INDICATED FOR FEMORAL AND INFRAPOPLITEAL ARTERIES
Being a relatively mobile artery, the SFA (superficial femoral artery) requires a stent that conforms to natural vessel movement and sufficiently supports 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 4F delivery system with stents of up to 7 x 170 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 170 mm cover long lesions with a single stent.
Low Profile Delivery System
- 4F distal shaft profile for easier lesion crossing. 3.6F proximal shaft for contrast injection with device positioned inside introducer and across lesion.
Low Chronic Outward Force
- Low Chronic Outward Force (COF)1 is sufficient to maintain vessel scaffolding even in calcified lesions (4EVER study2). As shown in the graphic, COF of Pulsar stents increases less than many competitor stents when oversized, thus potenitally reducing inflammatory response and restenosis3.
- The objective of this clinical investigation is to evaluate the short- and long-term (up to 24 months) treatment outcome by means of dilation with the Passeo-18 Lux drug-releasing balloon and by Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions. ▪ Estimated enrollment: 120
- A prospective, multicenter, investigator-initiated registry to evaluate the implantation outcome of the Pulsar-18 stent followed by Passeo-18 Lux Drug-Coated Balloon in the femoropopliteal arteries. ▪ Number of patients (n): 65 (12-month data available for: (n) 51).
|Recommended guide wire
||proBIO (amorphous silicon carbide)
||6 gold markers each end
||ø 4.0 - 7.0 mm; L: 204 - 170 mm
||3.6F, hydrophobic coating
||90 and 135 cm
1BIOTRONIK data on file (IIB report (P) 71/2011-1).
24EVER 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".