CHICAGO, Jan. 14, 2013 -- (Healthcare Sales & Marketing Network) -- Phoenix Cardiac Devices, Inc., a medical device company with a novel method of repairing leaky heart valves without open-heart surgery, has enrolled its first patient in a clinical trial aimed at achieving CE Mark approval in Europe.
St. Jude Medical, Inc. (STJ), a global medical device company, today announced European CE Mark approval of its ViewFlex™ Xtra Intracardiac Echocardiography (ICE) Catheter. Designed for control and maneuverability during complex cardiac ablation procedures, the technology will be on display at the eighteenth annual Boston AF Symposium.
Analysts said Wednesday that regulators may be moving toward a recall of St. Jude Medical Inc. s Durata heart wires, a potentially "ominous" development for the company which has been plagued by recalls of its Riata wires.
Madrid, enero de 2013.- Life Vascular Devices, Polytech, Cardiva, Kern Pharma, y Ames; empresas todas ellas de referencia en sus sectores de actividad, han unido sus recursos y know-how para crear la compañía iVascular, dedicada al diseño y fabricación de dispositivos e implantes en el área cardiovascular, con alto componente tecnológico e innovador.
Abbott ($ABT) this week launched a massive U.S. clinical trial for its Absorb drug-eluting bioresorbable vascular scaffold, with plans to enroll up to 2,250 patients. If the results pass muster, they ll support the company s FDA approval bid.
Volcano Corp. (VOLC)s test that shows which patients need heart stents could lead to a $2 billion market within a decade as more doctors use it to improve care, Chief Executive Officer Scott Huennekens said.
ABBOTT PARK, Ill., Jan. 8, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) announced today the initiation of the ABSORB III clinical trial in patients in the United States. This randomized, controlled trial is designed to enroll approximately 2,250 patients, the majority in the United States, and compare the performance of Abbott s drug eluting Absorb Bioresorbable Vascular Scaffold (BVS) device to the company s XIENCE family of drug eluting stents. The start of this trial in the United States follows the recent international commercial launch of Absorb in Europe and parts of Latin America and Asia, including the recent regulatory approval and launch in India a country with a significant and growing prevalence of heart disease. Data from the ABSORB III trial will support U.S. regulatory filings for Absorb.
Randomized Multicenter PARACHUTE IV Clinical Trial Will Compare Minimally Invasive Device to Optimal Medical Therapy MENLO PARK, Calif.--(BUSINESS WIRE)--CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute™ Ventricular Partitioning Device for the treatment of heart failure.
Tryton Medical has pulled in $24 million in equity financing, looping all its investors to pitch in as it prepares to seek FDA approval for its Side Branch Stent to treat bifurcated lesions.
ABBOTT PARK, Ill., Jan. 3, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the XIENCE Xpedition Everolimus Eluting Coronary Stent System received U.S. Food and Drug Administration (FDA) approval and is launching immediately in the United States, providing physicians with a next-generation technology with the largest size matrix in the U.S. market. XIENCE Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies.
Abbott ($ABT) is pursuing an immediate U.S. rollout of its next-generation Xience Xpedition drug eluting stent, backed by a long-awaited FDA approval announced Jan. 3. Four months ago, the product gained a CE mark in Europe.
Abbott has announced that its Xience Xpedition everolimus eluting coronary stent system has received US FDA approval and that it is immediately launching the system onto the USA market
NeoChord has announced that it has received the CE mark for its technology that allows the implantation of artificial chordae tendinae, a proven technique for the repair of mitral valve prolapse, via a transapical, off-pump procedure
NEW YORK, Jan. 2, 2013 /PRNewswire/ -- AbbVie (NYSE:ABBV) today marks its launch as an independent biopharmaceutical company, with employees from more than 40 countries and patients joining AbbVie leaders as they ring the first opening bell of 2013 at the New York Stock Exchange.
Biotronik announced that the first implant has taken place in the BIOHELIX-I trial in the United States. The BIOHELIX–I trial is set to evaluate the safety and performance of the PRO-Kinetic Energy coronary, bare metal stent. The first implant was successfully performed by H Barrett Cheek, of Carolina Cardiology Cornerstone, High Point Regional Hospital, High Point, North Carolina.
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