November 14, 2011 – Medrad Inc. announced that five-year data from the THUNDER trial [1] demonstrated a 59 percent relative reduction in target lesion revascularization (TLR) rates in popliteal arteries of patients with peripheral arterial disease (PAD) treated with the Cotavance drug-eluting balloon with Paccocath technology compared to standard balloon angioplasty (POBA). Additionally, for patients requiring TLR, the average time to revascularization before TLR was extended by 448 days in patients treated with the Cotavance catheter, which is available in Europe, but not yet approved in the United States. Medrad is currently moving forward with the investigational device exemption (IDE) process as one of the steps in gaining U.S. Food and Drug Administration (FDA) approval for Cotavance product in the United States.
November 14, 2011 – OrbusNeich announced the introduction of the Combo dual therapy stent during a breakfast symposium chaired by Martin B. Leon, M.D., professor of medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York, at Transcatheter Cardiovascular Therapeutics (TCT) 2011 in San Francisco.
November 14, 2011 — A clinical trial of patients with restenosis in drug-eluting stents (DES) in native coronary arteries found treatment with paclitaxel-coated balloon angioplasty demonstrated superior results over plain old uncoated-balloon angioplasty (POBA). Results from the PEPCAD-DES clinical trial were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
SPONSORED CONTENT — Studycast is a comprehensive imaging workflow system that allows healthcare professionals to work ...
November 14, 2011 – The TWENTE clinical trial, which compared Resolute versus Xience V drug-eluting stents in a real-world population established non-inferiority between the two stents as measured by the primary endpoint: target vessel failure (TVF) at one year. Both stents also demonstrated low rates of stent thrombosis. Trial results were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
November 14, 2011 — Everist Genomics announced plans to commercialize its CardioDefender diagnostic system. It is the first U.S. Food and Drug Administration (FDA)-approved and CE mark-registered smartphone echocardiogram (ECG) system to provide hospital-quality heart rhythm monitoring outside of the hospital setting. The system incorporates several capabilities enabling physicians to diagnose and treat potentially life-threatening arrhythmias that might otherwise be missed.
November 14, 2011 – The American Society of Echocardiography (ASE) reported that the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has recognized the value of contrast agents in echocardiography and made very positive revisions to the U.S. label for Definity, an ultrasound contrast agent produced by Lantheus Medical Imaging.
Providing exceptional cardiovascular care for patients to achieve the best possible outcomes is the number one goal for ...
November 14, 2011 – ProTron Technologies announces a new approach to early detection of aneurysms in vascular systems through the patented Stethotron Cerebral Stethoscope.
November 14, 2011 — Edwards Lifesciences Corp. announced data were presented on the quality of life impact and cost effectiveness of transcatheter aortic valve replacement (TAVR) were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The data focused on patients at high risk for traditional open-heart surgery. TCT was sponsored by the Cardiovascular Research Foundation.
November 11, 2011 — Maquet Cardiovascular announced U.S. Food and Drug Administration (FDA) 510(k) clearance and CE mark for its new Cardiosave intra-aortic balloon pump (IABP). The announcement came at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco. The system is expected to be commercially available in the United States in January 2012.
Cardiac positron emission tomography (PET) is growing in popularity among cardiologists because it provides the ability ...
November 11, 2011 – Boston Scientific reported results from the EVOLVE first human use trial demonstrating the non-inferiority of the Synergy everolimus-eluting stent system compared to the Promus Element everolimus-eluting stent system in treating de novo coronary artery lesions. The trial provided 30-day clinical and six-month angiographic primary endpoint data evaluating the safety and effectiveness of the bioabsorbable polymer-coated Synergy stent. Results were presented today during a late-breaking clinical session by professor Ian T. Meredith, M.B.B.S., Ph.D., director of MonashHeart, Monash Medical Centre, Melbourne, Australia, and principal investigator of the trial, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.
November 11, 2011 – Biosensors International Group announced two-year results from the BioFreedom first-in-human trial, which showed similar clinical outcomes between BioFreedom, a polymer-free, drug-coated stent (DCS), and Boston Scientific’s Taxus Liberté drug-eluting stent (DES). There was no evidence of stent thrombosis in either trial arm. Results were presented by Professor Eberhard Grube, University Hospital Bonn, Germany, at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
November 11, 2011 — The 30-day results from the 8,500+ patient ADAPT-DES registry were presented at the 2011 TCT conference in San Francisco. Patients with high platelet reactivity, as measured by the Accumetrics VerifyNow P2Y12 test, exhibited an approximately four times higher rate of stent thrombosis than patients without high platelet reactivity.
When performing radiofrequency (RF) ablation to treat cardiac arrhythmia, medical professionals must balance the safety ...
November 10, 2011 — The results of an analysis of 149 EVEREST II high surgical risk patients with significant mitral regurgitation (MR) of functional etiology were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2011. Michael Argenizano, M.D., chief of adult cardiac surgery for New York-Presbyterian Hospital/Columbia University Medical Center made the presentation.
November 10, 2011 — Edwards Lifesciences Corp. announced the U.S. Food and Drug Administration (FDA) conditionally approved the addition of a second treatment group to the PARTNER II Trial. The trial is studying the company's next-generation Edwards Sapien XT transcatheter heart valve.
November 10, 2011 – GE Healthcare will feature several new products and solutions at the Cardiovascular Research Foundation’s 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.