Teleflex will showcase a wide array of products for minimally invasive interventional applications at the 6th European Conference of Interventional Oncology (ECIO) in Nice, France, from 22–25 April 2015.
ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--Cardiovascular Systems, Inc. (CSII) (CSI), announced today that it has received FDA clearance for the new 4 French (4 Fr) 1.25 Solid Diamondback 360® Peripheral Orbital Atherectomy System (OAS) for the treatment of peripheral artery disease (PAD).
LOWELL, Mass.--(Healthcare Sales & Marketing Network)--Alcyone Lifesciences, Inc., a leader in neural intervention systems for neurological conditions, announced that the Alcyone MEMS Cannula (AMC™), a neuro-ventricular cannula, has received FDA clearance. The AMC is a dual-lumen, MRI-compatible injection and aspiration cannula for use in the brain. The AMC is not intended for implant, and it is intended for single patient use only.
BALTIMORE, April 23, 2015 -- (Healthcare Sales & Marketing Network) -- Clear Guide Medical announces that its first clinical product, the Clear Guide ONE, has received the CE Mark from its Notified Body. The CE Mark allows the marketing and sale of the medical device in 28 Member States of the European Union, as well as Iceland, Norway, Liechtenstein, Switzerland and Turkey. Jack Kent, Director of Regulatory Affairs and Quality System, elaborated on the CE Mark´s importance: "This certification will open global commercialization opportunities in other regions that leverage the CE Mark as a basis for regulatory review. We are currently seeking marketing authorizations in Australia and New Zealand, and we expect to expand to other countries and regions as soon as possible."
Early Experimental and Clinical Experience with a Focal Implant (Tack Endovascular System) for Lower Extremity Post-Angioplasty Dissection Suggests a Safe and Feasible Alternative Treatment
TEWKSBURY, Mass.--(Healthcare Sales & Marketing Network)--Mitralign today highlighted a presentation by Prof. Dr. med. J. Schofer of the Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease, Albertinen Heart Center, Hamburg at the recent American College of Cardiology (ACC) Scientific Sessions detailing his experience with the Mitralign Transcatheter Annuloplasty System. At ACC, Schofer discussed his successful use of the Mitralign System to perform a direct transcatheter annuloplasty on special access patients with tricuspid regurgitation (TR). The Mitralign system is not approved for sale or distribution however, it is currently being evaluated in clinical trials for an indication in functional mitral regurgitation.
MARLBOROUGH, Mass. and MOUNTAIN VIEW, Calif., April 1, 2015 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (BSX) announces that it has signed a definitive agreement to acquire Xlumena, Inc., a venture-backed medical device company that develops, manufactures and sells minimally invasive devices for Endoscopic Ultrasound (EUS) guided transluminal drainage of targeted areas within the gastrointestinal tract. The deal is expected to close this week.
BOSTON, April 15, 2015 -- (Healthcare Sales & Marketing Network) -- InspireMD, Inc. (NYSE MKT: NSPR) ("InspireMD" or the "Company"), a leader in stent embolic protection systems ("EPS"), today announced the completion of its sales restructuring program which began on January 4, 2015. The restructuring was implemented to conserve capital and to align the organization to a new commercial strategy built on third party distribution partners. Reflecting some impact from the transition, as well as the trend towards drug eluting stent use in STEMI patients discussed during our fourth quarter 2014 earnings call last month, total revenues for the first quarter 2015 were approximately $500,000, down sequentially from $850,000 in the fourth quarter 2014.
Hansen Medical has announced that the company’s Magellan 10F robotic catheter has received the CE mark for use in the peripheral vasculature. Achieving this milestone allows the company to market the Magellan 10F robotic catheter in Europe and other countries that require the CE mark.
Medtronic announced on 14 April 2015 that it plans to develop a stent graft system for less invasive treatment of thoracoabdominal aortic aneurysms under an exclusive patent license agreement with South Dakota-based Sanford Health.
Medtronic has initiated the US launch of the HawkOne directional atherectomy system. The HawkOne system can be used to treat all plaque morphologies in patients with peripheral arterial disease, including patients who have plaque blockages that have become severely calcified.
Many nursing home residents who underwent lower extremity revascularization died, did not walk or had functional decline following the procedure, which is commonly used to treat leg pain caused by peripheral arterial disease, wounds that will not heal or worsening gangrene, according to an article published online by JAMA Internal Medicine.
Hatch Medical has successfully brokered the sale of Novotek Innovation’s novel intellectual property portfolio for endovascular repair of abdominal aortic aneurysms. The undisclosed purchase price consisted of a combined cash and stock payment.
The EverFlex self-expanding peripheral stent system from Medtronic has been proven to provide sustained patency in the treatment of long, complex lesions in the superficial femoral and popliteal arteries, according to the three-year results of the DURABILITY II study, which are reported in Catheterization and Cardiovascular Intervention.
MicroPort Endovascular has announced that 18 patients have now been enrolled in a pre-market clinical study to assess the efficacy and safety of the company’s Minos ultra-low profile abdominal aortic stent graft system to treat infrarenal abdominal aortic aneurysms.
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