Medtronic has decided to recall and stop selling the IN.PACT Amphirion drug-eluting balloon after results from the IN.PACT DEEP clinical study indicated a trend towards a higher rate of major amputation in the drug-eluting balloon arm in patients with below-the-knee disease. The study also showed no benefit with the drug-eluting balloon compared to standard balloon angioplasty in terms of re-intervention and late lumen loss.
Gore has announced the nominees and opening of voting for the 2014 Pioneers in Performance Awards for North America. The announcement was made at the 2014 VEITHsymposium in New York.
Based on forthcoming data from the IN.PACT DEEP clinical study, Medtronic, Inc. (Minneapolis, MN) has recalled and stopped selling its In.Pact Amphirion drug-eluting balloon (DEB) for below-the-knee (BTK) revascularization in patients with critical limb ischemia. The company confirmed that other devices in the In.Pact DEB product family are not subject to this recall. Specifically, the In.Pact Admiral and Pacific DEBs (for use in the superficial femoral artery [SFA]) and the In.Pact Falcon DEB (for use in coronary arteries) remain commercially available in markets where they have been approved.
Ya podemos encontrar lo último en técnicas intervencionistas para tratar el pie diabético, gracias a las enseñanzas del Hospital de Manises a los especialistas vasculares. Un programa de abordaje multidisciplinar que trata esta dolencia, reduciendo así las amputaciones en un 50% y cicatrizando las úlceras en un 85%.
Medtronic, Inc. (Minneapolis, MN) announced that data from the global postmarket ENGAGE registry of the Endurant abdominal aortic aneurysm (AAA) stent graft system for endovascular aneurysm repair (EVAR) demonstrated long-term durability and consistent outcomes at 3 years in a real-world setting. ENGAGE investigator Dittmar Böckler, MD, presented the data at the VEITH symposium, held in New York on November 19–22, 2013.
BTG plc (London, UK) announced that the US Food and Drug Administration (FDA) has approved Varithena (polidocanol endovenous microfoam), which is indicated for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system. The company plans to launch Varithena in the United States during the second quarter of 2014. Formerly known as Varisolve, Varithena is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device.
Bolton Medical, Inc. (Sunrise, FL) announced the initiation of its phase II clinical trial in the United States to study the safety and effectiveness of the Treovance abdominal stent graft with Navitel delivery system in patients with infrarenal aortic aneurysms. The phase II study will include 150 patients enrolled at 30 institutions located throughout the United States. Results of this study will support approval of the product in the United States.
Gore & Associates (Flagstaff, AZ) announced the commencement of enrollment in the Gore EXCLUDER iliac branch clinical study.
The Valiant Mona LSA branch thoracic stent graft system from Medtronic has demonstrated proof of concept in a first-in-human study being conducted under the FDA’s “Innovation Pathway” early feasibility pilot program, according to data presented at the 2013 VEITHsymposium.
A blood cell growth factor can boost the effects of exercise in improving mobility for patients with peripheral artery disease, a clinical study has shown.
Final results from the DURABILITY II trial were presented at the VIVA conference in Las Vegas by Krishna Rocha-Singh. The data from the study support the use of a single, long self-expanding stent in femoropopliteal lesions up to 20cm in length. The study also showed a stent fracture rate under 1% at three years.
Frederico Bastos Gonçalves (Utrecht University Medical Center, Utrecht, The Netherlands) reported that, according to the results of a study, conservative management of primary type Ia endoleaks that occur after endovascular aortic aneurysm repair (EVAR) may be feasible in selected patients.
Gore has announced the Gore Excluder iliac branch endoprosthesis, the first complete, fully engineered system (Gore designed iliac branch and internal iliac components) intended for endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms, has received the CE mark.
A new rotational thrombectomy device is safe and effective in the treatment of acute and subacute deep vein thrombosis in a single session of pharmacomechanical thrombolysis providing results of improved functional outcome.
Gore & Associates (Flagstaff, AZ) announced European CE Mark approval for the Gore Excluder iliac branch endoprosthesis, which is intended for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. Composed of Gore’s established technology platform with its expanded polytetrafluoroethylene graft, the Excluder iliac device is used in conjunction with Gore Excluder abdominal aortic aneurysm endoprosthesis components to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries.
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