Misago RX Self-Expanding Peripheral Stent
Terumo Corporation has recently received PMA approval for their uniquely designed Misago RX self-expanding peripheral stent indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the superficial femoral artery and/or proximal popliteal artery with reference vessel diameters ranging from 4 mm to 7 mm and lesion length up to 150 mm.
The Misago peripheral stent’s absence of spine-link stress points and nonlongitudinal connections provides flexibility, crush resistance, fracture avoidance, conformability, and optimal radial force. The catheter design leverages Terumo’s long interventional experience and provides predictable navigation through tortuous anatomy and, in combination with the palm-sized handle, enables control and accuracy of deployment. In one of the first Harmonization by Doing initiatives between the United States and Japan, OSPREY (Occlusive/Stenosis Peripheral Artery Revascularization Study) resulted in strong clinical data at 12 months. The Misago peripheral stent has received regulatory approval in the EU, Japan, Australia, Latin America, and the United States, with over 5,000 patients studied in clinical trials over 7 years.
RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.
FirstChoice PTA Dialysis Access Dilatation Catheter
DirectAccess Medical has received US FDA clearance for the full line of FirstChoice UHP PTA (percutaneous transluminal angioplasty) catheters for dialysis access. The FirstChoice UHP PTA catheters are designed to treat all obstructive lesions that present in dialysis access related to native or synthetic arteriovenous dialysis fistulae. The catheters are also indicated for the peripheral vasculature to include the femoral, iliac, and renal arteries.
“The FirstChoice UHP PTA balloons have a unique applicability in access due to the combination of strength, contouring inflation, and trackability,” said
John R. Ross, MD, of the Dialysis Access Institute in Orangeburg, South Carolina, in the company’s press release. “The contouring effect is the forte of the longer length balloons when used in the cephalic arch. The smaller-diameter balloons track through severe arterial angulations while still allowing for the delivery of ultra-high-pressure dilatation. I believe these balloons are the safest products available for juxta-anastomosis dilatation.”
AngioSculpt PTA Scoring Balloon Catheter (7- and 8-mm diameter)
The AngioSculpt PTA scoring balloon catheter 7- and 8-mm diameter, which received FDA clearance in April 2015, treats the narrowing of the arteriovenous fistula or graft, a surgically created conduit between the artery and vein.
The product’s innovative nitinol scoring elements provide unique circumferential scoring, leading to precise and predictable luminal enlargement across a wide range of lesion types. It is designed to minimize geographic miss through its unique anti-slip capability.
The AngioSculpt PTA scoring balloon catheter 7- and 8-mm diameter assists physicians with a difficult patient set, specifically targeting lesions in the hemodialysis access that are resistant to PTA. Spectranetics plans to study whether AngioSculpt will decrease frequency of treatment cycles with this advanced PTA technology.
The Pure platform from Siemens Healthcare is designed to simplify the adoption and utilization of advanced features on Siemens’ Artis zee, Artis Q, and Artis Q.zen angiography systems. The Pure platform adds smooth use to existing smart technologies while maintaining high standards in image quality and dose reduction. For 3D acquisitions, the 3D Wizard feature enables the user to simply click on the desired resultant image type from multiple model images for each part of the body. The 3D Wizard automatically predefines all necessary acquisition parameters and workflow steps—as well as recommendations regarding injector settings—to create a 3D image. The QuickZoom feature allows physicians to click on the point of interest on syngo DynaCT images, which is then locked automatically into the center of the image while rotating the 3D dataset or adjusting the zoom factor with a simple joystick motion. The syngo 2D/3D Fusion feature enables fusion of a preprocedural volume—CT, magnetic resonance imaging (MRI), or positron emission tomography (PET)—utilizing just two fluoroscopic images for live image guidance.