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New balloon catheters, wire guides target PAD
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Several interventional products designed to treat peripheral artery disease were formally launched at the Vascular Interventional Advances 2009 meeting in Las Vegas.
The devices, all part of Cook Medical’s Leg Therapy Program targeting the iliac, femoral, popliteal and infrapopliteal vascular systems, included the Approach CTO micro wire guide, the Advance low profile PTA balloon dilatation catheters and the Zilver 518 RX vascular self-expanding stent.
Advance PTA balloon catheters
The Advance low profile PTA balloon catheters are indicated for use in patients with femoral, iliac and renal artery lesions and are also indicated for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Each catheter is compatible with a guide wire of corresponding size, with the Advance 14LP using a 0.14-inch guide wire, the Advance 18LP using 0.18-inch guide wire and the Advance 35LP using a 0.35-inch guide wire. The Advance 35LP, according to a Cook press release, is designed to treat common above-the-knee blockages. The Advance 18LP is designed for use in the femoral and popliteal region of the leg, and the Advance 14LP is recommended for use in more torturous vessels such as the popliteal and infrapopliteal arteries in the lower leg.
The catheter balloons feature low crossing profiles and offer compatibility with smaller sheaths. Additional features include a thermal setting that allows more effective rewrap and sheath pull-back, as well as a double-lumen shaft of nylon-blend material that allows reduced inflation/deflation time and reduced kink resistance.
Non-balloon catheter products
Cook also launched three other non-balloon catheter products at the meeting, including the Approach CTO wire guide, the Approach Hydro ST wire guide and the Zilver 518 Rapid Exchange self-expanding stent.
Consisting of a polytetrafluoroethylene-coated stainless steel wire with a stainless steel and platinum distal tip, the Approach CTO wire guide is indicated for use in the delivery of percutaneous catheters into the CV system. The maximum outside diameter of the Approach CTO wire is 0.0142 inches and is available in lengths of 135 cm, 190 cm and 300 cm. The Approach Hydro ST wire guide, nearly identical in design and dimension to the Approach CTO wire guide, is designed to facilitate the delivery of percutaneous catheters to the peripheral vasculature instead of the CV system. Both wires are intended for one-time use.
The Zilver 518 Rapid Exchange vascular self-expanding stent is designed as an adjunct PTA and is indicated for the treatment of symptomatic vascular disease of iliac arteries up to 100 mm in length and with a reference vessel diameter of between 5 mm and 9 mm. The self-expanding nitinol stent is fitted with multiple gold markers on either end to facilitate placement in the lumen. The stent can be delivered using a 0.018-inch wire guide and is recommended for use with a 5-French sheath with a 7-French guiding catheter. The stent is available in a variety of combinations of lengths (20 mm, 30 mm, 40 mm, 60 mm or 80 mm) and diameters (between 6 mm and 10 mm).
“People tend to associate leg conditions exclusively with injury and fail to recognize the importance of maintaining the overall health of the legs until it is too late,” Robert Lyles, vice president of Cook Medical’s peripheral intervention division, said in a press release. “By introducing these six products to the vascular medicine and interventional communities, we are giving vascular interventionalists six tools to improve their patient outcomes and deliver actionable solutions to those who need them most.”