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CLINICAL&DEVICENEWS
FDA approves study of ZFEN+ for treatment of aortic aneurysms
The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+).The clinical study will assess the safety and effectiveness of the ZFEN+ in combination with the Bentley InnoMed BeGraft balloonexpandable fenestrated endovascular aortic repair (FEVAR) bridging stent graft system for patients with aortic aneurysms involving one or more of the major visceral arteries.
The ZFEN+ is predicated on the commercially available Zenith fenestrated abdominal aortic aneurysm (AAA) endovascular graft, but extends the proximal margin of aneurysmal disease that can be treated endovascularly to include patients with more complex aortic disease. For patients with complex aortic disease, the only established treatment option is open repair.
The ZFEN+ study is prospective and singlearm and includes sites in the U.S. and Europe. The FDA has approved enrollment of the first 30 patients. The primary safety endpoint is a composite measure of device technical success and procedural safety within 30 days. Likewise, the primary effectiveness endpoint is a composite measure of freedom from aneurysmrelated mortality and freedom from clinically significant reintervention through 12 months post procedure.—Jocelyn Hudson
Surmodics receives FDA approval for the SurVeil drug-coated balloon
Surmodics has announced the receipt of FDA approval for the SurVeil drug-coated balloon (DCB).
A company press release notes that the SurVeil DCB may now be marketed and sold in the U.S. for percutaneous transluminal angioplasty after appropriate vessel preparation, of de novo or restenotic lesions (≤180mm in length) in femoral and popliteal arteries having reference vessel diameters of 4mm to 7mm.
“I am excited that the Surveil DCB will be available to treat patients in the U.S.,” said Kenneth Rosenfield, MD, an interventional cardiologist at Massachusetts General Hospital in Boston, co-principal investigator of the TRANSCEND clinical trial.
“The Surveil DCB is the nextgeneration DCB as established by results from the TRANSCEND trial, which is the only head-to-head pivotal study that has been conducted versus the market-leading DCB. The Surveil DCB successfully demonstrated non-inferior safety and effectiveness at two years posttreatment with a substantially lower drug dose.” Clare Tierney creditation of training in vascular surgery that were adopted by the Royal College of Physicians and Surgeons of Canada. He co-edited the seventh and eight editions of Rutherford’s Vascular Surgery For seven years, he was editor-in-chief of SVS’ peer-reviewed scientific journal, the Journal of Vascular Surgery , and was the first Canadian to be honored with this responsibility.
As a clinical scientist, Johnston’s research greatly improved the care of patients with vascular disease, and his vascular research lab was one of the first in North America. His impact on the understanding and treatment of patients with vascular disease was unparalleled. Johnston published seminal papers detailing the results of the world’s first major prospective study of patients that established the role of balloon angioplasty of the arteries of the legs in treating patients with impaired circulation, preventing disabling pain and amputations. His research changed the way that patients with blocked arteries are treated. This procedure is now recognized internationally as the treatment of choice.
Additionally, in the late 1980s and early 1990s, Johnston led the first and largest Canadian-based multicenter study of abdominal aortic aneurysms in the world.
INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm – 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.
CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.