A Medical Device Daily
Invatec (Roncadelle, Italy/Bethlehem, Pennsylvania) said it has entered a worldwide distribution agreement with Lumen Biomedical (Plymouth, Minnesota) 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 device 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," Stefan Widensohler and Andrea Venturelli, co-founders of Invatec, said in a company statement.
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 company noted. 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. According to the company, the FiberNet EPS will treat vessels ranging from 3.5 mm 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," said 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%. There were no unanticipated adverse device effects, the company noted. Visible debris was observed in more than 90% of the procedures.
"We are eager to align these two companies as a new level of superior products in the endovascular market," said Matthew Ogle, Lumen Biomedical's president/CEO. "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 has a pivotal 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.
In other agreements/contracts news, The Centers for Medicare & Medicaid Services has engaged the healthcare business of Thomson Reuters in a 4-1/2 year contract to manage the implementation of the Medicare Medical Home Demonstration.
This project involves physician-based office practices delivering Medical Home services to Medicare fee-for-service beneficiaries. Medical Home practices are specially qualified to provide patient-centered, comprehensive and continuous patient care through a personal physician and the practice team.
The demonstration will be conducted in up to eight states and will involve about 400 medical practices, 2,000 physicians, and 400,000 Medicare beneficiaries. Participating practices will provide Medical Home services to patients from January 2010 through December 2012 and receive additional monthly care management fees from CMS, the agency noted.
Thomson Reuters will be responsible for recruiting and qualifying physician practices to participate in the demonstration, and for monitoring beneficiary enrollment and participation. The National Committee for Quality Assurance, under contract to Thomson Reuters, will conduct the practice application and qualification processes to certify that participating practices have core Medical Home capabilities.
Throughout 2009, Thomson Reuters will contact medical practices in the demonstration areas and, via a web site and other outreach efforts, provide physicians with information about participating in the program.
Beginning in 2010, Thomson Reuters also will facilitate a two-year beneficiary enrollment period. Beneficiaries with Medicare fee-for-service coverage who live within the demonstration locations may voluntarily participate if they have at least one qualifying chronic disease. For the duration of the project, Thomson Reuters will monitor patients' eligibility for the demonstration and visits to their Medical Home, the company said.