An analysis of the OVER trial presented at the Society for Vascular Surgery Vascular Annual Meeting (SVS, 5–7 June, Boston, USA) shows that the development of endoleaks were common in patients treated with endovascular aneurysm repair (EVAR) in the study, with an incidence of 31%. Wei Zhou, who presented the results of the analysis, said that 53% of the endoleaks seen in the trial resolved spontaneously.
Biotronik has announced the publication of clinical results from the PEACE I All-Comers registry in The Journal of Endovascular Therapy. Along with earlier results from the 4EVER trial, PEACE I confirms the safety and efficacy of the Pulsar-18 stent with positive patency results, further establishing the benefits of 4 French (4F) intervention in treating even more advanced cases of femoropopliteal disease.
A new issue of the Journal of Endovascular Therapy features an article comparing drug-coated balloons and drug-eluding stents for their performance in femoropopliteal lesions measuring 10 centimeters or longer. While the researches concluded that there was no significant difference between the two treatments, the author of a commentary article predicts that both of these treatments may become first-line therapy for femoropopliteal artery disease.
June 15, 2014—Medtronic, Inc. and Covidien announced that they have entered into a definitive agreement under which Medtronic has agreed to acquire Covidien. The businesses of Medtronic and Covidien will be combined under a new entity to be called Medtronic plc, which will have its principal executive offices in Ireland and its operational headquarters in Minneapolis, Minnesota. Covidien’s headquarters are currently in Ireland, where both companies have a longstanding presence. Medtronic’s Chairman and Chief Executive Officer Omar Ishrak will lead Medtronic plc.
June 13, 2014—Biotronik announced the publication of clinical results from the PEACE I All-Comers Registry by Michael Lichtenberg, MD, et al in The Journal of Endovascular Therapy (2014;21:373–380). The company stated that along with earlier results from the 4EVER trial, PEACE I confirms the safety and efficacy of the company’s 4-F Pulsar-18 stent for treating advanced cases of femoropopliteal disease. The 12-month PEACE data and the 24-month 4EVER data were presented in September at CIRSE 2013, the annual congress of the Cardiovascular and Interventional Radiological Society in Barcelona, Spain.
June 12, 2014—Bard Peripheral Vascular announced that a Circulatory System Devices Panel of the Medical Devices Advisory Committee of the US Food and Drug Administration (FDA) provided a unanimous favorable recommendation to the FDA for approval of the Lutonix drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter for the treatment of peripheral arterial disease (PAD) in the United States.
June 12, 2014—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the publication of a new appropriate use expert consensus document to provide guidance for femoropopliteal arterial interventions. The SCAI noted that blockage affecting arteries above the knee is the most common form of peripheral artery disease (PAD). The document was published by Andrew J. Klein MD, et al and is available online in Catheterization and Cardiovascular Interventions.
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).
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