For the treatment of long lesions and small vessels – two challenging characteristics of coronary artery disease commonly found in patients with diabetes – the Resolute zotarolimus drug-eluting stent from Medtronic delivered successful clinical results, according to new data presented at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
On 22 October 2012, Svelte Medical Systems announced it received conditional approval from the FDA to begin a pivotal study for the Svelte coronary stent Integrated Delivery System (IDS). Approved by the FDA under an investigational device exemption (IDE), the study will evaluate the safety and effectiveness of the Svelte IDS in approximately 370 patients at up to 30 investigative sites in the USA.
St Jude Medical has announced that an analysis of the benefits to using a fractional flow reserve (FFR)-guided intervention strategy found that the technology can improve patient outcomes while saving significant amounts of money. The analysis, which was funded by an educational research grant from St Jude Medical, found that within each of the country’s respective health care systems, the FFR-guided approach is cost-saving, meaning that use of FFR improves health outcomes for patients with multivessel coronary artery disease at lower costs when compared to using angiography alone.
Cappella has announced the multicentre long term follow-up results for its Sideguard coronary side branch stent. Long term follow-up data on the stent was obtained from 399 patients from the United Kingdom, Germany, and Italy. The MACE rate was: 3.7% (30 day follow-up), 7.1% (six months follow-up) and 10.2% (one year follow-up) comparing favourably with existing standard practice.
On 19 October, the US Food and Drug Administration (FDA) expanded the approved transcatheter aortic valve implantation (TAVI) indication for the Sapien Transcatheter Heart Valve (Edwards Lifesciences) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
By Denise Fischer. Hypertension is associated with psychological comorbidities such as anxiety disorders and depression, either contributing to or initiating the condition. Dysfunction of the autonomic nervous system is considered to be the pathophysiological link between hypertension and psychological factors. Psychological comorbidities, such as anxiety and depression, in addition to an aggravating cardiovascular disease, may contribute to a significant impairment of quality of life and consequently to increased hospitalisation and morbidity.
IRVINE, CA--(Marketwire - October 19, 2012) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that it has received approval from the United States Food and Drug Administration (FDA) to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and transapically (through the ribs). With the addition of high-risk patients to those eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can now be treated with the SAPIEN valve. Previously, SAPIEN was approved in the U.S. only for the treatment of inoperable patients via the transfemoral approach.
BETHLEHEM, Pa., Oct. 22, 2012 /PRNewswire/ -- Micro Interventional Devices, Inc. (MID), an emerging cardiovascular medical device company, announced today that the first patient has been treated using its self-sealing, cardiac access and closure technology, Permaseal. The patient is the first to be enrolled in the company s STASIS clinical trial that has commenced in Europe.
FLAGSTAFF, Ariz. & MIAMI--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today announced that the FDA has approved the use of the new GORE® Septal Occluder for inclusion in the Gore REDUCE Clinical Study. Gore is introducing this latest technology in its Gore REDUCE Clinical Study for prevention of recurrent stroke in patent foramen ovale (PFO) patients. The study is designed to demonstrate that PFO closure with the Gore device plus antiplatelet medical management reduces the risk of recurrent stroke or imaging-confirmed Transient Ischemic Attack (TIA) when compared to antiplatelet medical management alone. The prospective, randomized, multi-center, multi-national trial includes up to eighty investigational sites in the US, Europe and Canada.
OrbusNeich has announced that a study published in the World Journal of Cardiovascular Diseases shows that, prior to drug eluting stent implantation, the Scoreflex coronary dilatation catheter is associated with equivalent acute stent expansion and less in-stent late loss vs. a non-compliant balloon.
On 19 October, Gore reported the first patient enrolled in the US Gore Septal Occluder clinical study evaluating the safety and efficacy of the new Gore Septal Occluder in the treatment of percutaneous, trancatheter closure of ostium secundum atrial septal defect (ASD). Gore announced that the patient was successfully treated at Duke University Medical Center in Durham, North Carolina, USA, by John Rhodes, chief of the Congenital Heart Center; and Mandy Green.
The US Food and Drug Administration (FDA) has given Loma Vista Medical clearance for its True Dilatation Balloon Valvuloplasty Catheter. The device, which is also CE-marked, features a balloon specifically designed to prevent balloon ruptures in transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty (BAV) procedures.
A report from the CathPCI registry, a data registry that includes information from 85% of the US heart catheterisation laboratories, has shown data on the current practice of invasive cardiology in the United States.
(Reuters) - St. Jude Medical Inc (STJ.N) warned Wall Street that U.S. health regulators might issue a warning letter about one of its factories in California as it reported another weak quarterly performance and reeled in its outlook.
Infraredx and Philips have announced they have signed a joint development and collaboration agreement that is focused on integrating Infraredx’s true vessel characterisation (TVC) Imaging System with Philips’ Allura Xper catheterisation (cath) lab imaging systems. This collaboration is intended to enable seamless access to the TVC Imaging System with Philips’ Allura X-ray systems.
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