A review of haemodynamics in stent development, published in Annals of Biomedical Engineering, suggests that the re-introduction of spiral flow after endovascular treatment for peripheral artery disease (PAD) may support endothelial function and increase patency rates.
A review of haemodynamics in stent development, published in Annals of Biomedical Engineering, suggests that the re-introduction of spiral flow after endovascular treatment for peripheral artery disease (PAD) may support endothelial function and increase patency rates.
Medtronic announced on 2 November 2015 the initiation of the REALITY Study (Directional atherectomy + drug-coated balloon to treat long, calcified femoropopliteal artery stenoses) to evaluate patient outcomes following adjunctive use of directional atherectomy and drug-coated balloon treatment of patients with symptomatic peripheral arterial disease in long, calcified lesions in the superficial femoral artery and/or popliteal artery. The study is sponsored and will be managed by VIVA Physicians, and will have multidisciplinary representation in leadership.
The first two patients have been enrolled in Cardiovascular Systems’ OPTIMIZE peripheral orbital atherectomy system study. Taking place in Europe, OPTIMIZE will evaluate the acute and long-term clinical outcomes of orbital atherectomy with adjunctive drug-coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of peripheral artery disease.
Jotec has announced that since the worldwide market launch more than 500 patients have been successfully treated with the E-liac stent graft. According to the company, E-liac is an innovative stent graft system used not only for the endovascular treatment of aorto-iliac aneurysms but also for isolated iliac aneurysms to preserve blood flow into the internal iliac artery.
Endologix and TriVascular announced on 26 October that they have entered into a definitive merger agreement under which Endologix and TriVascular will combine in a stock and cash transaction. The transaction is valued at US$9.10 per TriVascular share, or a total of approximately US$211 million, based on Endologix’s closing stock price of US$13.81 per share on 23 October 2015.
Vascular Flow Technologies has announced the launch of its Spiral Flow PV Bypass Graft registry at the 31st annual Deutschen Gesellschaft für Gefäßmedezin (DGG) in Münster, Germany.
On 14 October 2015, Avinger announced that it has received 510(k) clearance from the FDA to commence US commercialisation of its Pantheris image-guided atherectomy system for the treatment of patients with peripheral arterial disease. Pantheris combines directional atherectomy with real-time, intravascular visualisation and is designed to empower physicians to precisely remove plaque from blocked arteries, while avoiding disruption of normal arterial wall structures.
The first two cases in the EffPac randomised clinical multicentre trial of its luminor 35 drug-eluting balloon system have been successfully performed, according to iVascular.
Avinger announced on 13 October 2015 interim six-month results for its VISION clinical trial. VISION is designed to evaluate the safety and effectiveness of the Pantheris system to perform directional atherectomy while for the first time ever allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
Endologix announced on 13 October 2015 that it has received FDA approval for the AFX2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms. This new device is the latest innovation in the AFX Endovascular AAA family of products. Endologix plans to highlight AFX2 at the 2015 VEITHsymposium taking place 17–21 November in New York, with a commercial launch in the USA expected to begin in the first quarter of 2016.
A retrospective multicentre study has concluded that internal iliac aneurysms that are less than 4cm in diameter have a low risk of rupture, and suggested that the threshold for elective treatment of the condition may be safely increased from 3cm (current practice) to 4cm.
In-stent restenosis patients with severe claudication or critical limb ischaemia should be treated with drug-coated technologies if they present with focal lesions and with a mechanical block such as covered stents if they have diffuse lesions or occlusion, according to Koen Deloose, Dendermonde, Belgium.
Cardinal Health has announced that it has completed the acquisition of Johnson & Johnson’s Cordis business for US $1.944 billion. Planning has been ongoing since the acquisition announcement in early March 2015, and the integration is off to a successful start with management teams in place worldwide. With the Cardinal Health acquisition of Cordis, devices such as the Cordis S.M.A.R.T Vascular Stent Systems are now part of the Cardinal Health portfolio.
Dedicated venous stents can be effectively used to relieve outflow obstruction at one year following thrombotic disease in both the acute and chronic setting, according to the prize-winning research presented at the European Venous Forum (EVF; 2–4 July, Saint Petersburg, Russia). Prakash Saha, King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, London, UK, said, however, that as deep venous reconstruction is challenging, complex cases may require reintervention or adjunctive procedures.
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