Medtronic has announced the initiation of its investigational device exemption (IDE) study for the Abre venous self-expanding stent system. The ABRE IDE Study will evaluate the safety and effectiveness of the Abre stent in patients with iliofemoral venous outflow obstruction.
A meta-analysis, published in The American Journal of Medicine, provides further evidence that percutaneous closure of patent foramen ovale (PFO) in patients with recent cryptogenic stroke significantly reduces the rate of recurrent stroke/transient ischaemic stroke. However, it also appears to be associated with an increased rate of atrial fibrillation/flutter. Cardiovascular News spoke to study investigator Deepak L Bhatt (Brigham and Women’s Hospital, Heart & Vascular Center. Boston, USA) about the findings.
Cordis and Medinol have announced that the first US commercial cases using the Elunir drug-eluting stent have taken place at New York-Presbyterian Hospital/Columbia University Medical Center in New York and the Piedmont Heart Institute in Atlanta (both USA). The US FDA approved the stent for the treatment of patients with narrowing in their coronary arteries and it is now being distributed to cath labs in the USA by Cordis.
Corindus Vascular Robotics has announced that it is working with Mayo Clinic in a preclinical study about use of telestenting. A press release reports that telestenting—or the remote robotic treatment for percutaneous coronary intervention (PCI)—may enable physicians to conduct procedures from virtually any location, opening opportunities for more patients globally to receive the benefits of this lifesaving procedure.
Corindus Vascular Robotics will be co-sponsoring courses at multiple leading hospitals to educate interventional cardiologists on transradial access techniques and robotic-assisted vascular interventions.
Uchenna R Ofoma (Geisinger Health System, Danville, USA) and others report in the Journal of the American College of Cardiology that patients who have a cardiac arrest during nights or weekends continue to experience lower survival compared to patients who arrest during daytime hours. They state that survival to discharge in patients who arrested during “off-hours” was an absolute 3.8% lower compared to patients who arrested during “on-hours”.
The results of PRECLUDE, an analysis of data from the ongoing SWEDEHEART quality registry, show that in people with multivessel disease, the risk of a further myocardial infarction remains from occluded arteries that were not stented at the time of their first event.
According to a press release from Tryton Medical, the first patient has been enrolled in the post approval study to evaluate the Tryton side-branch stent for the treatment of coronary artery disease. R Jobe—partner of Joel Schneider (the principal investigator of the study)—performed the first case at NC Heart and Vascular in Raleigh (USA).
Patients who undergo transfemoral transcatheter aortic valve implantation (TAVI) with a minimalist approach and who are discharged the day after the procedure have similar 30-day outcomes to those who are discharged later. Furthermore, the predictors of next-day discharge include male sex, absence of atrial fibrillation, and lower serum creatinine.
Nearly a quarter of patients with chronic ischaemic cardiovascular disease are dead or hospitalised within six months, reports a European Society of Cardiology (ESC) study published in the European Journal of Preventive Cardiology.
The Christ Hospital, Lindner Research Center in Cincinnati, USA, has enrolled the first patient in Svelte Medical System’s OPTIMIZE clinical study; the study is designed to further assess the safety and effectiveness of the Svelte drug-eluting stent integrated delivery system and rapid exchange platforms.
Endotronix has announced successful first-in-human implantation of the Cordella pulmonary artery pressure sensor and the initiation of the SIRONA first-in-human (FIH) clinical trial. Wilfried Mullens (Ziekenhuis Oost-Limburg and University Hasselt) and Matthias Dupont (Ziekenhuis Oost-Limburg), both co-investigators of the SIRONA trial, performed the first implant at the Hospital Ziekenhuis Oost-Limburg in Genk, Belgium.
Essential Medical has announced the completion of the 60-day follow up for its MANTA US pivotal study. Manta is vascular closure device and is designed to close punctures ranging from 10Fr to 25Fr at femoral arterial access sites after percutaneous cardiac procedures that use a large-bore device, such as transcatheter aortic valve implantation (TAVI) and ventricular assist devices.
Miracor Medical Systems and Miracor Medical have announced the closing of € 25m as part of a Series D financing round. The new capital will be used to further develop and commercialise the PiCSO impulse system. The round was led by Ming Capital (Shenzhen, China) and co-led by a strategic investor.
Andrew Goldsweig (Division of Cardiology, University of Nebraska Medical Center, Omaha, USA) and others report in Catheterization and Cardiovascular Interventions that eight factors are associated with increased dose-area product (DAP) during transcatheter aortic valve implantation (TAVI)—including cutdown transfemoral access (vs. percutaneous access). They observe modification of procedural technique may facilitate reduction in radiation exposure.