BETHLEHEM, Pa. & PLYMOUTH, Minn.--(BUSINESS WIRE)--Invatec, a comprehensive innovator of interventional products, today announced that it has entered a worldwide distribution agreement with Lumen Biomedical, Inc. to distribute the FiberNet® Embolic Protection System (EPS). The FiberNet EPS, which received FDA clearance in November, is indicated 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 (SVG) procedures.
“The addition of the FiberNet device to our global carotid portfolio underscores our goal to provide the most comprehensive product offering of stents and embolic protection options to physicians and patients for the treatment of carotid stenoses,” commented Stefan Widensohler and Andrea Venturelli, co-founders of Invatec.
Carotid artery disease is caused by the buildup of fatty substances and plaque. When the carotid arteries are obstructed, patients are at an increased risk for stroke, the third leading cause of death in the U.S. The FiberNet EPS captures debris released during the stenting procedure and prevents it from traveling to the brain, where it has the potential to cause a stroke.
The FiberNet system features a three-dimensional design composed of a matrix of fibers which allows for the entrapment of smaller particles and better overall capture efficiency compared to the currently available distal protection filters. The low-profile filter is mounted on a guidewire, needing no delivery system to cross the lesion. The FiberNet EPS will treat vessels ranging from 3.5 to 7 mm and its unique design ensures excellent wall apposition. After the particles have been captured, the FiberNet filter is retrieved into the retrieval catheter under aspiration and removed from the patient.
“FiberNet EPS represents the latest technology available for distal embolic protection and complements our current offerings of innovative, effective and physician-driven products,” commented Jack Springer, president of Invatec. “Our partnership with Lumen represents a tremendous opportunity to expand Invatec’s position in the endovascular field. We look forward to pursuing additional indications for FiberNet beyond carotids, including infra-inguinal and renal.”
The FiberNet EPS was evaluated in the EPIC (Evaluating the Use of the FiberNet EPS in Carotid Artery Stenting) multicenter trial, which demonstrated the lowest stroke rates of any filter currently available in the U.S. market. As part of the trial, 237 high-surgical-risk patients with a critical carotid artery stenosis received carotid artery stenting. Overall, the 30-day stroke rate was 2.1 percent. There were no unanticipated adverse device effects. Visible debris was observed in over ninety percent of the procedures.
“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, that have contributed to the impressive results and safety profile 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 represents the next generation in embolic protection.”
“We are eager to align these two companies as a new level of superior products in the endovascular market,” Matthew Ogle, Lumen Biomedical’s president and chief executive, remarks. “Invatec’s dedication to innovation parallels those of Lumen’s, together creating the opportunity to become a global leader in embolic protection.”
Invatec’s carotid portfolio consists of the Mo.Ma Proximal Protection Device and the Cristallo Ideale Carotid Stent System, both of which have received CE Marks. In the U.S., Invatec currently has a pivotal IDE (Investigational Device Exemption) clinical trial called ARMOUR underway to assess the safety and efficacy of the Mo.Ma Proximal Protection Device for use in carotid stenting with FDA approved carotid stents.
About Invatec
Invatec is a comprehensive innovator of vascular interventional products with global headquarters based in Italy. Driven by research and technology, Invatec actively collaborates with physicians and centers of excellence to develop products that will improve life expectancy and quality of life for patients. The company’s core competencies include plastic processing, metal technology and surface technology. Invatec is vertically integrated with full in-house capabilities to design, develop, manufacture and assemble the 35 product families that are offered in more than 70 countries. Dedicated to “making ideas come alive,” the company was founded in 1996 by Andrea Venturelli and Stefan Widensohler, and has grown to more than 700 employees. For more information, visit www.invatec.us.
About Lumen Biomedical
Since being founded in July 2003, Lumen Biomedical’s primary goal has been to create unique interventional devices that outperform existing technologies and can be used in virtually any anatomical area. With this goal in mind, the company has dedicated its efforts to developing and commercializing products for embolic protection and thrombus removal throughout the body. The company believes that the FiberNet® Embolic Protection System, which received FDA clearance in November 2008, will establish a new standard and confidence in embolic protection.
Contact:
For Invatec Andrea tenBroek, 781-684-0770 invatec@schwartz-pr.com
