August 27, 2008 - XDx Inc. said today it received market clearance from the FDA for AlloMap Molecular Expression Testing, a noninvasive, multi-gene molecular diagnostics blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing.

XDx is the first U.S. molecular diagnostics company to obtain FDA clearance of an in vitro diagnostic multivariate index assay (IVDMIA) for use in transplant management.

Aug. 27, 2008 — Electrocardiographically gated 64-multidetector row coronary computed tomographic angiography (CCTA) was 99 percent as effective in ruling out obstructive coronary artery stenosis as the more expensive and invasive coronary angiography traditionally used by physicians, according to a multi-center study on the accuracy of cardiac imaging technology.

August 27, 2008 - Stereotaxis Inc. announced yesterday the FDA clearance of its magnetically tipped PowerAssert radiofrequency (RF) guidewire to cross chronic total occlusions (CTOs) in the peripheral vasculature.
Occluded or blocked arteries occur in patients with advanced peripheral arterial disease (PAD), and if left untreated can result in ulcerations and gangrene as well as significantly increased risk of limb loss and death. Eight to twelve million people have PAD, according to the American Heart Association.

Stentys, a French-based company, will feature its bifurcated stent at TCT 2008.

Terumo Interventional Systems will feature its Runthrough NS coronary guidewire at TCT 2008.

The Runthrough NS reportedly features exceptional tip shape retention, excellent guide and device support and aids vessel selection and lesion crossing. It also features DuoCore Technology and allows for multi-vessel procedures with one wire.

Terumo will also feature its line of peripheral (0.032 – 0.038-inch) and small vessel (0.018-0.025-inch) guidewires.

ProSolv CardioVascular, a FUJIFILM company, recently released ProSolv CardioVascular 4.0, a new software release featuring a Web-based application for full viewing and reporting capabilities using Web communication protocols, secured via SSL, in addition to a Web URL single-click application download and installation for easier deployment.

Other enhancements include new advanced clinical tools to further aid the diagnostic process, and the full integration to FUJIFILM Medical Systems’ Synapse PACS.

August 26, 2008 - Corgenix Medical Corp. announced its collaboration with BG Medicine whereby Corgenix' AtherOx products will be included in studies conducted by BG Medicine to predict near-term risk of first myocardial infarction (MI).

August 26, 2008 - Cook Medical today said 200 medical centers in the U.S. have adopted its EVOLUTION Mechanical Dilator Sheath technology, a new tool designed to remove faulty, ineffective leads in patients with cardiac pacemakers.

August 26, 2008 - Alsius Corp., manufacturer of intravascular temperature management (IVTM) therapies, today said the FDA granted 510(k) clearance to market its Solex heat exchange catheter.

Solex is a new catheter offering maximum heat exchange power from a standard neck insertion, while providing triple lumen central venous access, the company said.

August 26, 2008 - In a major landmark for advanced interventional technology to treat aortic disease, the Zenith Branch Iliac Endovascular Graft has been used to treat the world’s 1,000th patient undergoing endovascular treatment for an aorto-iliac or iliac aneurysm.

Dr. Ferdinand Serracino-Inglott, one of only 200 vascular surgeons performing this type of surgery in Europe, carried out the minimally invasive endovascular procedure at Manchester Royal Infirmary, Manchester, U.K. The stent-graft used in this procedure was manufactured by Cook Medical.

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