Delcath Systems has announced that it has submitted a new drug application to the FDA seeking approval for the company’s proprietary chemosaturation system for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The company included its Generation 2 filter in its submission as a technical change to the chemistry, manufacturing, and control (CMC) module.
On 14 August, Sound Interventions released three-month data from the company’s first-in-human clinical study (SOUND-ITV) to treat resistant hypertension through the use of catheter-based ultrasound.
Vascular Solutions has launched the SuperCross FT, a new flexible-tip version of its line of SuperCross microcatheters. SuperCross FT has been designed to address the majority of complex interventional procedures in which a flexible tipped microcatheter is needed.
Miyuki Sone, from the National Cancer Center, Japan made the case for gelfoam remaining an essential embolic material in the future at GEST 2012 US (May, New York, USA).
Olympus Corp. (7733) rallied the most in six months in Tokyo trading after Terumo Corp. (4543) sought to out maneuver Sony Corp. (6758) by investing 50 billion yen ($640 million) and merging with the camera maker.
Olympus Corp. (7733) rallied the most in six months in Tokyo trading after Terumo Corp. (4543) sought to out maneuver Sony Corp. (6758) by investing 50 billion yen ($640 million) and merging with the camera maker.
Emily A Wood, Division of Vascular Surgery, Stony Brook University Medical Center, USA, spoke at the European Venous Forum Annual Meeting (28–30 June, Florence, Italy) on the results of a study that set out to quantify the incidence of inferior vena cava filter perforations of the inferior vena cava and surrounding structures and to assess the outcomes of filter perforations. The retrospective study found that the most common filter involved in perforating the inferior vena cava was the Bard G2. This was followed by the Bard Recovery and Cook Celect filters.
Back in April we provided an update on Californian company Crux Biomedical’s clever Vena Cava Filter (VCF), which ended with the promise of news to come about its then forthcoming FDA approval. Now the company has announced receipt of FDA clearance for its novel device which features bi-directional retrieval
Californian company Xlumena, Inc. has announced that it has received CE Mark approval to market its AXIOS Stent and Delivery System for biliary tract drainage. The device was previously approved for the treatment of pancreatic pseudocysts. This approval follows CE marking of Xlumena’s NAVIX™ Access Device, a multi-function system that enables exchange-free access, tract dilation and delivery of two guidewires during endoscopic pancreatic pseudocyst drainage
St. Joseph Hospital of Orange on July 11 enrolled its first patient as part of a national clinical trial conducted by Medtronic Inc. for a renal denervation procedure designed to eliminate treatment-resistant hypertension. St. Joseph Hospital is the only medical center in the Los Angeles/Orange County metro area conducting the clinical trial and is one of only four hospitals statewide conducting the study.
Vascular Solutions, Inc. announced that it has launched its Gel-Block embolization pledgets in the United States for use in the treatment of hypervascular tumors and arteriovenous malformations (AVMs). The company believes its new Gel-Block product represents a major improvement in the precision of sizing, consistency of delivery, and ease-of-use over current embolization practice.
Radiation oncologist, Lizbeth Kenny from Queensland, Australia, showed the way to interventional oncologists at the ECIO meeting (25–28 April, Florence, Italy).
Surefire Medical has announced that it has received 510(k) FDA clearance to market the Surefire High-Flow Microcatheter, the next generation of the company s novel infusion technology. The Surefire system is designed to deliver therapy with higher infusion efficiency than conventional microcatheters to treat primary and secondary liver cancer.
Adam, London, UK, who has been president of every major radiology and interventional radiology association in Europe, including CIRSE, the European Society of Radiology and the Royal College of Radiologists, proposed that an alliance with radiation oncology would benefit both interventional radiologists and radiation oncologists: “the radiation oncologists would gain a ‘surgical arm’ to their armamentarium and the interventional radiologists would gain access to the infrastructure and resident medical staff that they need to look after their own patients.” he said.
Adam, London, UK, who has been president of every major radiology and interventional radiology association in Europe, including CIRSE, the European Society of Radiology and the Royal College of Radiologists, proposed that an alliance with radiation oncology would benefit both interventional radiologists and radiation oncologists: “the radiation oncologists would gain a ‘surgical arm’ to their armamentarium and the interventional radiologists would gain access to the infrastructure and resident medical staff that they need to look after their own patients.” he said.
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