On 8 December, Abbott announced the initiation of ABSORB II, the first randomised, controlled, multicentre clinical trial to evaluate the safety, efficacy and performance of the Absorb bioresorbable vascular scaffold (BVS) compared to Abbott’s Xience Prime everolimus eluting coronary stent system.
On 4 October, Abbott announced it has begun US patients’ enrolment in the EXCEL (Evaluation of Xience Prime or Xience V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial
Since time that the FAST trial1 was designed in 2007, up to now, there has not been clear evidence to indicate ablation treatments aside from the control of symptoms.2,3 Nevertheless, catheter ablation has expanded its indications thanks to increasing evidence that it is significantly more effective at maintaining sinus rhythm than drug therapy. The expanded indication of catheter ablation has been reflected in the 2011 ACC/AHA/ESC guidelines.3
Aptus Endosystems, a medical device company developing advanced technology for treating abdominal aortic aneurysms (AAA), announced the appointment of James R Tobin to its board of directors. Tobin headed Boston Scientific for 10 years and was responsible for that company’s significant growth during that period.
The US Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental $ew Drug Application (s$DA) for rivaroxaban (Xarelto, Bayer) in combination with standard antiplatelet therapy to reduce the risk of (thrombotic) cardiovascular events in patients with acute coronary syndrome. The application was filed on 29 December 2011.
Four-year results from the LEADERS trial show that BioMatrix Flex, Biosensors’ Biolimus A9-eluting stent system with a biodegradable polymer coating, significantly reduces the risk of very late stent thrombosis compared to that of a drug-eluting stent system with a durable polymer coating.
Boston Scientific has started patient enrolment in the OMEGA clinical trial, designed to evaluate the safety and effectiveness of its Omega platinum chromium bare-metal coronary stent system in treating patients with a single coronary artery lesion.
Boston Scientific announced first patient use and European market launch of the Promus Element Plus everolimus-eluting platinum chromium coronary stent system. The first patient implant in Europe using the new device was performed by Antonio Colombo, director of the Cardiac Catheterization Laboratory at Columbus Hospital and San Raffaele Hospital in Milan, Italy. The new stent system incorporates the platinum chromium (PtCr) alloy and stent design of the Promus Element stent with an enhanced catheter delivery system engineered for improved deliverability in treating patients with coronary artery disease.
Boston Scientific’s Ion Paclitaxel-Eluting Platinum Chromium Coronary Stent System and Taxus Liberte Paclitaxel-Eluting Coronary Stent System have received FDA approval for use in patients experiencing an acute myocardial infarction on 22 February 2012. They are the only drug-eluting stent systems in the USA with an approved indication to treat patients with acute myocardial infarction.
Boston Scientific has announced the exercise of its option to acquire Cameron Health which is the developer of the world’s first and only commercially available subcutaneous implantable cardioverter defibrillator – the S-ICD system.
The Parachute is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischaemic heart failure following a heart attack. This implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.
Eight-month results of the Valentines Trial II global registry have shown that the Dior drug-eluting balloon is a safe and effective treatment for cases of de novo coronary lesions. The follow-up data were presented at Cardiovascular Research Technologies (CRT2012) in Washington, USA, by Antonio Serra, Barcelona, Spain.
Percutaneous coronary intervention with a drug-eluting balloon for instent restenosis is a promising effective therapeutic option with an unexpected low repeat restenosis and target lesion revascularisation rate, according to research presented at the American Heart Association’s Scientific Sessions 2011.
Edwards Lifesciences has received approval from the FDA for the transfemoral delivery of the Edwards Sapien transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. This is the first US commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
Bristol-Myers Squibb and Pfizer have announced that the US Food and Drug Administration (FDA) has extended the action date by three months for the new drug application for apixaban (Eliquis) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The new prescription drug user fee act goal date is 28 June 2012.
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