According to the Biosensors, LEADERS FREE is the world’s first prospective, randomised double-blind trial exclusively involving patients at high risk of bleeding. The study has been designed to investigate whether BioFreedom is as safe as a bare metal stent in this patient group, and can deliver the anti-restenotic benefit of a drug-eluting stent with only a one-month course of dual antiplatelet therapy (DAPT).
Matthew Gillespie, Children’s Hospital of Philadelphia, Philadelphia, USA, and others reported in Circulation: Cardiovascular Interventions that transcatheter pulmonary valve implantation (TPVI) with the Melody valve (Medtronic) may be an effective treatment option for patients with failed bioprosthetic valves.
The CUPID Phase 2b (Calcium up-regulation by percutaneous administration of gene therapy in cardiac disease) trial is a multinational, multicentre, double-blind, placebo-controlled, randomised study of a single intracoronary administration of 1x10(13) DRP MYDICAR vs. placebo added to an optimal HF regimen. The first patient was dosed in August, 2012 in the United States and, according to the company, the trial will enrol approximately 200 patients in up to 50 international sites.
LAKE OSWEGO, Oregon, December 17, 2012—BIOTRONIK, a leading manufacturer of innovative medical technology, announced that the first implant has taken place in the BIOHELIX-I trial in the United States. The BIOHELIX–I trial is set to evaluate the safety and performance of the PRO-Kinetic Energy coronary, bare-metal stent. The first implant was successfully performed by Dr. H. Barrett Cheek, of Carolina Cardiology Cornerstone, at High Point Regional Hospital in High Point, North Carolina.
WAYNE, N.J., Dec. 13, 2012 /PRNewswire/ -- MAQUET Cardiovascular, the leader in intra-aortic balloon (IAB) therapy, today announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) recently voted to support the Agency s reclassification of intra-aortic balloon pump (IABP) devices for certain indications to Class II (general controls and special controls) from Class III (general controls and pre-market approval). Those indications that received a recommendation to be reclassified to a Class II designation include acute coronary syndrome, complications of heart failure of both ischemic and non-ischemic etiologies, and cardiac and non-cardiac surgery.
A study published ahead of print in the Journal of the American College of Cardiology indicates that the rates of readmission following axial flow left ventricular assist device (LVAD) implantation decrease during the first six months and thereafter stabilise.
The first patient has been enrolled in the EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the Synergy Stent System (Boston Scientific) and support US Food and Drug Administration (FDA) and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.
Cardiovascular Systems has announced it has completed enrolment in its ORBIT II clinical trial with 443 patients. ORBIT II is evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating severely calcified coronary arteries.
Results from the BELLO (Balloon elution and late loss optimization) study, published in the Journal of the American College of Cardiology, indicate that the use of a paclitaxel-eluting balloon for the treatment of de novo small vessel disease is associated with less angiographic late loss and similar rates of restenosis and revascularisation compared with a paclitaxel-eluting stent.
BioVentrix has received the CE mark for its Revivent Myocardial Anchoring System, which makes possible less invasive ventricular enhancement (LIVE), a procedure that restores the left ventricle from damage done by a heart attack to a more optimal volume and conical shape, thereby enhancing performance of the heart’s non-damaged myocardium and improving quality of life.
Thomas Pilgrim, Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland, and others reported in Circulation: Cardiovascular Interventions that intercurrent events, such as access and bleeding complications (ABC), increase the cumulative risk of stroke and death after TAVI.
SAN DIEGO, Dec. 3, 2012 /PRNewswire/ -- Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today it has signed an agreement to acquire Crux Biomedical, a privately-held company that has developed a highly differentiated inferior vena cava (IVC) filterthe Crux VCF Systemto treat pulmonary embolisms (PE s). Founded in 2004 and based in Menlo Park, California, Crux has received a CE Mark and 510(k) clearance for its Crux VCF System, an innovative IVC filter designed to facilitate bi-directional retrieval through either the femoral or jugular veins.
NATICK, Mass., Nov. 30, 2012 /PRNewswire/ -- The first patient has been enrolled in the Boston Scientific Corporation (NYSE: BSX) EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the SYNERGYStent System and support U.S. Food and Drug Administration and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions. Boston Scientific received CE Mark approval for the SYNERGY Stent System last month. The EVOLVE II clinical program is anticipated to enroll approximately two thousand patients at up to 160 sites worldwide including the United States, Canada, Europe, Australia, New Zealand, Japan, India, Brazil and Singapore. The first patient was enrolled at the Christ Hospital, Lindner Research Center in Cincinnati, Ohio. The SYNERGY Stent uses the market-leading everolimus drug and features an ultra-thin bioabsorbable polymer coating. The absorption of the polymer is completed shortly after drug elution ends at three months.
Tryton Medical has announced the completion of enrolment in the Tryton pivotal investigational device (IDE) exemption trial evaluating the Tryton Side Branch Stent.
St Jude Medical has announced the first patient implant of its 23mm Portico Transcatheter Aortic Heart Valve using the Transapical Delivery System. The transapical procedure was performed by Anson Cheung, associate professor of surgery and director of cardiac transplant at St Paul’s Hospital in Vancouver, Canada.
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