OrbusNeich has announced long-term results from its REMEDEE trial. In addition to showing that the Combo Dual Therapy Stent shows no late target lesion revascularisation, the results demonstrate that the stent proactively promotes functional vessel healing.
The US Food and Drug Administration (FDA) has approved the CardioMEMS heart failure system that measures the pulmonary artery pressures and heart rates of patients with New York Heart Association (NYHA) Class III heart failure who have been hospitalised for heart failure in the previous year. The device allows health care professionals to monitor the condition of their patients remotely.
St Jude Medical has announced it has completed its acquisition of privately held CardioMEMS, developer of the CardioMEMS heart failure system. The acquisition was completed on 30 May 2014.
Biosensors International Group has announced that Jose ("Pepe") Calle Gordo has been appointed the company’s new chief executive officer, with effect from 1 November 2014. Jack Wang will continue with the company to help the transition and take on a new role of chief technology officer. Meanwhile, Yoh-Chie Lu, Biosensors’ executive chairman, will serve as interim chief executive officer during this transitional period.
With enrolment now complete, the baseline patient population data from Biosensors’ LEADERS FREE study was presented for the first time at EuroPCR 2014 (20–23 May; Paris, France) by principal investigator Philip Urban.
Medtronic has announced CE mark approval and launch of the NC Euphora noncompliant balloon dilatation catheter. The NC Euphora balloon catheter is now available in Europe and other countries outside of the United States that recognise the CE mark. It is not yet available in the United States.
St Jude Medical has announced preliminary results from the EnligHTN III study, which found the company’s second-generation EnligHTN renal denervation system provided safe and effective therapy for patients with drug-resistant, uncontrolled hypertension six months post-procedure.
Biotronik announced new results from the subgroup analyses of the BIOFLOW-II clinical trial at the EuroPCR 2014 congress in Paris, France. The results were presented by investigator Manel Sabaté, Hospital Clínico y Provincial de Barcelona, Barcelona, Spain.
A Boston Scientific press release reports that new data for its Lotus transcatheter aortic valve implantation (TAVI) device indicate that the valve is associated with sustained safety and effectiveness at six months. The data were presented at EuroPCR (20-23 May; Paris, France).
Boston Scientific Corporation reports positive three-year follow-up data for the EVOLVE clinical trial, comparing the safety and performance of the Synergy everolimus-eluting bioabsorbable polymer platinum chromium coronary stent system to the Promus element stent system.
Biosensors International has announced enrolment of the first patient in LEADERS Free Japan, a trial involving BioFreedom, the company’s novel polymer and carrier-free drug-coated stent.
Edwards Lifesciences has announced that it has received United States Food and Drug Administration (FDA) approval for its Sapien XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis. This next-generation, lower-profile system, which includes the 29mm valve size for patients with a large native annulus, will allow for the treatment of more patients.
Medtronic has announced the US Food and Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve system for patients with severe aortic stenosis who are at high risk for surgery. This approval is based on research that showed clinical outcomes at one year with the CoreValve system were superior to open heart surgery, the current gold standard for aortic valve replacement.
The principal investigators of the REDUCE (Randomised evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with the Combo dual-therapy stent) trial have announced the enrolment of the first patient at Isala Hospital, Zwolle, the Netherlands.
Cardiovascular Systems presented one-year data and a new economic analysis from its ORBIT II coronary study in a late-breaker session at the Society for Cardiovascular Angiography and Interventions (SCAI) 2014 conference (28–31May; Las Vegas, USA). The ORBIT II study of the company’s Diamondback 360 coronary orbital atherectomy system evaluated the safety and effectiveness of Cardiovascular Systems’ technology in treating severely calcified lesions in coronary arteries.
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