Invatec Introduces Products at CIRSE Meeting

September 21, 2009—Invatec, S.p.A. (Roncadelle, Italy) announced three European market product launches at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2009 scientific meeting in Lisbon, Portugal.

First, Invatec announced the availability of Reef HP (high pressure), a percutaneous transluminal angioplasty balloon catheter for use in all peripheral high-pressure dilatation procedures. The company stated that the lesion-specific design of the balloon material is useful in hard-to-dilate situations. Available in variable shaft lengths, the Reef HP is suited to both arteriovenous shunts (50-cm shaft) and peripheral applications (80-cm/120-cm shaft). The Reef HP balloon is made from Invatec's Flexitec XF, a durable material with a working pressure range of up to 22 bar for complete control during high-pressure procedures. It is also a low-compliant balloon for a uniform dilatation force and strong shape retention to dilate resistive lesions with greater success and extreme stability, the company stated.

Next, Invatec announced the launch of the Maris Plus self-expanding peripheral stent system specifically designed for the iliac artery. The Maris Plus stent has a lesion-specific design with 30- to 100-mm lengths and 9- to 12-mm diameters to meet the clinical requirements of the iliac region. The stent geometry allows for increased stability in the hip while maintaining flexibility. Additionally, larger and fully integrated tantalum markers greatly enhance visibility. The Maris Plus optimizes flexibility and ease of use for the interventionist, Invatec stated.

Finally, Invatec introduced the FiberNet distal embolic protection system (EPS) for carotid artery stenting. The three-dimensional EPS features a low crossing profile (0.031 inch) for use in vessels ranging from 3.5 to 7 mm. The company stated that the FiberNet is also usable in complex vasculature formations, captures microemboli as small as 40 µm via specially shaped PET (polyethylene terephthalate) fibers, and can aspirate these emboli from the body, allowing for safe and easy retrieval. The FiberNet is manufactured by Lumen Biomedical, Inc. (Plymouth, MN) and is distributed worldwide by Invatec through an agreement announced in January 2009.

The FiberNet EPS received FDA clearance in November 2008 for the treatment of patients receiving endovascular intervention for carotid artery disease. The product has also received CE Mark approval for use during carotid and saphenous vein graft procedures. The FiberNet EPS was evaluated in the EPIC multicenter clinical trial during carotid artery stenting of 237 high surgical risk patients with critical artery stenosis demonstrating a 30-day stroke rate of 2.1%.

"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 Subbarao Myla, MD, national principal 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."