Intact Vascular’s TOBA II BTK (Tack optimised balloon angioplasty II below the knee) clinical trial has commenced enrolment, with the first patient treated by Joseph Cardenas at Yuma Regional Hospital and the Heart, Lung and Vascular Center in Yuma, USA.
Micro Medical Solutions (MMS) has received CE mark approval for MicroStent, allowing the company to market this technology in Europe. MicroStent is a vascular stent specifically designed to reduce below-the-knee amputations for critical limb ischaemia (CLI) resulting from peripheral artery disease. It is the third MMS product to receive CE mark approval in the past year.
Endologix has completed patient enrolment in the Lucy (Evaluation of females who are underrepresented candidates for abdominal aortic aneurysm repair) study, a multicentre post-market registry designed to explore the clinical benefits associated with endovascular aneurysm repair (EVAR) using the Ovation abdominal stent graft platform in female patients with abdominal aortic aneurysms (AAA), as compared to males. It is the first prospective study evaluating EVAR in females, a population that has historically been underrepresented in EVAR clinical trials.
Heavy alcohol drinking habits over the years may prematurely age arteries, especially in men, putting them at an increased risk for heart disease, according to new research in Journal of the American Heart Association, the open access journal of the American Heart Association/American Stroke Association.
Benjamin W Starnes, chief of Vascular Surgery at the University of Washington, USA, and one of the world’s foremost authorities on the treatment of abdominal aortic aneurysms, has announced midterm results from his physician-sponsored investigational device exemption (IDE) study, administered in conjunction with Harborview Medical Center, Seattle, USA. The ongoing study evaluates physician-modified endovascular grafts (PMEG) for the treatment of juxtarenal aortic aneurysms and assesses a new technology developed by Aortica that could significantly reduce the need for invasive open surgery in patients with aneurysms originating too close to branch arteries that supply blood to vital organs. Results from the first 60 patients using manual planning were recently published in the February issue of the Journal of Vascular Surgery (JVS).
Cagent Vascular has announced US Food and Drug Administration 510(k) clearance of its lead product, the Serranator Alto percutaneous transluminal angioplasty serration balloon catheter. The Serranator is the first of a family of peripheral artery disease technologies under development which incorporate proprietary Serration technology to an angioplasty balloon.
Registration is now open for the 2017 Vascular Annual Meeting, scheduled for 31 May–3 June in San Diego, USA. Plenaries and exhibits open on 1 June.
Alvimedica’s Illumina study enrolment is now complete. The Illumina study has been designed to evaluate the efficacy and safety of the new NiTiDES self-expanding polymer free drug-eluting stent for the superficial femoral artery, manufactured by CID SpA, a member of Alvimedica group. Currently this device represents the first attempt to embed a controlled and targeted drug elution (two to three months) with a polymer-free nitinol platform.
North Dallas Research Associates, Dallas, Texas, and its private practice, Cardiac Center of Texas, have announced their participation in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial.
The US Centers for Medicare & Medicaid Services (CMS) have released the proposed decision memo for the approval of supervised exercise therapy for the treatment of peripheral artery disease (PAD). This was triggered by the receipt last year of a request from the American Heart Association to initiate a national coverage analysis in order to establish a national coverage determination for said exercise therapy programmes.
Medtronic has launched the IN.PACT BTK study to evaluate the effectiveness of using a drug-coated balloon in patients with below-the-knee (BTK) peripheral artery disease.
Changes in tiny blood vessels of the eye may predict a higher risk of later narrowing in the large blood vessels in the legs, according to a study presented at the American Heart Association’s Epidemiology and Prevention Lifestyle and Cardiometabolic Health 2017 Scientific Sessions.
AV Medical Technologies has announced that its Chameleon PTA balloon catheter has received FDA clearance for an expanded indication to include infusion of diagnostic or therapeutic fluids.
PQ Bypass has announced CE mark approval for a trio of proprietary devices: the Torus stent graft system, PQ Snare, and PQ Crossing Device, which enables physicians to perform a fully percutaneous femoropopliteal bypass in patients with TASC II C and D lesions in the superficial femoral artery due to peripheral artery disease (PAD).
Even after adjusting for differences in age and comorbidities, female patients have higher perioperative mortality and lower long-term survival after thoracic endovascular aneurysm repair (TEVAR), according to a study published by the Journal of Vascular Surgery.
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