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.
MINNEAPOLIS – October 17, 2012 – Medtronic, Inc.’s (NYSE: MDT) Melody® Transcatheter Pulmonary Valve was awarded the Prix Galien USA 2012 for Best Medical Technology last night. The Prix Galien Award, considered the biomedical industry’s highest accolade and widely recognized as the industry’s equivalent of the Nobel Prize in medicine, recognizes the technical, scientific and clinical research skills and achievements necessary to develop innovative medicines and devices.
Stentys has announced that one-year interim results from the APPOSITION III study will be presented during the Transcatheter Cardiovascular Therapeutics (TCT) conference (Miami, USA, 22–26 October).
MiCardia has announced that a scientific presentation and a live procedure with the enCorSQ Mitral Valve Repair System were presented at the 2nd Mitral Days Heart Surgery Symposium in Stuttgart, Germany to 200 cardiac surgeons and other professionals.
On 1 October 2012,Biosensors International Group and Terumo Corporation announced an extension of their existing licensing agreements, under which Terumo may continue to incorporate BioMatrix technology in the production, marketing and selling of Terumo’s drug‐eluting stent systems in markets worldwide, outside of the United States.
Svelte Medical Systems announced on 10 October 2012 the appointment of Jack Darby to the position of president and chief executive officer. Mark Pomeranz will continue to play a key leadership role at Svelte, serving as chief operating officer.
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