hensey (Centre for Heart Valve Innovation, St Paul’s Hospital, University of British Columbia, Vancouver, Canada) outlined the early experience with a purpose-designed temporary pacing guidewire (Wattson, Teleflex). He said the wire delivered “safe and effective pacing” for both aortic and tricuspid positions.
This morning at TVT 2019 (12-15 June, Chicago, USA), in separate presentations, the principal investigators of PARTNER 3 and Evolut Low Risk trials both said that the findings of the studies indicate that transcatheter aortic valve implantation (TAVI) should be the preferred option for appropriate low-risk patients. These statements follow that of PCR at EuroPCR 2019 in which PCR said that these studies, alongside other TAVI data, have led to a series of paradigm shifts in the management of severe aortic stenosis.
Orchestra BioMed and Terumo have formed a global strategic partnership for the development and commercialisation of Virtue sirolimus-eluting balloon (SEB) in the percutaneous coronary and peripheral interventions field.
Cardiovascular Systems recently announced that the first patient has been enrolled in the REACH PVI study. The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy via transradial access for the treatment of peripheral artery disease (PAD) in lower extremity lesions.
New research from Finland found dramatic decreases in mortality from ruptured abdominal aortic aneurysms following a series of simulated staff training sessions on how to handle those life-threatening emergencies.
The SAVE-US (Surfacer system to facilitate access in venous occlusions—United States) pivotal trial has completed enrollment. The SAVE-US trial is evaluating the safety and efficacy of the Surfacer Inside-Out access catheter system (Bluegrass Vascular Technologies) in 30 patients across seven US centres, and demonstrated positive clinical results by meeting its primary and secondary endpoints.
Endologix recently announced that the EC Certificate of Conformity (CE mark) for the Nellix endovascular aneurysm sealing system (Nellix system) has been reinstated by GMED, the EU Notified Body for the Nellix system. The reinstatement followed an assessment of clinical evidence.
The US Food and Drug Administration (FDA) has approved expanded sizes of the Lutonix 018 drug-coated balloon (DCB) to treat long superficial femoral artery lesions in patients with peripheral arterial disease.
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