Teleflex Incorporated has announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter (PICC) has received FDA 510(k) clearance for central venous pressure (CVP) monitoring indication. The announcement comes in a press release issued through Business Wire.
CVRx, Inc., a private medical device company, has launched today a European post-market hypertension registry to track performance outcomes and physician experience using the company s Barostim neo device for hypertension. The registry is expected to enroll up to 500 patients.
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, today announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter (PICC) has received FDA 510(k) clearance for central venous pressure (CVP) monitoring indication. CVP measurement in patients is one of the most important assessments in determining cardiovascular function. The change in CVP, correlated with the patient s clinical status, is a useful indication of adequacy of venous blood volume and alterations in cardiovascular function. CVP also reflects the pumping ability of the right atrium and ventricle.
AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the publication of a study in the Journal of the American College of Surgeons, titled, "Ablation of Perivascular Hepatic Malignant Tumors with Irreversible Electroporation." The study s authors -- all physicians at Memorial Sloan Kettering Cancer Center -- included Doctors Peter Kingham, Yuman Fong, Ami Karkar, Michael D Angelica, Peter Allen, Ronald DeMatteo, George Getrajdman, Constantinos Sofocleous, Stephen Solomon, and William Jarnagin.
Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced the publication of the results from the CaRES multicenter safety registry for its ultrasound imaging agent DEFINITY(R) Vial for (Perflutren Lipid Microsphere) Injectable Suspension.1 The CaRES (Contrast Echocardiography REgistry for Safety Surveillance) study, found that DEFINITY(R) was well-tolerated in patients of different types undergoing clinically indicated DEFINITY(R)-enhanced echocardiography in a broad range of typical clinical settings. The results were published in the July 2012 issue of the Journal of the American Society of Echocardiography (Weiss et al., 2012).
Vascular Closure Systems, Inc.: 30-Day Follow-Up Results of the First in Human (FIH) Clinical Test Series of the FastSeal(R) Bioabsorbable Vascular Access Closure System - 100% Success Rate, Including Patients with Challenging Anatomy and Vessel Condition. The company is pleased to announce that the 30-Day follow-up results for the Phase I FIH clinicals have been perfect, as confirmed by doppler and ultrasound evaluation. The evaluation confirmed normal vessel healing, with complete absorption of the FastSeal(R) sealing element. During the follow-up, no adverse events were observed - no hematoma, pseudoaneurysm or fistulas were present in any of the patients. All patients were asymptomatic and the comfort of the device was excellent, with no groin pain during the deployment, immediately after, at 7, and 30-days after the procedure.
Robert J Lewandowski, associate professor of Radiology, Northwestern University, Chicago, USA, who was part of the GEST 2012 US scientific programme committee, gave Interventional News a quick account of key developments from the interventional oncology sessions from the meeting in New York. What were the key, new interesting developments in interventional oncology to emerge at GEST 2012 US?
Ultrasonix Medical Corporation has received approval from the US Food and Drug Administration for its SonixGPS technology for Vascular Access procedures.
SIR-Spheres microspheres are well-tolerated and effective internal radiotherapy for unresectable, heavily pre-treated colorectal cancer liver metastases, according to results from a new study of more than 600 patients presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting.
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, announced it has acquired Semprus BioSciences (Cambridge, Massachusetts), a biomedical company and spin out from Massachusetts Institute of Technology (MIT). The acquisition includes the core Semprus Sustain(TM) Technology. The transaction brings to Teleflex an innovative and patented platform technology that serves as the basis for next-generation medical devices. The technology is designed to provide the benefits of reducing complications such as thrombosis and microbial adhesion over long durations.
ReCor Medical has reported six-month follow-up data on eight patients who have been treated via renal denervation for their resistant hypertension with the company s Paradise system. According to a company release, this is the only system for renal denervation that is based on ultrasound, not radiofrequency, energy.
Siemens Healthcare (NYSE: SI) has announced that the SOMATOM Definition Edge single-source computed tomography (CT) system – the first single-source CT to use Siemens recently introduced Stellar Detector – has been approved for sale in the United States. With ever-greater patient volumes in the Emergency Department (ED) setting, where 40 percent(1) of CT examinations are performed, hospital demand is increasing for more efficient and cost-effective imaging solutions. With these escalating ED needs in mind, Siemens designed the SOMATOM Definition Edge CT system, which demonstrates Siemens innovation and competitiveness – goals of the Healthcare Sector s Agenda 2013 two-year global initiative.
St. Jude Medical, Inc. (STJ), a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance and will immediately launch the AMPLATZER™ Vascular Plug 4 (AVP 4) for use in transcatheter embolization procedures (minimally invasive procedures that involve the selective blocking of blood vessels) within the peripheral vasculature. Approximately 50,000 peripheral embolizations are performed each year in the United States.
There are plenty of parallels in the history of medical device development, but there’s no doubting the fact that this particular bandwagon is gathering pace at a rate not seen since the early days of coronary angioplasy, balloons, stents and all that. And it’s easy to see why, because renal denervation, despite being a recently developed therapy, does seem to be generating a fistful of good results, demonstrating immediate and sustained blood pressure reduction in patient hitherto resistant to pretty much any other form of anti-hypertensive therapy.
Nordion has announced that organisers of the World Congress on Interventional Oncology (WCIO) 2012 hosted a live administration of the company s TheraSphere Yttrium-90 (Y-90) glass microsphere liver cancer treatment.
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