Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, the company s next-generation durable polymer drug-eluting stent (DES) technology, and is starting its European market launch. The Promus PREMIER Stent System is designed to provide physicians improved DES performance in treating patients with coronary artery disease. It is the only platform to feature a customized Platinum Chromium (PtCr) stent architecture, the market-leading Everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery system.
St. Jude Medical Inc. recalled a new delivery system used to treat people with a dangerous hole in the heart after discovering the device could fracture in a small number of cases, U.S. regulators said.
Product liability law firm TorkLaw continues to pursue litigation against St. Jude Medical on behalf of injured patients and their families.
Biosensors International Group, Ltd. ("Biosensors" or the "Company", Bloomberg: BIG SP; Reuters: BIOS.SI; SGX: B20), a developer, manufacturer and marketer of innovative medical devices, has announced a collaboration with Terumo Corporation to promote the Nobori drug-eluting stent (DES) system at specific specialist cardiology centers in Japan.
As part of St Jude Medical’s ongoing European trial, the first patient has been implanted with the 25mm Portico transcatheter aortic valve implantation (TAVI) device using the transfemoral delivery system. According to a company press release, the Portico Transfemoral European Trial (Portico TF EU Trial) was established to evaluate the 23mm Portico valve, which recently received European approval, and has been expanded to include the 25mm Portico valve.
Svelte Medical Systems has announced treatment of the first patient in its DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) study at Middelheim Hospital in Antwerp, Belgium. According to a company press release, DIRECT II is a prospective, randomised, multicentre clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to Medtronic’s Resolute Integrity drug-eluting stent. The press release added that study builds on the positive six-month results of the DIRECT I first-in-man study which evaluated the Svelte drug-eluting coronary stent IDS in 30 patients in New Zealand. In DIRECT I, the Svelte drug-eluting coronary stent IDS met all study endpoints and demonstrated in-stent neointimal volume obstruction of 2.7% as assessed by intravascular ultrasound (IVUS), which is one-third to one-half the volumetric obstruction observed in market-leading drug-eluting stent first-in-man studies.
A study published ahead of print in Circulation Cardiovascular Interventions indicates that post dilation in patients with greater than mild paravalvular regurgitation following a balloon-expandable transcatheter aortic valve implantation (TAVI) procedure is safe and effective
Biotronik, a medical device manufacturer based in Germany, received mixed reviews from researchers for its Dreams absorbable drug-eluting stent. Early findings at the company showed positive results for the novel absorbable metal stent, but some researchers feel that the device has limited efficacy.
Abbott (NYSE: ABT) today announced that the XIENCE Xpedition Everolimus Eluting Coronary Stent System received U.S. Food and Drug Administration (FDA) approval and is launching immediately in the United States, providing physicians with a next-generation technology with the largest size matrix in the U.S. market. XIENCE Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies.
A large population-based study from Finland has shown that being unmarried increases the risk of fatal and non-fatal heart attack in both men and women whatever their age. Conversely, said the study investigators, especially among middle-aged couples, being married and cohabiting are associated with “considerably better prognosis of acute cardiac events both before hospitalisation and after reaching the hospital alive.”
Direct Flow Medical has announced that it has received the CE mark for its transcatheter aortic heart valve with a metal-free frame and low-profile transfemoral delivery system. According to a press release, the Direct Flow Medical Transcatheter Aortic Valve System is designed to virtually eliminate aortic regurgitation by allowing complete assessment of haemodynamic performance, repositioning and retrieval after the valve is fully deployed in the native valve annulus. It added that the unique, double-ring design of the valve creates a tight and durable seal around the annulus. The system is designed to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves.
ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (STJ), a global medical device company, today announced European CE Mark approval of its AMPLATZER™ Amulet™ Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). According to research, AF leads to an increased risk for stroke. Sealing off the LAA helps prevent the risk of blood clot formation and release, potentially reducing the risk of stroke. The next-generation percutaneous transcatheter device leverages the design and clinical success of the original AMPLATZER™ Cardiac Plug with additional features allowing treatment of a wider range of appendage anatomies. St. Jude Medical will be showcasing the new AMPLATZER Amulet device during the eighteenth annual Boston AF Symposium at booth 319.
SAUSALITO, Calif., Jan. 17, 2013 /PRNewswire/ -- Sanovas Inc., a life science technology company developing and commercializing the next-generation of micro-invasive diagnostics, devices and drug delivery technologies, announced today that it has filed with the U.S. Food and Drug Administration for clearance of the company s Vas Zeppelin Smart Catheter for the treatment of chronic pulmonary diseases and lung cancer. The technology would be among the smallest interventional catheters commercially available, allowing physicians to access and deliver therapy to some of the tiniest and most remote passageways in the anatomy.
Madrid, Enero de 2013.- El pasado jueves 10 de enero iVascular celebró su evento de presentación en Madrid. La Galería de Cristal del Palacio Cibeles acogió a los 400 profesionales del sector médico que acudieron a la cita para conocer el proyecto iVascular, una empresa enfocada al diseño y fabricación de dispositivos e implantes en el área cardiovascular, con alto componente tecnológico e innovador.
After drugmakers, it is the turn of stent manufacturers to explore markets overseas. South East Asia, Middle East, Latin America, Eastern Europe — regions where regulatory clearances are relatively easy to get — are particularly attractive for these players.
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