St Jude Medical has announced that its 25mm transcatheter aortic valve implantation (TAVI) Portico device has received the CE mark. The company states that the approval means that Portico system can now be used in more patients.
Svelte Medical Systems has announced that the final patient in the DIRECT II (Direct implantation of rapamycin-eluting stents with bioabsorbable drug carrier technology) study has been completed. DIRECT II is a prospective, randomised study that compared the safety and efficacy of Svelte’s drug-eluting coronary stent integrated delivery system (IDS) with the Resolute Integrity drug-eluting stent (Medtronic) in 159 patients at 19 investigative sites.
Global Genomics Group has announced that it has completed enrolment of the 5,000-patient discovery cohort of its GLOBAL (genetic loci and burden of atherosclerotic lesions) clinical study. Pilot data for the first cohort of patients are expected later this year.
In a study to be presented at the Society for Maternal-Foetal Medicine’s annual meeting, The Pregnancy Meeting, in New Orleans, USA, researchers will report that obesity during pregnancy is an independent risk factor for long-term cardiovascular morbidity, and these complications tend to occur at a younger age. Researchers concluded that obese pregnant patients might benefit from cardiovascular risk screening that could lead to early detection and secondary prevention of cardiovascular morbidity.
More people who have known coronary heart disease die from other causes - such as cancer, and lung and neurological diseases - than heart disease, compared with 20 years ago, according to a Mayo Clinic study published online in Circulation, an American Heart Association journal.
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.
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