June 11, 2014—Medtronic, Inc. announced that it has submitted the final module of its premarket approval (PMA) application for the In.Pact Admiral drug-coated balloon to the US Food and Drug Administration (FDA). The company projects that it will receive FDA approval of the In.Pact Admiral in early fiscal year 2016. The In.Pact Admiral drug-coated balloon received European CE Mark approval in 2009. In the United States, it remains an investigational medical device under review by the FDA.
Combination treatment involving laser debulking followed by drug-eluting balloon angioplasty is associated with superior outcomes when compared to the use of drug-eluting balloon angioplasty alone in critical limb ischaemia patients with superficial femoral artery stent occlusions, a randomised study from Italy finds.
EKOS Corporation has announced the start of patient enrolment for the Accelerated thrombolysis for post-thrombotic syndrome using the EkoSonic endovascular system (ACCESS PTS) study.
June 4, 2014—Medtronic, Inc. announced the market expansion of two recently US Food and Drug Administration (FDA)-approved devices. The Valiant Captivia thoracic stent graft system proximal FreeFlo tapers line extension with dissection indication and the Total Across crossing support catheter for peripheral artery disease (PAD) in the below-the-knee (BTK) vessel bed are now available in the United States. Medtronic advised that the devices will be featured at the Society for Vascular Surgery s 2014 Vascular Annual Meeting on June 5 to 7 in Boston, Massachusetts.
June 4, 2014—Spectranetics, Inc. announced that findings from the EXCITE ISR (Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis) study demonstrated significant procedural advantage of the company’s laser atherectomy system plus percutaneous transluminal angioplasty (PTA). Principal Investigator Eric J. Dippel, MD, of Genesis Heart Institute in Davenport, Iowa, presented the data at the annual New Cardiovascular Horizons conference, which was held May 28–30, in New Orleans, Louisiana.
May 28, 2014—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that new recommendations have been issued that provide new anatomic, clinical, and technical guidance for the endovascular treatment of aortoiliac peripheral artery disease (PAD). The article was published by Andrew J. Klein, MD, et al online in Catheterization and Cardiovascular Interventions.
Full two-year data from the Mimics study, presented for the first time at the 15th Annual New Cardiovascular Horizons (NCVH) Conference (28–30 May, New Orleans, USA), have confirmed that BioMimics 3D provides a significant improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention. BioMimics 3D, a nitinol stent with unique three-dimensional helical geometry, has been developed by Veryan, based on pioneering research by Colin Caro at Imperial College London, UK, into the link between blood flow mechanics and vascular disease.
Covidien’s Stellarex drug-coated angioplasty balloon continues to be shown as safe and effective for treatment of peripheral arterial disease, according to new 24-month data released from the company’s ILLUMENATE first-in-human study. The Stellarex drug-coated balloon uses EnduraCoat technology, a durable, uniform balloon coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. The first-in-human study results were reported at the EuroPCR Scientific Congress (May 20–23; Paris, France).
Totally percutaneous endovascular aneurysm repair (PEVAR) with an adjunctive preclose technique (Perclose ProGlide) is safe and effective, with minimal access-related complications, and it is non-inferior to standard open femoral exposure, according to results of a randomised trial published in the Journal of Vascular Surgery. Compared with femoral exposure approach, the percutaneous access yielded significantly shorter times to haemostasis and procedure completion and favourable trends in blood loss, groin pain, and quality of life.
In a single-centre feasibility trial, six patients underwent office-based percutaneous endovascular aneurysm repair (PEVAR) with a “largely perfect” outcome. Principal investigator Stuart Harlin, Coastal Vascular Interventional Center, Pensacola, USA, told Vascular News that office-based PEVAR is a “natural progression” as the in-hospital procedure is no longer financially sustainable.
Veryan Medical has announced that the two-year results of the Mimics randomised controlled study with the BioMimics 3D stent system will be presented at the 15th Annual New Cardiovascular Horizons (NCVH) conference taking place between May 28th and 30th in New Orleans, USA. Principal investigator Thomas Zeller, Head of the Department of Angiology at the Universitäts-Herzzentrum, Freiburg-Bad Krozingen, Germany, will present the data during the New Technology session on Friday, May 30th.
Stephen Black, St George’s Hospital, London, UK, told delegates at the Charing Cross Symposium (5–8 April 2014, London, UK) that most of the evidence for deep venous reconstruction is based on single-centre experiences, many of them small, and therefore “extremely weak”.
April 29, 2014—TriVascular Technologies, Inc. announced that the US Food and Drug Administration (FDA) has approved a modification to the indications for the company’s Ovation and Ovation Prime abdominal stent graft systems. The modified indication for use statement clarifies the unique anatomical considerations for patient selection and also includes clarification on appropriate vascular access techniques. The Ovation system received FDA approval in October 2012. The Ovation Prime system was approved in December 2012.
April 7, 2014—Alvimedica Medical Technologies (Catalca, Turkey) announced the launch of the Cre8 BTK drug-eluting stent (DES), a polymer-free device for the treatment of below-the-knee (BTK) lesions, as part of the company s introduction of its endovascular device portfolio. The device was launched at the Charing Cross international symposium in London, United Kingdom, for use in the European Union and other markets that recognize CE Mark approval, which the company received in July 2013.
April 5, 2014—Twelve-month results from the IN.PACT SFA trial studying the In.Pact Admiral drug-coated balloon (DCB) (Medtronic, Inc., Minneapolis, MN) were presented at the Charing Cross international symposium in London. Principal investigator Gunnar Tepe, MD, presented the data, which showed that patients with peripheral artery disease in the superficial femoral artery (SFA) who were treated with the In.Pact Admiral device experienced significantly better outcomes at 12 months after treatment compared to those treated with standard percutaneous transluminal angioplasty (PTA).
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