Healthcare Industry News: VIABAHN Endoprosthesis
News Release - February 25, 2008
First Patient Enrolled in Study Evaluating Performance of Spectranetics Laser Ablation Followed by GORE VIABAHN(R) Endoprosthesis with Heparin Bioactive SurfacePhysician-sponsored study to examine combination therapy for lower limb in-stent restenosis in patients treated for Peripheral Vascular Disease
FLAGSTAFF, Ariz. & COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--W. L. Gore & Associates, Inc. (Gore) and Spectranetics (NASDAQ: SPNC ) today announced the enrollment of the first two patients in the VIVA II: SALVAGE Trial. The patients were treated by Dr. Eric Dippel at Midwest Cardiovascular Research in Davenport, Iowa. The physician-sponsored SALVAGE Trial, is designed to evaluate the safety and performance of the GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface and the Spectranetics TURBO-Booster® and TURBO elite® laser catheter with the CVX-300® Excimer Laser System for the treatment of peripheral vascular disease (PVD) in the superficial femoral artery (SFA). Specifically, the study will evaluate the effectiveness of this combination therapy as a treatment for patients with chronic lower-limb ischemia associated with femoro-popliteal in-stent restenosis.
Restenosis is a re-narrowing or blockage of an artery at the same site where treatment, such as a stent procedure, has already taken place. The SALVAGE Trial will evaluate patients experiencing in-stent restenosis after being treated for PVD, also called Peripheral Arterial Disease (PAD), which affects as many as 12 million Americans. The disease manifests as a buildup of plaque in the wall of an artery and results in either narrowing or blocking of the artery, limiting blood flow to the limbs.
The SALVAGE Trial (a proSpective, multicenter triAL to eValuate the safety and performance of Spectranetics’ laser with adjunct PTA and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface for the treatment of SFA in-stent restenosis) is a physician-sponsored investigational device exemption (PS-IDE) study by the Vascular Interventional Advances (VIVA) physicians that is co-funded by Gore and Spectranetics. This prospective, multi-center trial has a primary endpoint of 12-month patency measured by ultrasound. Up to 100 patients with in-stent restenosis of the SFA will be enrolled in the SALVAGE Trial.
“The enrollment of the first patient in the SALVAGE Trial marks the beginning of an extensive investigation. We are optimistic this study will lead to the availability of an effective, minimally-invasive treatment option for those suffering from in-stent re-stenosis,” said Eric Dippel, M.D., Midwest Cardiovascular Research.
“The SALVAGE Trial provides a unique and rare opportunity to study two ground-breaking technologies for the treatment of a condition that affects about 20 to 30 percent of patients treated with stents for PVD in the SFA,” said John Laird, M.D., University of California, Davis and Principle Investigator for the SALVAGE Trial. “We expect that this landmark study will provide the medical community with critical insight into the possibilities of combining laser atherectomy and heparin-bonded stent grafts in the treatment of in-stent restenosis.”
The Spectranetics TURBO-Booster, cleared by the Food and Drug Administration (FDA) in 2007, functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee. The TURBO-Booster combined with Spectranetics’ FDA-cleared TURBO elite laser catheters allows for removal of large amounts of plaque material above the knee within the SFA and popliteal arteries.
The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is the only stent graft approved for treating PVD in the SFA. The device was approved by the FDA in 2007 and combines Gore’s proprietary heparin surface treatment with the GORE VIABAHN Endoprosthesis. The excellent flexibility of the GORE VIABAHN Endoprosthesis enables it to better traverse tortuous areas of the SFA and conform more closely to the complex anatomy of the artery.
Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The Company's disposable catheters use high-energy “cool” ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads. For more information, visit www.spectranetics.com.
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery. Gore was recently named the 10th best company to work for in America by Fortune.
For more information, visit http://www.goremedical.com.
GORE and VIABAHN® are trademarks of W. L. Gore & Associates. CVX-300, TURBO-Booster, and TURBO elite are trademarks of The Spectranetics Corporation. AL0789-EN1 FEBRUARY 2008
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