Two new studies in Europe and the US are to assess the FiberNet Embolic Protection System (Lumen Biomedical). Professor Michel Henry of Nancy, France was the Principal Investigator of the initial NET/PV (Novel Embolic Protection Trial/Peripheral Vasculature) study with the device. Professor Henry successfully treated a total of 41 patients with the FiberNet system at several European centers.
The EPIC (Evaluating the Use of the FiberNet Embolic Protection Device In Carotid Artery Stenting) study is a US IDE study headed by Dr J Michael Bacharach, North Central Heart Institute, Sioux Falls, SD.
The US multi-center, non-randomised, open label, uncontrolled, prospective, feasibility study is designed to demonstrate the performance and safety of the FiberNet Embolic Protection System (EPS) as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients.
The FiberNet EPS is indicated to capture and remove embolic material produced while performing interventional procedures in vessels. Delivery of the FiberNet system is very similar to advancing a standard 0.014″ steerable guidewire. This allows physicians to steer the device into vessels which are difficult to access or significantly stenosed. Once in place and deployed, it is a highly effective filter. The filter component of the system is composed of a three-dimensional mesh of polyethylene terephthalate (PET) fibres.
The primary outcomes of the study are the rate of all death, stroke, and myocardial infarction within 30 days of the procedure. The secondary outcomes are all death and stroke rates; non-stroke neurological event rates; technical success rates; procedural success rates; and access site complication rates. The study hopes to enrol a total of 30 patients in the US.
The inclusion criteria include: one or more of the high surgical risk criteria, candidates for percutaneous stenting with target lesion located within common or internal carotid artery and symptomatic with atherosclerotic stenosis > 50% or asymptomatic with atherosclerotic stenosis > 70% of the carotid artery as defined by the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.
The exclusion criteria include: allergy to heparin, myocardial infarction or stroke within the last 14 days, TIA within the past 48 hours, angioplasty or PTCA/PTA procedure within the past 48 hours, cardiac surgery within the past 60 days, total occlusion, intracranial stenosis that exceeds the severity of an extracranial stenosis and peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion.
Participating centers include: Hoag Hospital, Newport Beach, CA; Ochsner Clinic, New Orleans, LA; Massachusetts General Hospital, Boston, MA; North Central Heart Insititute, Sioux Falls, SD; St. John’s Hospital, Springfield, IL; Riverside Methodist Hospital, Columbus, OH; and Washington Adventist Hospital, Takoma Park, MD. The first three US patients have been treated with the FiberNet EPS at Riverside Methodist Hospital in Ohio. All recovered from their procedure without incident and have been discharged from the hospital.
“The design of the FiberNet device is significantly different than any other embolic protection system in clinical practice today,” said Dr Ansel of Riverside Methodist Hospital. “It truly appears to be the next-generation of advanced distal protection devices. We have been impressed with its agility and flexibility, and have been amazed at the amount of debris that has been trapped and removed.”
The European study, which includes similar inclusion and exclusion criteria to its US counterpart, plans to enrol 50 patients at five centers. The Principal Investigator is Professor Joachia Schofer, Center for Cardiology, Angiology & Vascular Intervention, Hamburg, Germany.
There are currently three types of embolic protection available: distal filter devices, distal occlusion devices and proximal occlusion devices. The FiberNet distal protection device incorporates the advantages of both occlusion and distal filter protection devices in allowing continuous blood flow throughout the procedure while capturing particles as small as 40 microns. In addition, the FiberNet has a low crossing profile and excellent trackability within the vasculature. The FiberNet has apposition to the vessel wall as it conforms to all vessels. According to the company, all of these features could lead to possible advantages of the FiberNet device and meet the unique needs that other commercially available embolic protection devices do not.
“Bench tests have demonstrated that FiberNet catches a significantly larger percentage of particles than other distal embolic protection filters,” said Jason Galdonik, Director of Research and Development for Lumen Biomedical, “including particles less than half the diameter of those collected by the others on the market”.
The FiberNet device is an investigational medical device and is limited to investigational use only.