Indicated for femoral and infrapopliteal arteries. Being a relatively mobile artery, the SFA requires a stent that conforms to the natural vessel movement and provides sufficient support in complex, long lesions that are often difficult to cross. Pulsar-18 is a stent designed for SFA with high multi-directional flexibility on a low-profile delivery system.
- One-handed stent release for accurate stent deployment
- Low profile 4 F delivery system with stents of up to 7 x 200 mm
- S-articulating connecting bars and peak-to-valley design for multi-directional flexibility
- Segmented stent design with thin struts for lower restenosis rates
One-Handed Stent Release
Ergonomically designed for a comfortable and stable handling, enhancing ability to immobilize complete system during stent deployment.
- Safety Tab: Avoids accidential stent deployment
- Trigger: For controlled stent delivery
- Easy release: Relieves friction of introducer valve on the retractable shaft during stent deployment for a smoother action.
Stent Designed for SFA
- Peak-to-valley design and S-articulating connecting bars provide multi-directional flexibility and avoid fish-scaling in mobile vessel architecture.
- A segmented design with thin struts provides low chronic outward force (COF)1 sufficient to maintain vessel scaffolding even in calcified lesions (4EVER study)2. High COF has been shown to result in higher rates of neointimal hyperplasia.3
- Stent lengths up to 200 mm cover long lesions with a single stent.
Low Profile Delivery System
4 F distal shaft profile for easier lesion crossing.
3.6 F proximal shaft for contrast injection with device positioned inside introducer and across lesion.
Low Chronic Outward Force
Low Chronic Outward Force (COF)1 sufficient to maintain vessel scaffolding even in calcified lesions (4EVER study2). COF of Pulsar stents increases less than many competitor stents when oversized, thus potenitally reducing inflammatory response and restenosis3.
- Primary endpoint: Primary Patency (PP) at 12 months
- Number of patients (n): 120
- Single-center, retrospective registry
- Number of patients (n): 31
- Endpoints: Primary patency (PP), technical success, procedural complications, freedom from Target Lesion Revascularization (FTLR), Stratified for critical limb ischemia (CLI) vs. intermittent claudication (IC)
- Prospective, multi-center, investigator-initiated registry to evaluate the implantation outcome of the Pulsar-18 stent followed by Passeo-18 Lux DCB in the femoropopliteal arteries.
- Number of patients (n): 65 (12-month data available on n 51)
- Primary endpoint: PP at 12 and 24 months, defined as a binary duplex ultrasound ratio PSVR < 2.5 at the stented target lesion with no clinically-driven reintervention within the stented segment.
- Multi-center, prospective all-comers registry
- Number of patients (n): 148
- Endpoints: PP at 6 and 12 months and FTLR
- Single-center, prospective registry
- Number of patients (n): 22
- Endpoints: primary patency (PP)2 2 at 12 months and freedom from Target Lesion Revascularization (FTLR)
TASC D II
- Prospective, multi-center, investigator-initiated registry to evaluate the outcome of the implantation of the Pulsar-18 stent in lesions >15 cm in the femoropopliteal arteries.
- Number of patients (n): 36
- Primary endpoint: PP at 6 and 12 months, defined as a binary restenosis on duplex ultrasound (PSVR < 2.5) at the stented target lesion with no clinically-driven TLR (cd-TLR) within the stented segment
|Recommended guide wire||0.018"|
|Strut thickness||140 μm|
|Strut width||85 μm|
|Stent coating||proBIO (amorphous silicon carbide)|
|Stent markers||6 gold markers each end|
|Sizes||ø 4.0 - 7.0 mm; L: 204 - 200 mm|
|Proximal shaft||3.6 F, hydrophobic coating|
|Usable length||90 and 135 cm|
1 BIOTRONIK data on file (IIB report (P) 71/2011-1).
2 4EVER study. Bosiers. M. 24m results presented CIRSE 2013; Deloose K. 24m results presented LINC 2014.
3 -Ballyk PD. Intramural stress increases exponentially with stent diameter: a stress threshold for neointimal hyperplasia. J Vasc Interv Radiol. 2006 Jul;17(7):1139-45. -Freeman JW, Snowhill PB, Nosher JL. A link between stent radial forces and vascular wall remodeling: the discovery of an optimal stent radial force for minimal vessel restenosis. Connect Tissue Res. 2010 Aug;51(4):314-26. -Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized Nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol. 2009 Jul;32(4):720-6".
4 8 weeks pre-order only