Spectranetics has submitted its pre-market approval application for the Stellarex drug-coated angioplasty balloon to the US Food and Drug Administration (FDA). Stellarex is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral artery disease.
Med Alliance has announced first patient enrolment in the first-in-man study of the Selution novel sirolimus-coated balloon. Patients were enrolled at the Universitaets-Herzzentrum, Bad Krozingen, Germany, and the Franziskus Krankenhaus, Berlin, Germany.
Six-month interim analysis of the Legflow drug-eluting balloon for the treatment of femoropopliteal occlusions (LEG-DEB) registry indicates that “the use of a new generation paclitaxel drug-coated balloon… represents a safe and effective therapeutic strategy,” according to the study investigators. Writing in the Interventional Journal of Cardiology, they note, “In this registry, as expected for this complex patient subset, the Legflow drug-coated balloon appears to be slightly less successful when compared to the outstanding performance achieved by drug-coated balloons in claudicating patients.”
Deep vein thrombosis is a serious but preventable medical condition in which blood clots occur, usually in veins in the lower leg, thigh, pelvis, and sometimes arms. It is treatable, but it can cause illness, disability, and death. It is often underdiagnosed, so it is important to seek medical care if symptoms appear.
Daiichi Sankyo Europe GmbH (hereafter Daiichi Sankyo) has announced data from a new analysis of the phase 3 Hokusai-VTE study, which showed that a reduced dose of LIXIANA® (edoxaban, once-daily 30 mg) was as effective and well-tolerated in preventing recurrent VTE episodes as the standard 60 mg edoxaban treatment regimen, and safer than warfarin in preventing bleeding events in patients meeting the criteria for dose reduction.
"Pulse" is one of the most well-known medical terms. It is symbolic of medicine and widely familiar as a measure of our heartbeat.
The heart rate is one of our vital signs - it is the number of times a minute that our heart contracts or beats.
Normal blood pressure is vital to life: without the pressure that forces our blood to flow around the circulatory system, no oxygen or nutrients would be delivered through our arteries to the tissues and organs.
Due to an absence of standardised protocols, major amputation is being over utilised worldwide as a treatment for critical limb ischaemia, according to Mary Yost, president and senior analyst at The Sage Group LLC, who gave a presentation at the 2016 New Cardiovascular Horizons annual meeting (1–3 June, New Orleans, USA).
Despite improved outcomes in recent drug-coated balloon trials, standard balloons still have an important and complementary role to play in treating superficial femoral artery (SFA) disease, said S Hinan Ahmed, San Antonio, USA, at the 2016 New Cardiovascular Horizons annual conference (1–3 June, New Orleans, USA).
Physicians have now treated over 1,000 patients with the Vici Venous Stent. The product received CE mark in October 2013 and was first implanted in January 2014. Subsequently, it has been launched in 13 countries worldwide. Veniti says that the stent design allows the physician to confidently treat the millions of patients suffering from chronic venous disease associated with venous outflow obstruction.
Lombard Medical has received CE mark approval for its IntelliFlex Low Profile (LP) delivery system for the Aorfix endovascular stent graft. This new system will be used for the delivery of the Aorfix endovascular stent graft, the only abdominal aortic aneurysm stent graft with global approval to treat aortic neck angulation up to 90 degrees. The company plans to begin shipments in July to its direct markets in the UK and Germany, and expects a full commercial launch in the other European markets later in the year.
BTG has announced that the US Food and Drug Administration (FDA) has approved an extension of the post-activation shelf life of Varithena (polidocanol injectable foam) 1% to 30 days from seven. The announcement was made on 6 July 2016.
Jotec has announced that it has completed enrolment in the PLIANT (Patients with iliac aneurysm undergoing endovascular stenting with a new generation of low profile E-liac stent graft system) study. PLIANT is an observational, prospective, non-randomised, multicentre, single-arm study to evaluate clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of unilateral or bilateral aorto-iliac or isolated iliac aneurysm.
Essential Medical announced on 8 July 2016 that it has received investigational device exemption (IDE) approval from the FDA to begin the US clinical trial for Manta, the company’s large bore vascular closure device.
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