June 19, 2014—Vascular Solutions, Inc. announced the United States market launch of its Gel-Bead embolization spheres for the treatment of hypervascular tumors. Gel-Bead, which received 510(k) clearance from the US Food and Drug Administration in April, will be sold to interventional radiologists who currently embolize hypervascular tumors with microspheres, PVA (polyvinyl alcohol) particles, and gelatin foam slurries.
AngioDynamics has announced obtaining 510(k) clearance for the Celerity tip location system from the US Food and Drug Administration (FDA). The Celerity system has been cleared by the FDA as an adjunct to aid in positioning Peripherally Inserted Central Catheters (PICCs) in adults by providing real time catheter tip location utilising the patient’s cardiac electrical activity.
A press release says the acquisition will result in a combined revenue of US$27 billion, including US$3.7 billion from emerging markets. The transaction is expected to be accretive to Medtronic cash earnings in FY2016 and significantly accretive thereafter.
At a time when obesity, type 2 diabetes, and their complications are a veritable epidemic worldwide, researchers at the University of Montreal and CHUM Research Centre (CRCHUM) recently demonstrated the potential of retinoic acid (RA), a derivative of Vitamin A, in treating obesity and type 2 diabetes and preventing their cardiovascular complications. The findings were presented June 6, 2014 at the Annual Conference of the Canadian Nutrition Society in Saint John s, Newfoundland.
The results from a small, animal study challenge previously unsubstantiated published reports claiming that a five to 10mm “ice ball” margin beyond the tumour is necessary for effective cryoablation.
Data from the LEVANT 2 trial comparing the Lutonix drug-eluting balloon with angioplasty alone in the treatment of peripheral arterial disease show that the primary endpoints of both safety and efficacy were met and superior efficacy and non-inferior safety of Lutonix compared to control angioplasty was demonstrated.
EKOS Corporation, a BTG International group company, has announced the start of patient enrollment for the ACCelerated ThrombolySiS for Post-Thrombotic Syndrome using the EKOS® System (ACCESS PTS) Study.
Powered by the heart, the cardiovascular system is responsible for pumping blood around the body and transporting oxygen and nutrients to and from cells - including in the brain.
Although pancreatic cancer is the 10th most common cancer in the US, it is the fourth most common cause of cancer deaths, because 9 in 10 cases are only diagnosed after the cancer has spread and there is no effective treatment. Now, a promising pilot study that tested an endoscope with an oxygen sensor raises hope that the deadly disease may be detected earlier via a simple procedure.
Women with significant pelvic vein incompetence are likely to have haemorrhoids, which could suggest a causal link, according to research from a varicose vein clinic.
June 4, 2014—The 36-month results from the SYMPLICITY HTN-2 trial were published by Murray D. Esler, MD, et al, online ahead of print in European Heart Journal. Catheter-based renal denervation using the Symplicity renal denervation system (Medtronic, Inc.) resulted in sustained lowering of blood pressure at 3 years in a selected population of subjects with severe, treatment-resistant hypertension without serious safety concerns, concluded the investigators.
June 2, 2014—Cook Medical announced that the company is engaged in two clinical studies that will provide additional data on the safety and effectiveness of inferior vena cava (IVC) filters.
May 29, 2014—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that a new meta-analysis found that renal artery stenting significantly reduces the risk of serious health problems, including death and stroke, when compared to medical therapy alone. The study, which was led by Alexandre Benjo, MD, was presented at the SCAI 2014 scientific sessions in Las Vegas, Nevada. Dr. Benjo is from the Ochsner Medical Center in New Orleans, Louisiana.
May 27, 2014—Spectranetics Corporation announced that it has entered into a definitive merger agreement to acquire AngioScore, Inc. for $230 million (50/50, cash and stock) plus further payments contingent on commercial and regulatory milestones. The transaction is subject to customary closing conditions. The company expects to close the acquisition on or near June 30, 2014. AngioScore will be a wholly owned subsidiary of Spectranetics.
May 22, 2014—St. Jude Medical, Inc. announced that preliminary results from the EnligHTN III study results were presented during a late-breaking clinical trial session at the EuroPCR 2014 congress being held May 20–23 in Paris, France. The study found that the company’s second-generation EnligHTN renal denervation system provided safe and effective therapy for patients with drug-resistant, uncontrolled hypertension 6 months postprocedure.
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