Maquet Cardiovascular LLC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and European CE mark approval for its new Air-Band Radial Compression Device. Indicated to assist hemostasis of the radial artery after a transradial procedure, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist. Air-Band will be commercially available in the European Union later this month and in the United States in April.

Improving patient safety while offering clinicians a more complete picture during interventional procedures, Toshiba America Medical Systems Inc. will showcase Spot Fluoroscopy for its Infinix-i vascular X-ray systems at this year’s Society of Interventional Radiology (SIR) 2013 annual meeting.

 

Tyrx announced the first implantation of its new AigisRx R Fully Resorbable Antibacterial Envelope has taken place at the Quebec Heart and Lung Institute in Quebec City, Canada by Dr. François Philippon. Tyrx announced on Jan. 31, 2013 that it had received a license from Health Canada to market its AigisRx R Fully Resorbable technology.

Cook Medical has launched the VIVO clinical research study to evaluate the safety and effectiveness of the Zilver Vena Venous Self-Expanding Stent in the treatment of symptomatic iliofemoral venous outflow obstruction. This disease is characterized by leg pain, throbbing, swelling and skin discoloration in the legs. 

Nanomix Inc. has initiated clinical testing in the United States to evaluate the omega-3 cardiac panel.  The panel quantitatively tests whole blood specimens for levels of cardiac troponin I (cTnI), myoglobin and H-FABP, biomarkers often used as an aid in the diagnosis of myocardial infarction (MI). The initial testing will be conducted with approximately 170 normally healthy subjects and will provide baseline performance information that will form the basis of future registration clinical studies. 

At Medanta Hospital in Gurgaon, India, five EchoBox devices were connected to five GE Vivid ultrasound systems, streaming live echo images over the web to experienced sonographers located in the United States.

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