Medtronic has announced FDA approval of the Assurant cobalt iliac balloonexpandable stent system. The new device features the first balloon-expandable stent made from a cobalt-chromium alloy to be approved by the FDA for the treatment of narrowed iliac arteries. It complements Medtronic’s self-expanding Complete SE Vascular Stent, which is already approved with an iliac indication.
A US-based comparison of the outcome parameters associated with endovascular repair (EVAR) and open repair in the emergency setting (for ruptured abdominal aortic aneurysm) from 2001–2009 found that older patients with ruptured aneurysms were more likely to receive EVAR than open repair.
Nine-month clinical endpoint data from the ORION trial demonstrate excellent outcomes for the Epic self-expanding nitinol stent system (Boston Scientific) in patients with iliac artery disease. Results were presented by Daniel Clair, principal investigator of the trial and chairman of the Department of Vascular Surgery, The Cleveland Clinic Foundation, at the 24th International Symposium on Endovascular Therapy (ISET) in Miami, USA.
On 9 February, Endologix announced the completion of patient enrolment in the prospective, multicentre, randomised clinical trial of a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair (EVAR).
Thirty six-month follow-up data for 161 patients from RESILIENT, a randomised, multicentre trial which compared primary nitinol stent implantation with balloon angioplasty in moderate-length (up to 15cm) lesions in the superficial femoral and proximal popliteal arteries were published in the February issue of Journal of Endovascular Therapy. The current analysis demonstrated that there is sustained benefit of femoropopliteal stenting over angioplasty out to three years. However, an accompanying commentary asks if these results are enough to warrant a change in practice that could result in a dramatic increase in treatment costs.
A new analysis from a two-year follow up of participants in the CREST (Carotid revascularization endarterectomy versus stenting) trial show that carotid artery stenting and carotid endarterectomy are equally effective at halting carotid restenosis in stroke prevention. Results of the analysis were detailed in a presentation at the American Stroke Association’s International Stroke Conference (%ew Orleans, USA, 1–3 February 2012).
Physicians at University Hospitals (UH) Case Medical Center, USA, enrolled their first patient in LEVANT 2, a global, multicentre, randomised clinical trial evaluating the safety and efficacy of the Moxy drug-coated balloon for the treatment of peripheral artery disease.
A study published in October in the Journal of Endovascular Therapy has found that Zilver PTX (Cook Medical) drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment.
Lammer from the University Hospital Vienna, Austria, said that the preliminary data from the VIASTAR trial show a trend towards a higher instent restenosis/occlusion rate with bare metal stents. However, he noted that edge restenosis of the Viabahn (Gore) endoprostheses can still be seen.
For older patients, endovascular repair of an abdominal aortic aneurysm (AAA) offers long-term survival advantages over open repair, researchers found. Among patients ages 65 and up, traditional surgical repair was associated with significantly higher risks of both all-cause and AAA-related death over a mean of about 2.5 years (P=0.01 and P<0.001, respectively), Rubie Sue Jackson, MD, MPH, of Georgetown University Hospital, and colleagues reported in the April 18 issue of the Journal of the American Medical Association.
In May 2012, Medtronic will initiate the IN.PACT Global SFA Trial, a single arm, real-world study of the IN.PACT Admiral drug-eluting balloon (DEB) for revascularisation of femoral-popliteal arteries in patients with claudication and rest pain. The study will be part of the company’s drug-eluting balloon programme which already includes eight registries and 10 randomised controlled trials.
On Sunday evening, CX 34 delegates heard the results of the world’s first multicentre, randomised, controlled trial that compared EVAR and open repair for ruptured abdominal aortic aneurysms. The Dutch AJAX trial results demonstrated no difference between EVAR and open repair in emergent cases. In the same session, the audience also heard an outline of the SWIFT study on the effect of transport on ruptured aneurysm treatment outcomes. While AJAX results shed some light on treatment for ruptured aneurysms, many questions still remain unanswered
Matt Bown, Leicester, UK, led an international team of investigators which identified a single gene that is linked to the development of abdominal aortic aneurysm. During the discussion session, after the results were presented, the point was made that the interaction between the gene LRP1 and environmental factors was key.
Preliminary results from eight patients within the 12-month follow-up window of the PACIFIER trial showed significantly lower target lesion revacularisation was needed for patients in the drug-eluting balloon group vs the percutaneous transluminal angioplasty group. Similarly six-month follow-up from FREEWAY demonstrated a lower target lesion revascularisation rate after Freeway drug-eluting balloon and stent than after plain old balloon angioplasty and stent.
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