Ian Meredith, currently professor of Medicine and Cardiology for Monash University, Director of MonashHeart and Monash Health and as executive director of the Monash Cardiovascular Research Centre in Melbourne, Australia, is to take over from Keith Dawkins as executive vice president and global chief medical officer in January 2017. He will lead clinical and medical affairs across Boston Scientific and will provide global leadership of the company’s clinical trial strategy.
CVRx has appointed Tom Moore to the newly created, officer position of vice president, US Market Development. In this role, Moore will lead all field efforts related to the successful completion of the BeAT-HF (Baroreflex activation therapy for heart failure) pivotal clinical trial. Additionally, he will lead all market development activities critical to preparing the US market for a successful commercial launch after FDA approval.
Interim analysis results from ORION-1, which is evaluating The Medicines Company’s PCSK9si drug, will be presented during a late-breaking trial session at the 2016 American Heart Association scientific sessions (12–16 November, New Orleans, USA). According to a press release, an 90-day analysis of follow-up of all 501 patients enrolled in the study will presented and The Medicines Company anticipates that top-line data from day 180 follow-up for up to 200 patients will also be presented at the session. Furthermore, day 180 follow-up in all 501 patients will be completed, analysed and top-line results disclosed before the end of 2016.
Medtronic has reported that two previously communicated global voluntary recalls related to the HeartWare HVAD System have been categorised as Class 1 by the FDA. Class 1 recalls describe situations where there is reasonable risk of serious adverse health consequences or death. A press release states that in a safety notification letter distributed globally earlier this year, HeartWare notified physicians regarding potential damage to controllers from exposure to moisture through loose power and data connectors.
Somahlution announced the presentation of new data showing the its DuraGraft vascular graft treatment significantly improves long-term outcomes in coronary artery bypass grafting (CABG) surgery. Results were presented today at the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting in Barcelona, Spain.
The MAJESTIC trial set out to evaluate the performance of the Eluvia paclitaxel-eluting vascular stent system (Boston Scientific) in the treatment of femoropopliteal artery lesions. Two-year results show a greater than 90% freedom from target lesion revascularisation rate.
A study published in the American Journal of Cardiology indicates that 94% of patients have evidence of new brain lesions after undergoing transcatheter aortic valve implantation (TAVI). According to a press release from Keystone Heart, this supports the potential need for their cerebral protection device TriGuard.
Although much of the innovation in transcatheter solutions for structural heart disease is now focused on mitral and tricuspid approaches, novel devices for transcatheter aortic valve implantation (TAVI) are also being evaluated. One such device is the “revolutionary” 2P-Valve, which interventional cardiologist Gilberto Melnick (CardioVolution, Brazil) says provides a new solution to paravalvular leak and has the potential to reduce vascular complications.
Xeltis AG, a clinical-stage medical device company developing the first-ever heart valves designed to enable cardiovascular regeneration, announced today the formation of its international clinical advisory board. Its advisors include Martin Leon (Center for Interventional Therapy, Columbia University Medical Center, New York, USA), Stephan Windecker (Swiss Cardiovascular Center, Bern, Switzerland), and Francesco Maisano (Cardiovascular Surgery, University Hospital, Zurich, Switzerland).
A first-in-man study indicates that percutaneous edge-to-edge repair with Abbott Vascular’s MitraClip system is a safe and feasible treatment for tricuspid regurgitation. According to the study, successful reduction of tricuspid regurgitation with MitraClip was associated with favourable short-term outcomes both in patients undergoing isolated tricuspid repair and those undergoing combined mitral and tricuspid valve repair for severe regurgitation.
Positive clinical data for Medtronic’s investigational Avalus pericardial aortic surgical valve were presented yesterday at the 2016 European Cardio-Thoracic Surgery (EACTS) annual meeting (1-5 October, Barcelona, Spain). The results from the PERIGON (Pericardial surgical aortic valve replacement) pivotal trial showed low rates of adverse valve-related events, high survival and improved haemodynamic performance at one year for the device.
Xeltis has announced that three pediatric patients have been successfully implanted with the world’s first heart valve enabling cardiovascular restoration. The three children were enrolled in the Xplore – I clinical study of Xeltis bioabsorbable pulmonary heart valve – a multicentred feasibility trial currently enrolling pediatric patients from 2 to 21 years of age in leading heart centers in Europe.
Edwards Lifesciences has received the CE mark for its Inspiris Resilia aortic valve, which is the first in a new class of resilient heart valves. A press release reports that the valve incorporates the advanced Resilia tissue and leverages features of the Perimount Magna Ease valve. Furthermore, the Inspiris Resilia valve incorporates the proprietary VFit technology—designed for potential future valve-in-valve procedures.
Francesco Maisano (University Hospital Zurich, Zurich, Switzerland) led a team of cardiac surgeons and cardiologists to perform percutaneous direct annuloplasty with the Cardioband system (Valtech) to treat a 75-year-old patient with tricuspid regurgitation. According to a press release, the patient is doing well.
Royal Philips has announced a new partnership with the World Heart Federation (WHF) to help people better manage their heart health. Aligned with the WHF’s ‘power your life’ campaign, Philips aims to encourage people to take personal responsibility for leading heart-healthy lives and raise awareness about cardiovascular disease.
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