Jetstream G3 SF
Pathway Medical Technologies Inc. (Kirkland, WA) announced that the US Food and Drug Administration has granted the company 510(k) clearance to market its Jetstream G3 SF (small fixed), the newest version of its peripheral revascularization catheter for treating peripheral vascular disease. The smaller size, fixed cutter and longer catheter length make it an ideal option for treating blockages below the knee.

“The Jetstream G3 SF gives me a new tool in my arsenal to treat a wide range of peripheral vascular disease patients, including those with blockages in smaller arteries below the knee,” said Dr. Malcolm T. Foster III, research director at East Tennessee Heart Consultants and physician at Mercy Medical Center West in Knoxville, Tennessee. “In particular, patients with diabetes have often faced the threat of amputation due to poor circulation in the extremities. With Jetstream, some of these patients now have a viable option for treating critical limb ischemia and saving their limb.”

Quick-Close Vascular Closure Device
Quick-Close (Interventional Therapies, Westport, CT) is a vascular closure device that received US Food and Drug Administration premarket approval in April 2010. The product previously received CE Mark approval in Europe. Quick-Close is approved for use in femoral arteriotomy closure in both diagnostic and interventional endovascular procedures using 5- to 8-F sheaths. According to the company, Quick-Close is designed to allow for simple, verifiable, and consistently safe vascular closure. The device enables the user to significantly reduce time to hemostasis and time to ambulation with the additional safety of verifiable suture closure.

In the pivotal trial involving 367 patients, the median time to hemostasis was 1 minute. Quick-Close has no intraluminal moving parts, thereby reducing the potential for occlusion or other device-related complications. In addition, the device has been engineered to allow the user to have a safety check at each step to ensure proper percutaneous placement and function.

Arstasis One Femoral Artery Access System
The US Food and Drug Administration recently granted United States marketing clearance to the Arstasis One femoral artery access system (Arstasis, Inc., San Carlos, CA). According to the company, the device allows physicians performing angiographic procedures to create a shallow-angled needle pathway through the wall of the femoral artery for placement of an introducer sheath. At the end of the procedure, when the sheath is withdrawn, the shallow-angled pathway collapses from the normal pressure of the patient's femoral artery blood flow from below and approximately 4 minutes of mild, nonocclusive pressure from above, resulting in quick cessation of bleeding and a positive experience for the clinician and patient alike. According to the company's Web site, “The resulting closed access site provides vascular closure device–like profiles in time to hemostasis and time to ambulation in diagnostic patients.”

Endologix PowerFit Aortic Extension
Endologix, Inc. (Irvine, CA) recently announced US Food and Drug Administration approval of the PowerFit Aortic Extension, which is indicated for the treatment of abdominal aortic aneurysms (AAAs) in use with the company's existing product line, the IntuiTrak endovascular system. The PowerFit aortic extension features an independent stent design that offers 24 circumferential contact points.

“The new PowerFit line of aortic extensions enhances our expanding product offering, with the added benefits of improved visibility during placement and design features that facilitate anatomical conformability and sealing. In conjunction with anatomical fixation using the IntuiTrak endovascular system, and our recently launched new sizes, Endologix offers a comprehensive product offering for the treatment of AAA,” the company stated.

The PowerFit aortic extension is available in a range of sizes indicated to treat aortic necks ranging from 18 to 32 mm in diameter and are offered in lengths up to 120 mm.