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.

November 14, 2011 – Boston Scientific welcomed positive outcomes from the COBRA clinical trial, which evaluated post-dilation of nitinol stents using CryoPlasty therapy with the PolarCath peripheral dilatation system compared to stenting with conventional balloon angioplasty in patients with diabetes presenting with blockages of the superficial femoral artery (SFA). The trial was funded through an unrestricted grant from Boston Scientific.

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 – 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.

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