CE Mark authorization was received in January 2009 for the FlexStent® Femoropopliteal Self Expanding (SE) Stent Sytem. The FlexStent® Biliary Self Expanding Stent System also received CE Mark authorization in January 2009 and 510(k) clearance in September 2009. The FSS platform offers a nearly fully-connected, very strong yet flexible stent, engineered to solve the problems of first and second generation flexible stents.
Peripheral artery disease (PAD) most commonly results from an accumulation of plaque in the femoropopliteal or the superficial femoral and popliteal (SFA/POP) arteries in the pelvis and leg. Of nearly 30 million people in Europe and North America who have PAD, well over 10 million are symptomatic. In these patients, there is an 80-90% chance that the atherosclerosis occurs in the SFA/POP arteries. Left untreated, PAD increases the risk of heart attack, stroke, amputation and death. While there are many therapies available and under investigation, peripheral artery stenting with angioplasty is the most desirable option.
Our stent is a true third generation SFA/Popliteal stent. This nearly fully connected construction offers excellent radial strength, flexibility, and durability - this design leaves nothing on the table. The 6 French delivery system offers ease-of-use, accuracy and delivers a well apposed, uniform stent. The reconstrainable SDS - offering a game changing technology - is currently under development. FSS's OUS clinical trials are underway. Conditional IDE Approval for its US clinical trials was received in September 2009. CE Mark authorization was received in January 2009. The reconstrainable SDS is currently under development.
Our SFA/Pop FlexStent® product family includes:
Stent Diameter (mm)
Stent Lengths (mm)
SDS Usable Length (cm)
5
30, 40, 60, 80, 100, 120, 150, 200*
80
6
30, 40, 60, 80, 100, 120, 150, 200*
80
7
30, 40, 60, 80, 100, 120, 150, 200*
80
8
30, 40, 60, 80, 100, 120, 150, 200*
80
5
30, 40, 60, 80, 100, 120, 150, 200*
120
6
30, 40, 60, 80, 100, 120, 150, 200*
120
7
30, 40, 60, 80, 100, 120, 150, 200*
120
8
30, 40, 60, 80, 100, 120, 150, 200*
120
This product family is limited by U.S. Federal Law to Investigational Use only. Not approved for sale in the U.S.A.
*CE Mark not applicable and device not approved for Investigational Use in the U.S.A. in this length.
Prevention and treatment of stroke is a major socioeconomic problem. Atherosclerosis in the internal carotid artery (ICA) is the most relevant pathology, and the risk of stroke rises with increasing degrees of carotid stenosis. The American Heart Association estimates that 700,000 Americans will suffer a stroke this year, and approximately 30% of strokes are caused by embolic events originating from diseased carotid arteries. The market potential could be $1 billion to $2 billion upon completion of a successful large trial, two of which are already underway.
The FSS Flexible Stent platform offers a unique solution for delivery to and stenting the carotid arteries. The integration of the helical coil band and helical strut configuration enables a small cell configuration across the length of the stent without compromising the small profile and excellent flexibility required for delivery, or the excellent radial strength. FSS anticipates a first-in-class carotid stent, and will pursue this development through CE Mark authorization.
Wide neck aneurysms are often untreatable surgically or by endovascular means with clipping and coiling.
Clipping involves surgically placing an implantable clip over the neck of the aneurysm, thereby isolating the aneurysm from the circulation. This technique involves precise placement of the clip and requires access to the vessel from the outside to completely capture the neck of the aneurysm. However, some wide neck aneurysms in vessels deep within the brain are not amenable to being treated by open brain surgery.
Coiling involves endovascular placement of embolization coils into the aneurysm sac in order to exclude the aneurysm from the circulation. The advantage is that the coils can be placed from within the vessel. Limitations to coiling wide neck aneurysms include (1) aneurysm neck instability that could lead to coil protrusion and/or embolization and (2) achieving and maintaining sufficiently dense coil packing of the aneurysm to permanently exclude blood flow. If left untreated or inadequately treated, the wide neck aneurysms are at risk of rupture, resulting in a high risk of patient morbidity and mortality.
Peripheral artery disease (PAD) extends below-the-knee into the tibial arteries. Blockage of these arteries increases the risk of amputation, especially where an unhealed ulceration is present. Opening of these arteries is critical for limb salvage.
FSS currently is developing a next generation self expanding stent for use below-the-knee. The stent will be strong, radiopaque, and conformable. The stent delivery system, with its 3 French profile, will provide the interventionist with a low profile, easy-to-use and accurate stenting solution.
Stents under development include 3-mm and 4-mm diameters, and 20, 30, 40, 60, 80, 100 and 120 mm lengths. FSS anticipates CE Mark authorization in late 2009 / early 2010.
Currently not approved for sale in the U.S.
The principal objective in stenting malignant strictures is to provide palliation of jaundice. Jaundice is a yellowing of the skin, conjunctiva and mucous membranes caused by increased levels of bilirubin. Self-expanding metal stents for effective palliation of malignant biliary strictures have been around for many years. However, most of these stents do not differentiate from each other.
FSS offers a unique solution for the interventional radiologist. Our self expanding stent provides exceptional scaffolding with its nearly fully connected construction. Our standard delivery system offers ease-of-use and accurate deployment. CE Mark authorization was received in January 2009. 510(k) clearance was received in September 2009. Our reconstrainable system will further distinguish our stenting system offering the interventional radiologist a complete stenting solution.
Our biliary FlexStent® product family includes:
Stent Diameter (mm)
Stent Lengths (mm)
SDS Usable Length (cm)
5
30, 40, 60, 80*, 100*, 120*
80
6
30, 40, 60, 80, 100, 120*
80
7
30, 40, 60, 80, 100, 120
80
8
30, 40, 60, 80, 100, 120
80
5
30, 40, 60, 80*, 100*, 120*
120
6
30, 40, 60, 80, 100, 120*
120
7
30, 40, 60, 80, 100, 120
120
8
30, 40, 60, 80, 100, 120
120
*Sizes currently not approved for sale in the U.S.
