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).
April 29, 2014—Because refluxing perforators contribute to venous ulceration, investigators sought to describe patient characteristics and procedural factors that impact both rates of incompetent perforator vein (IPV) thrombosis with ultrasound-guided sclerotherapy (UGS) and the healing of venous ulcers (CEAP 6) without axial reflux. The study’s findings were published by Misaki M. Kiguchi, MD, et al in the Journal of Vascular Surgery (2014;59:1368–1379).
April 7, 2014—Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT) announced that the US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate mesylate) for the treatment of venous thromboembolism (VTE), including both deep venous thrombosis (DVT) and pulmonary embolism (PE), in patients who have been treated with a parenteral anticoagulant for 5 to 10 days and to reduce the risk of recurrent DVT and PE. Pradaxa is also approved to reduce the risk of stroke in patients with nonvalvular atrial fibrillation.
Venous expert Jose I. Almeida, MD, discusses the high mark set by current thermal ablation data, the forces affecting adoption of new therapies, and the economic realities facing today’s venous practices.
A look at the new generation of thermal tumescent and nonthermal nontumescent technologies and their best applications.
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