According to results of the RESPOND post-market study, the Lotus transcatheter aortic valve implantation (TAVI) device is associated with—a press release reports—excellent safety and efficacy outcomes at 30 days post implantation. These data were presented by Volkmar Falk (German Heart Center, Berlin, Germany) at EuroPCR 2016.
St Jude Medical has announced results from two cardiovascular clinical trials presented at EuroPCR 2016. The studies, which look at how St Jude Medical’s fractional flow reserve (FFR) technology impacts patient outcomes in acute coronary syndrome and a comparison of left atrial appendage occlusion (LAAO) therapy to standard medical treatment, were presented during hotline sessions.
Edwards Lifesciences has announced that 30-day data from its European post-approval study of the Sapien 3 transcatheter aortic heart valve demonstrated positive patient outcomes, including the lowest reported mortality and stroke rates seen in the SOURCE family of registries.
Transcatheter Technologies GmbH, a medical device company that has developed a full range of transcatheter valve implantation systems for catheter-based heart valve therapy, has sold its technology portfolio to Venus Medtech. A press release reports that the Transcatheter Technologies’ technology will be the basis of a next-generation product portfolio developed and marketed by Venus Medtech for the Chinese and international markets.
Cardinal Health has entered into a distribution agreement with Biosensors that enables Cordis, Cardinal Health’s interventional vascular business, to sell Biosensors’ coronary stent portfolio. Cordis will sell Biosensors’ coronary stents in select countries in Europe, the Middle East, Africa, Australia and New Zealand. This marks Cordis’ return to the drug-eluting stent market and the beginning of a partnership between Cardinal Health and Biosensors.
Providence Health Care has become the first centre in Canada to adopt the HeartFlow FFRct Analysis, and also first in the world to use the next generation version of the platform.
Results from the CORA-PCI (Complex robotically assisted percutaneous coronary intervention) indicate that robotic-assisted percutaneous coronary intervention (PCI), using the CorPath system (Corindus Vascular Robotics, Boston, MA), is a safe and feasible approach to managing patients with complex lesions. According to the results, clinical success of robotic-assisted PCI was similar to that of manual PCI.
Amgen has received FDA approval for its Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge)—a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420mg of Repatha in a single dose, making Repatha the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.
Sunshine Hearth has updated its clinical strategy, which it says could benefit an under-served population of patients with Class III heart failure and other related conditions. After months of collecting data and researching an optimal strategic path forward, the company is moving forward with a therapeutic strategy focused on neuromodulation rather than counterpulsation.
QT Vascular has received CE mark clearance for the sale and distribution of its Chocolate Heart drug-coated balloon for dilatation of the stenotic portion of coronary arteries for the purpose of improving myocardial perfusion in Europe. The device is the drug-coated version of the company’s percutaneous transluminal coronary angioplasty (PTCA) Chocolate balloon that has been commercially available in the USA since late 2014.
Cardiovascular Systems Inc (CSI) has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for approval of its Diamondback 360 Coronary Orbital Atherectomy System Micro Crown to treat severely calcified coronary arteries for the facilitation of stent placement. A press release reports that CSI expects commercialisation beginning in calendar 2018 and is currently working to find a distribution partner in Japan.
SynCardia Systems has entered into an asset purchase agreement with an affiliate of Versa Capital Management to acquire substantially all of the company’s assets and operations, bringing with it the ability to provide the capital necessary for SynCardia to realise its full potential as the world’s first and only FDA, Health Canada and CE mark approved provider of the Total Artificial Heart and drivers, including the Freedom portable driver allowing clinically stable patients to be discharged from the hospital and live at home and in their communities.
The Tryton Confirmatory Study, recently published in JACC Cardiovascular Interventions, has confirmed the safety and efficacy of the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches (appropriate for a ≥2.5mm stent). In the study, the outcomes of 133 patients who underwent percutaneous coronary intervention (PCI) with the Tryton Side Branch Stent were compared to a performance goal based on performance of the control arm from the Tryton Randomized Controlled Trial (RCT).
A study published in the American Journal of Critical Care has found a high prevalence of delirium in a small cohort of critically ill patients treated with therapeutic hypothermia after cardiac arrest.
A study, published in the JAMA: Internal Medicine, indicates that doctors who receive industry-sponsored meals have higher rates of brand-name drug prescriptions than alternative options within the same drug class. It also showed that meals that cost more than US$20 are associated with higher relative prescribing rates.
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