W. L. Gore & Associates (Flagstaff, Arizona) said the FDA has approved its EMBOLDEN study to evaluate the safety and efficacy of its Embolic Filter for neuroprotection during carotid artery stenting (CAS) in high-risk patients. The primary endpoint is a composite major adverse event rate of death, stroke, and heart attack at 30 days post-procedure, Gore said.
"In the EMBOLDEN clinical study, we will continue to advance carotid stenting and improve care for patients with carotid disease," said William Gray, MD, of Columbia University Medical Center (New York), national principal investigator for the study. "Based on the demonstrated filter efficiency of the GORE Embolic Filter, we hope to produce positive results and progress the field even further."
EMBOLDEN is a prospective, multi-center, non-randomized, single-arm study. The study will enroll about 250 patients, which is expected to take between 18 and 24 months, Donald Harkness, leader for clinical affairs stroke interventions at Gore, told Medical Device Daily.
While some patients have a relatively straight artery that virtually any embolic filter can easily be maneuvered through, Harkness said it is "not terribly unusual" to encounter some "twists and turns" in the vessel. That's where Gore believes its device will stand out against the competition, he said.
"We think that it tracks very well through tortuous anatomy," Harkness said. The difference, he noted, is in the design of the device.
"The Gore Embolic Filter enhances traditional filter designs by using a unique diamond frame to minimize the risk of emboli passing between the filter frame and the vessel wall, even in tortuous anatomy," said Mary Mulder, PhD, product specialist at the company. "To take full advantage of improved filter efficiency, the filter is designed to easily navigate tortuous vessels with small landing zones and tight curves, similar to a bare guidewire."
Gore says its Embolic Filter joins its "unique flow reversal technology" to augment its carotid embolic protection solutions.
"The Gore Embolic Filter is a promising addition to Gore's expanding carotid portfolio. Having multiple embolic protection options will allow clinicians to customize the neuroprotection decision for each CAS patient," Gray said.
Gore's medical products include vascular grafts, endovascular and interventional devices, surgical materials for hernia repair, soft tissue reconstruction, staple line reinforcement, and sutures for use in vascular, cardiac and general surgery.
Gore faces competition in the embolic protection sector from some big-name companies, including Boston Scientific (Natick, Massachusetts), Medtronic (Minneapolis), and Abbott Laboratories (Abbott Park, Illinois).
Earlier this year Medtronic received the CE mark for its Defender embolic protection filter for use during minimally invasive procedures in carotid arteries and saphenous vein grafts (SVG). Made of braided nitinol, a so-called "memory metal" that resumes its original shape upon deployment, the Defender filter has a low profile and a peel-away delivery sheath that enables physicians to maneuver the device easily across lesions to the desired location, according to the company.
When opened, the filter acts as a basket, allowing sufficient blood flow while simultaneously trapping embolic debris that may become dislodged during a stenting procedure. Without this protection, Medtronic said, embolic debris can flow into other portions of blood vessels, which can lead to stroke (Medical Device Daily, April 23, 2008).
In 2006, Boston Scientific received FDA clearance to market its FilterWire EZ embolic protection system for use in CAS procedures. The device was cleared in Aug. 2004, for use in coronary SVG interventions (MDD, Dec. 15, 2006). Like Medtronic's Defender, the FilterWire EZ system is designed to capture plaque and other embolic material that may dislodge during stent implantation and prevent it from traveling into the microvasculature where it could cause stroke or a heart attack.
One company no longer in the embolic protection sector is Kensey Nash (Exton, Pennsylvania), which last year said it would discontinue its TriActiv system platforms and its ProGuard system (MDD, July 11, 2007) due to a slow-growing market with high costs. The abandoned systems provided embolic protection similar to the Defender and the FilterWire EZ.