Boston Scientific Corporation and ASAHI INTECC have formalised plans to develop a new, differentiated fractional flow reserve (FFR) wire. The joint project focuses on creating a device intended to improve handling compared to existing FFR wires.
Cardium Therapeutics has announced the publication of a review article in the Journal of Cardiovascular Pharmacology that concludes a gene therapy product promoting the growth of blood vessels is “highly warranted” to treat about one million US heart-disease patients and six million more worldwide who are either ineligible or poor candidates for traditional angioplasty, stent placement or bypass surgery.
Juventas Therapeutics has announced that it has successfully completed the phase I arm of the RETRO-HF clinical trial, and fully enrolled the phase II arm that is evaluating the safety and preliminary clinical efficacy for retrograde infusion of JVS-100 in patients with heart failure.
Toshiba has announced that it will feature SURESubtraction Coronary at The European Society of Cardiology (ESC) congress (30 August–3 September, Barcelona, Spain). This software was developed in close cooperation with the Iwate Medical University in Japan, leading hospitals in the USA and Europe and the European based research centre, Toshiba Medical Visualisation Systems.
JenaValve Technology has announced that cardiovascular medical device industry veteran Stefan Schreck has been named the company’s new chief technology officer, effective immediately.
The Centers for Medicare & Medicaid Services (CMS) recently issued a National Coverage Determination (NCD) that extends coverage for Medicare beneficiaries in the United States to Transcatheter Mitral Valve Repair with Abbott’s MitraClip system. The MitraClip system is a first-of-its-kind device that provides new hope for people with severe degenerative mitral regurgitation who are not good candidates for surgery. Treatment with MitraClip can significantly improve symptoms and quality of life by reducing the backward flow of blood through the mitral valve in the heart.
Corindus Vascular Robotics has announced that the Journal of Invasive Cardiology published the results of a retrospective study comparing use of radiation and contrast for patients enrolled in its CorPath PRECISE (Percutaneous robotic-enhanced coronary Intervention) study to a matched traditional manual PCI patient in the July 2014 issue (Vol. 26, Issue 7, 2014). Results of the study demonstrate the CorPath system provides significantly lower harmful radiation exposure to the patient when CorPath is used for the complete intervention.
A study published ahead of print in the Journal of American College of Cardiology: Cardiovascular Interventions supports a minimalist transfemoral approach to transcatheter aortic valve implantation (TAVI) for the treatment of high-risk and inoperable patients with aortic stenosis. Data from the study show that the minimalist approach is associated with shorter length of stay and a lower initial hospital cost with similar safety and efficacy to the standard approach in the hybrid operating room.
Thoratec Corporation has announced that its CE mark clinical trial for HeartMate percutaneous heart pump (PHP) has commenced.
HeartWare International has announced the appointment of Katrin Leadley as chief medical officer effective 1 September, 2014. Leadley brings to HeartWare extensive strategic leadership, with more than 20 years of clinical and industry experience at life sciences firms, including Quintiles, Boston Scientific Corporation and JenaValve Technology in Munich, where she spent the last three years as chief medical officer leading the company’s clinical, regulatory, scientific and medical activities.
Cytori Therapeutics has placed enrolment in the ATHENA and ATHENA II trials on clinical hold and therefore anticipates that it will not be possible to complete enrolment of the ATHENA I trial prior to the end of 2014 as previously anticipated. The decision to place the trials on hold was based on a safety review of reported cerebrovascular events. Symptoms occurred in three patients, of which two patients’ symptoms fully resolved within a short period of time and the third patient has had substantial resolution of symptoms. Such events had not been previously reported in Cytori’s other cardiovascular trials and appear to be related in part to the medical co-morbidities in the treated population and the complex nature of the procedures involved in the trial.
Jeremiah R Brown (One Medical Center Dr, Lebanon, USA) and others report in Circulation: Cardiovascular Quality and Outcomes that a regional multicentre quality improvement intervention significantly reduced the rate of contrast-induced acute kidney injury in patients undergoing non-emergent percutaneous coronary intervention (PCI). The authors report that the intervention could prevent acute kidney injury in one in five PCI patients.
St Jude Medical has announced that the Center for Medicare and Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for the CardioMEMS heart failure system. The CardioMEMS heart failure system is the first and only US Food and Drug Administration approved heart failure monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage heart failure. The NTAP programme, which recognises new technologies that provide substantial clinical improvement over already available therapies, is designed to support timely access to innovative technologies for Medicare beneficiaries.
SynCardia Systems has announced that it received approval on 2 July, 2104 from the United States Food and Drug Administration (FDA) for the SynCardia temporary Total Artificial Heart with SynHall valves, giving the company control over the last key component to manufacture the Total Artificial Heart.
ACIST Medical Systems has announced that it has entered into a strategic agreement with Medtronic to co-promote the world’s first Rapid Exchange FFR (RXi) and High Definition IVUS (HDi) technologies in the United States. Under this agreement, ACIST and Medtronic will work collaboratively to introduce these products into cardiac catheterisation laboratories across the USA.
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