Claret Medical, Inc., a developer of innovative solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures, announced that it has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration for a multicenter study of the Company s Sentinel Cerebral Protection System (CPS) for embolic protection during Transcatheter Aortic Valve Replacement (TAVR). The IDE application is the result of comprehensive and collaborative pre-IDE discussions.
Bard Peripheral Vascular (Tempe, AZ) announced that it has submitted the final module of the premarket approval (PMA) application to the US Food and Drug Administration (FDA) to support approval for the Lutonix drug-coated percutaneous transluminal angioplasty dilatation catheter balloon (DCB).
For the first time, an antidote developed specifically for dabigatran successfully reversed the effects of the anti-clotting medication in healthy volunteers, according to research presented at the American Heart Associations Scientific Sessions 2013.
AstraZeneca (NYSE:AZN) has announced plans to conduct two new clinical studies as part of PARTHENON, AstraZeneca s largest clinical trial program involving over 80,000 patients. The studies are designed to build scientific understanding of BRILINTA (ticagrelor) tablets in additional high-risk patient populations.
Vascular closure devices (VCDs) significantly reduce complications and bleeding in appropriate patients undergoing percutaneous coronary intervention (PCI), according to an article published in Annals of Internal Medicine.
Childrens congenital heart defects may be associated with their mothers exposure to specific mixtures of environmental toxins during pregnancy, according to research presented at the American Heart Associations Scientific Sessions 2013.
Patients better adhered to their medication regimens in the year following hospitalization for acute coronary syndrome (ACS) when they were part of a program that included personalized attention from a pharmacist compared with usual care, according to a study by P. Michael Ho, M.D., Ph.D., of the Denver VA Medical Center, and colleagues.
Medtronic announced on 14 November 2013 that a German court ordered the discontinuation, in its entirety, of a prior court ruling that prohibited Medtronic from commercially marketing or selling the CoreValve system in Germany since 26 August 2013.
The use of Apica s innovative transapical access technology was successfully demonstrated for the first time at the 27th European Association for Cardio-Thoracic Surgery (EACTS) congress in Vienna. EACTS is one of the largest cardiac congress in the world, with around 6,500 participants.
Johns Hopkins engineers and cardiology experts have teamed up to develop a fingernail-sized biosensor that could alert doctors when serious brain injury occurs during heart surgery. By doing so, the device could help doctors devise new ways to minimize brain damage or begin treatment more quickly.
Neovasc has announced that the topline results from its COSIRA trial (a multicentre, prospective, randomised, sham-controlled study) indicate that the company’s percutaneous device (Reducer) significantly improves the symptoms and functioning of patients with refractory angina.
BIOTRONIK has announced that the PK Papyrus covered coronary stent system has received CE mark for the treatment of acute coronary artery perforation.
Neovasc Inc. (TSXV: NVC) has reported topline results for its COSIRA trial assessing the efficacy and safety of the Neovasc ReducerTM, a novel percutaneous device for the treatment of refractory angina. The data shows that the Reducer achieved its primary endpoint, significantly improving the symptoms and functioning of patients disabled by previously untreatable refractory angina. The COSIRA trial also confirmed that the Reducer is safe and well-tolerated, with no reports of device-related serious adverse events. The safety and efficacy data from the randomized, controlled COSIRA trial is consistent with results seen in previous non-randomized pilot studies of the Reducer.
Sunil Rao (Duke Clinical Research Institute, Durham, USA) reported—according to the results of SAFE-PCI for Women trial—that an initial strategy of transradial access is reasonable in women undergoing cardiac catheterisation because it is associated with less bleeding or vascular complications than the transfemoral approach “with the recognition that a proportion of patients will require conversion to femoral access”.
According to the SMART-CASE study, which was presented during a first report investigation at TCT last week, a conservative strategy of only performing percutaneous coronary intervention (PCI) in lesions with a diameter stenosis of >70% does not increase the risk of all-cause death, myocardial infarction, or any revascularisation at 12 months compared with an aggressive strategy of performing PCI in lesions with a diameter stenosis of >50%.
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