On 20 December 2012, Svelte Medical Systems announced treatment of the first patient in the ACES (Acrobat coronary stent system effectiveness European study) clinical trial by Victor Legrand, at CHU Liege in Liege, Belgium. ACES is a randomised, controlled study designed to demonstrate the positive clinical benefit and impact on resource utilisation of the Svelte Acrobat Integrated Delivery System (IDS) compared with conventional coronary stent devices in patients with lesions eligible for direct stenting. Up to 300 patients will be enrolled in the study at 12 sites in France, Belgium and Spain.
St Jude Medical announced on 18 December 2012 the first patient enrolment in its ILUMIEN I clinical study. This observational study is designed to show the optimal way optical coherence tomography (OCT), combined with the St Jude Medical PressureWire Aeris, a wireless interventional tool that measures fractional flow reserve (FFR), can guide stent implantation in patients with coronary artery disease.
Hiroki Mizoguchi, Division of Cardiology, National Hospital Organization Okayama Medical Center, Okayama, Japan, and colleagues have refined balloon pulmonary angioplasty for the treatment of inoperable patients with chronic thromboemobolic pulmonary hypertension (CTEPH).
Colibri Heart Valve, LLC has announced that it has successfully completed the first clinical use of the company’s proprietary transcatheter aortic heart valve. The Colibri transcatheter aortic valve implantation (TAVI) system is the world’s first and only low profile, 14 French pre-mounted, pre-crimped, and pre-packaged, ready-for-use, TAVI system.
By Cosmo Godino. Coronary chronic total occlusions (CTOs) remain a technical challenge and an unresolved clinical dilemma, even after numerous successes and rapid progression in the field of interventional cardiology. As shown by registry-based studies, the rationale behind CTO revascularisation is that of it provides improved survival and quality of life. However, until now there is no evidence regarding which category of patients benefit most from CTO revascularisation and conversely, which subgroups of not revascularised patients are at highest risk of future cardiac events. Moreover, the lack of a true randomised controlled trial with a medically treated control group raises the question of whether the survival benefit demonstrated with successful percutaneous coronary intervention (PCI) is, in fact, related to beneficial effects of opening a chronically occluded vessel versus potential harm conferred to those with CTO-PCI failed.
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.
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