With a green light shining brightly from the FDA W. L. Gore & Associates (Gore; Flagstaff, Arizona) is set to take a huge chunk of the peripheral arterial disease (PAD) market with its latest stent graft offering, the Gore Viabahn Endorposthesis.
It's not so much an outright approval of the device as it is a modification according to the company. The device is 9 mm to 13 mm, as previous iterations of it were from 5 mm to 8 mm in size. Additional modifications to the large diameter Gore Viabahn Endoprosthesis include radial device expansion, a contoured proximal edge and a lower profile that is now available for most sizes.
"We're very pleased with the FDA's decision and this is something that we've worked long and hard on obtaining," Chris Tieché Product Specialist of W.L. Gore Associates told Medical Device Daily.
Tieché went on to say that the device is the only stent-graft approved by the FDA for the treatment of patients suffering from peripheral arterial disease in superficial femoral artery (SFA) lesions and iliac artery lesions.
The Gore Viabahn Endoprosthesis family of devices is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The product's flexibility enables it to traverse tortuous areas and to conform to the complex anatomy of the artery.
"The self-expanding, covered, Gore Viabahn Endoprosthesis offers elegant and versatile endovascular solutions to difficult vascular problems," said Michael Silva, Jr., MD, Professor of Vascular Surgery, Professor of Radiology and Director of the Texas Vascular Center, University of Texas Medical Branch (Galveston, Texas).
He added that "the latest improvements to the Gore Viabahn Endoprosthesis with Heparin Bioactive Surface, including smaller delivery profile and 0.035" wire compatibility for the larger diameter endografts, will allow us to easily deliver the larger devices to more locations. Treating difficult vascular problems requires good skills and good equipment. We just got some cool new enhancements to our toys."
Tieché said that another unique offering is the "heparin coated surfaced" which could manipulate surrounding tissue.
"This is certainly a natural evolution and more medical devices are going to have to go that route in the future," Tieché told MDD.
The original device configuration in 6 mm to 8 mm sizes was initially approved by the FDA in 2005 for treating PAD in the SFA.
Back 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 mm to 13 mm for the indication of improving blood flow in patients with symptomatic peripheral artery disease in iliac artery lesions.
Last month, Gore said 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.
But the origin of the Viabahn system dates back to the late 1990s and a company called Prograft Medical (Sunnyvale, California). Before Gore acquired it, Prograft had developed a trachea bronchi device that would eventually evolve into the Viabahn.
Since that time Gore has released hundreds of products and since this spring, several of the products have made med-tech headlines.
In May, the company reported one of the first clinical uses of the 31 mm diameter version of the Gore Excluder AAA endoprosthesis since its approval in March 2009 by the FDA. The device was used to treat a patient with abdominal aortic aneurysm. The device is an endovascular graft and stent combination that isolates the aneurysm from systemic blood flow.
It is inserted through a small incision in the patient's leg using a catheter-based delivery technique to treat the AAA (Medical Device Daily, May 18, 2009) and a few scant days prior to news on the Excluder AAA; the company said it had developed the Gore Adsorbent Filter. The filter contains activated carbon media and Gore's expanded polytetrafluoroethylene membrane. The company says the filter delivers a combination of adsorption, high airflow, and liquid resistance.
"The recent modifications to the Gore Viabahn Endoprosthesis device underscores our commitment to continually provide our customers with next-generation, innovative products for the treatment of Peripheral Arterial Disease (PAD) in the iliac artery," said Erin Hutchinson with the Gore Peripheral Vascular Business. "Gore strives to be at the forefront of technology innovation and we're pleased to provide interventionalists with an improved version of the large diameter devices that will allow more patients to receive safe and effective interventional therapies for the treatment of PAD in iliac arteries."