Abbott announced on 21 August 2013 that it has completed its acquisition of IDEV Technologies, a privately held company focused on developing next-generation medical devices for use by interventional radiologists, vascular surgeons and interventional cardiologists.
One-year outcomes from the TriVascular Ovation global pivotal study were published in the Journal of Vascular Surgery on 26 August 2013. The paper concluded that “one-year outcomes with the Ovation stent graft are promising with excellent demonstrated safety and effectiveness in patients with abdominal aortic aneurysms. These results were similarly remarkable in patients with challenging anatomical characteristics who would be ineligible for treatment with other approved stent grafts.”
TriVascular announced on 17 July 2013 the initiation of a US Post-Approval Study (PAS) of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms. The study’s national principal investigator will be Syed Hussain, director of Vascular and Endovascular Surgery at OSF/HeartCare MidWest and assistant clinical professor of Surgery at University of Illinois College of Medicine in Peoria, USA.
On 27 August 2013, Lombard Medical announced that the first US patients have been successfully treated with Aorfix, the company’s flexible stent graft for the endovascular repair of abdominal aortic aneurysms.
Robert M. Bersin, MD, et al published results from the REFORM study in Catheterization and Cardiovascular Interventions (2013;82:266–273). REFORM is a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula balloon-expandable stent (Cook Medical, Bloomington, IN) for treating atherosclerotic renal artery stenosis (RAS) after suboptimal angioplasty.
AtheroMed, Inc. (Menlo Park, CA) announced that it has completed patient enrollment in the EASE clinical study, which is evaluating the company’s Phoenix atherectomy system in the treatment of peripheral arterial disease (PAD).
Boston Scientific has completed enrolment in the SuperNOVA trial, a global, single-arm, prospective, multicentre trial evaluating the long-term (12 month) safety and effectiveness of the Innova self-expanding stent system. This stent system is designed for treating patients with a narrowing or blockage of the arteries above the knee, often associated with peripheral arterial disease.
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Eating more fruit may decrease the risk of suffering from abdominal aortic aneurysm, according to new research in the American Heart Association journal Circulation. In a Swedish study, people who reported eating more than two servings of fruit daily had a lower risk of abdominal aortic aneurysm than those who ate the least amount of fruit.
On 26 August 2013 Volcano said it has signed an agreement to acquire the Pioneer Plus diagnostic ultrasound transducer and percutaneous catheter from Medtronic. The transaction is structured as an asset purchase and is expected to close by the end of August, subject to customary closing conditions.
Intact Vascular, Inc. (Wayne, PA) announced the completion of enrollment in the multicenter TOBA (Tack Optimized Balloon Angioplasty) study, which is being conducted to gather confirmatory data on the use of the company’s Tack-It endovascular system in the superficial femoral and popliteal arteries.
Cook Medical has completed patient enrolment in a study evaluating the retrograde tibiopedal approach. The new access technique could be used in treating peripheral arterial disease, including for patients with critical limb ischaemia.
On 15 August, Medtronic announced the submission of its first pre-market approval (PMA) module to the FDA for the In.pact Admiral drug-eluting balloon. Designed to treat atherosclerotic lesions in the superficial femoral artery, the novel angioplasty device remains investigational in the USA.
At the Society for Vascular Surgery (SVS) Vascular Annual Meeting (30 May–1 June 2013, San Francisco, USA), Tina M Morrison (Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, USA), gave a presentation on the eligibility for endovascular repair of short neck abdominal aortic aneurysms from the CHAP project.
Results of the INSTEAD-XL, published in Circulation: Cardiovascular Interventions, show that thoracic endovascular aortic repair of uncomplicated type B dissections in addition to medical therapy is associated with improved five-year aorta-specific survival and delayed disease progression. The data from the study were published online on 6 August 2013.
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