PowerCross PTA Balloon
ev3 Inc. (Plymouth, MN) recently received US Food and Drug Administration 510(k) clearance for the PowerCross 0.018-inch overthe- wire (OTW) percutaneous transluminal angioplasty (PTA) dilatation catheter. PowerCross, the next generation in PTA balloon technology, delivers a balance of excellent pushability, low crossing profile, and reduced deflation times, the company stated. A strengthened catheter design provides optimal pushability, and an increased internal lumen provides greatly reduced deflation times. The PowerCross balloon is available in lengths of 20 to 200 mm on 90- and 150-cm shafts. Two additional marker bands in the center of the 150- and 200-mm length balloons provide additional visibility under fluoroscopy. The PowerCross 0.018-inch OTW PTA dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral vasculature.
Eclipse Vena Cava Filter
Bard Peripheral Vascular (Tempe, AZ) recently announced Food and Drug Administration clearance of the Eclipse vena cava filter. According to the company, the Eclipse filter combines proven performance with long-term retrievability and improved surface finish.
The Eclipse vena cava filter utilizes a conical filter design in two offset layers that effectively trap large and small emboli without compromising caval patency. A specially designed pusher wire and articulated arms promote a centered filter placement, even through tortuous anatomy. Multiple retrieval options allow for safe and easy retrieval using an endovascular snare or the Recovery Cone removal system. The unique design of elastic hooks allow for atraumatic filter removal even after extended indwell times. The Eclipse vena cava filter is currently commercially available in the United States.
VascuTrak PTA Dilatation Catheter The VascuTrak PTA dilatation catheter (Bard Peripheral Vascular, Inc., Tempe, AZ) utilizes two external wires to focus the outward dilatation force of the balloon on the lesion. This focused force allows the balloon to dilate lesions at low inflation pressures. Additionally, the design of the balloon allows it to dilate in tortuous anatomy and calcified lesions. The VascuTrak PTA dilatation catheter is offered in lengths up to 300 mm, the longest on the market.
Reef HP PTA
The Reef HP PTA balloon catheter (Invatec Inc., Bethlehem, PA) recently received US Food and Drug Administration 510(k) clearance for use in peripheral high-pressure dilatation procedures. According to the company, the lesion-specific design of the balloon is particularly useful in hard-to-dilate situations. “We often encounter calcified and resistant lesions in peripheral vessels and in hemodialysis access interventions,” commented Robert L. Vogelzang, MD, Professor of Radiology at Northwestern University Medical School and Chief of Vascular and Interventional Radiology at Northwestern Memorial Hospital. “Invatec's addition of a highpressure PTA balloon will aid in the successful treatment of these challenging lesions.” The REEF HP balloon is made from Invatec's proprietary Flexitec XF, an extremely durable material with a large working pressure range of up to 22 atm, offering excellent control during high-pressure procedures. The low-compliant balloon offers a uniform dilatation force and strong shape retention to dilate resistive lesions with greater stability and success. The balloon is now available in a wide range of sizes from diameters of 4 to 8 mm and lengths of 20 to 80 mm.
Merit Medical Systems, Inc. (South Jordan, UT) is expanding its centesis line of products with the addition of the Valved One-Step centesis drainage catheter. The catheter incorporates a self-sealing valve in the catheter hub to minimize the risk of air infiltration and fluid leakage during thoracentesis and paracentesis procedures. The patent-pending valve design may be opened with either a needle or luer fitting. When a syringe or drainage tubing is connected to the catheter, the valve fully opens to allow maximum drainage. Four large drainage holes spiral around the catheter for maximum flow. According to the company, inserting the catheter is easier with a new tapered-tip design that provides excellent transition through the skin and tissue. More accurate placement is achieved with the increased visibility of the echo-enhanced needle.