• Vascular Specialist Newspaper
• Volume 5 - 2009
• Number 9 online
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• Number 7 online
• Number 6
• Number 5 Online
• Number 4 online
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• Number 12 online
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• Volume 4 - 2008
• Number 6
• Number 5
• Number 4
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• Number 1
• Volume 3 - 2007
• Number 6
• Number 5
• Number 4
• Number 3
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• Number 1
• Volume 2 - 2006
• Number 6
• Number 5
• Number 4
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• Number 1
• Volume 1 - 2005
• Number 2
• Number 1

Approved

Larger VIABAHN Endoprosthesis with Heparin Bioactive Surface Receives FDA Approval

W.L. Gore & Associates (Gore) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the GORE VIABAHN Endoprosthesis for device diameters 9-13 mm. The large-diameter product enables deployment on the same 0.035" guidewire and TIP to HUB direction as the 5-8 mm sizes. Additional modifications to the large diameter, self-expanding endoprosthesis include radial device expansion, a contoured proximal edge and a lower profile available for most sizes. The VIABAHN devices are constructed with reinforced, biocompatible, expanded polytetrafluoroethylene liner attached to an external nitinol stent structure. The original device configuration in 6-8 mm sizes was initially approved by the FDA in 2005 for treating PAD in the superficial femoral artery (SFA). In 2007, Gore added a 5 mm size and made modifications to the device, including reducing its profile and adding a Heparin Bioactive Surface. In 2008, Gore received approval for large diameters of the GORE VIABAHN Endoprosthesis 9-13 mm for the indication of improving blood flow in patients with symptomatic peripheral artery disease in iliac artery lesions. In June, 2009, Gore announced that the FDA approved a manufacturing change to the device in order to remove excess material at the device margin, resulting in a contoured edge at the proximal end. The device is the only stent-graft approved by the FDA for the treatment of patients suffering from PAD in superficial femoral and iliac artery lesions.

W.L. Gore & Associates

Peripherally Inserted Central Catheter that Avoids Heparin Approved

A biomimetic coating being used on a new peripherally inserted central catheter (PICC) from r4 Vascular mimics the glycocalyx layer on endothelial tissues. The company recently gained FDA clearance to launch their first catheter based on this technology, the ZeusTM Coated CT PICC, available as of June 30, 2009. A patient normally responds to the insertion of a catheter within 24 hours by developing bio-film. Thrombus can later amass on the catheter surface, within the catheter and/or it can become adherent to the vein. The thrombus can cause catheter occlusion, serve as a nidus for infection, and even dislodge, putting patients at risk for deep vein thrombosis or pulmonary embolism. Clinicians typically try to avoid thrombus occlusion by instilling heparin into catheters between uses or use a valved design. However, many patients are allergic to heparin, which can cause heparin-induced thrombocytopenia (HIT) and valves can limit placement and blood sampling, according to the company. As an alternative, the Zeus Coated CT PICC has become the first nonvalved PICC to receive FDA clearance for saline-only maintenance.

r4 Vascular

Clinical Trials

CE Mark Approval Given to Zilver PTX Stent After Clinical Trial Success

The first commercial implantations of the Zilver PTX Drug-Eluting Peripheral Stent, which is designed and approved to treat PAD affecting the superficial femoral artery (SFA), were conducted August 10 in a coordinated effort by physicians throughout Europe. The CE Mark, granted on July 24, 2009, followed the world's largest-ever clinical trial for a peripheral stent, according to Cook Medical. The trial was led by Dr. Michael Dake, medical director of the Cath/Angio Laboratories at Stanford University Medical Center, Palo Alto, California. The data published in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and Korea. Only 8 percent of all patients with de novo lesions needed a reintervention to reopen the artery in the first 12 months -- a rate significantly surpassing existing treatments for PAD in the SFA, such as balloon angioplasty and bare metal stents, according to Cook. In the United States, the Zilver PTX is an investigational device not available for sale.

Cook Medical