Healthcare Industry News: drug-eluting balloon
News Release - September 21, 2009
Invatec Announces the Worldwide Launch of FiberNet®, the Smallest Distal Embolic Protection System on the Market, at CIRSE 2009Lowest Profile, Highest Level of Performance
LISBON, Portugal, Sept. 21--(HSMN NewsFeed)--Invatec, a comprehensive innovator of interventional products, today introduced FiberNet®, a 3-dimensional distal Embolic Protection System (EPS) for Carotid Artery Stenting with the lowest crossing profile (0.031’’) and highest performance capabilities on the market, manufactured by Lumen Biomedical. FiberNet provides superior deliverability and can be used in vessels ranging from 3.5 to 7 mm.
With its unique design, FiberNet ensures excellent atraumatic wall apposition. It is also usable in the most complex vasculature formations, captures micro-emboli as small as 40µm via specially shaped PET-fibers and can aspirate these emboli from the body, allowing for safe and easy retrieval.
The FiberNet Embolic Protection System was evaluated in the EPIC Trial, a multi-center clinical study during carotid artery stenting of 237 high surgical risk patients with critical artery stenosis demonstrating a 30-day stroke rate of 2.1%, the lowest ever reported for a distal Embolic Protection Device. The FiberNet EPS captures micro-emboli to prevent fragments traveling to the brain thus reducing the risk of ischemic stroke. Andrea Venturelli and Stefan Widensohler, co-founders of Invatec commented, “We are extremely excited about bringing this advancement in embolic protection technology to the worldwide market and believe it sets a new performance standard for distal embolic protection of Carotid Artery Stenting, further reducing the risk to the patient. Our partnership with Lumen represents a tremendous opportunity to expand our position in the endovascular field.”
“The FiberNet EPS has several attributes including ease of use, low profile, and the ability to conform to an irregular surface in the vessel wall, all of which have contributed to the impressive results and safety profile that we observed in the EPIC trial,” commented Dr. Subbarao Myla, medical director of cardiovascular research and endovascular intervention at Hoag Memorial Hospital in California and national principle investigator for the trial. “The device achieved the lowest stroke rate of any filter currently available, making FiberNet a top choice for physicians, and representing the next generation in embolic protection.”
Headquartered in Italy and with manufacturing in Italy and Switzerland, Invatec is one of the world’s fastest growing companies in the design, development and production of interventional cardiology and peripheral vascular products for the treatment of coronary and peripheral arterial disease. Driven by research and technology, Invatec actively collaborates with physicians and centres of excellence to develop products that will improve life expectancy and quality of life for patients. Vertically integrated, Invatec also has the in-house ability to design, develop, manufacture and assemble its entire product offering from raw materials. As a result, the company has one of the largest therapeutic catheter product lines in the world, including 9 stent platforms, 6 angioplasty balloon platforms, 4 drug-eluting balloon platforms and accessory devices, now sold in over 70 countries.
Dedicated to "making ideas come alive," the company was founded in 1996 by Andrea Venturelli and Stefan Widensohler, and has grown to almost 1,000 employees. For more information, visit www.invatec.com.
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