Peripheral and biliary stents

Visi-Pro™ balloon-expandable peripheral stent system

<p>Ensure precise stent placement with the Visi-Pro balloon-expandable peripheral stent system.</p>

Indications, Safety, and WarningsNote: Safety information provided is for the United States. Refer to your region’s instructions for use for specific details.This therapy is not for everyone. Please consult your physician. A prescription is required. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.IndicationsThe Visi-Pro™ balloon-expandable peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 mm to 10 mm.The Visi-Pro™ balloon-expandable peripheral stent system is intended as a palliative treatment of malignant neoplasms in the biliary tree.ContraindicationsUse of the Visi-Pro™ balloon-expandable peripheral stent system is contraindicated in patients with known hypersensitivity to stainless steel or its components; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site; perforation at the angioplasty site; aneurysm of the artery to be treated.Potential adverse eventsPotential adverse events which may be associated with the use of a stent in the iliac arteries include, but are not limited to: abrupt or sub-acute closure, allergic reaction to 316 L stainless steel, allergic reaction to device materials or procedure medications, amputation, aneurysm, angina, arrhythmia, arterio-venous fistula, artery injury (e.g., dissection, perforation, or rupture), bleeding requiring transfusion, contrast medium reaction/renal failure, death, device breakage, embolism, failure to deploy stent, fever, gastrointestinal bleeding due to anticoagulation, hematoma, hypertension/hypotension, infection, inflammation, intraluminal thrombus, myocardial infarction, pain, partial stent deployment, pseudoaneurysm, renal insufficiency, restenosis, sepsis, shock, stent collapse or fracture, stent migration, stent misplacement, stroke, surgical or endovascular intervention, thrombosis/occlusion of the stent, transient increase in glomerular filtration rate, transient ischemic attack, venous thromboembolism, vessel spasm, worsening claudication or rest pain.See the instructions for use provided with the product for a complete list of warnings, precautions, adverse events, and device information.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.FTSOP113326-37 Rev. 1AUC201712593aEN

Indications

Peripheral

The Visi-Pro™ balloon-expandable peripheral stent is indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk of stenosis following PTA in the following arteries:

common and external iliac
renal

Stenting is intended to improve and maintain artery luminal diameter.

Biliary

The Visi-Pro™ balloon-expandable peripheral stent is indicated for use as a palliative treatment of malignant neoplasms in the biliary tree.

All indications related to the Visi-Pro™ Balloon-expandable Peripheral and Biliary Stent are not approved globally, please refer to the complete Instructions for Use manual for the indication for Use approved in your geography.

Product details

Premium visibility

Distinct 0.035" balloon-expandable stent with radiopaque markers ensuring visibility during and after stent placement

Solid radial strength and flexibility

Patented design balancing strength and flexibility

Precise placement

For minimal dilation of healthy tissue due to balloon to stent placement
Providing accurate catheter marker alignment to balloon taper
Progressive stent design delivering minimal shortening

Ordering information

80 cm	135 cm	Balloon diameter (mm)	Length (mm)	Balloon length (mm)	Recommended introducer sheath (Fr)	Guidewire (in)
PXP35-06-12-080	—	6	12	15	6 (0.085" ID)	0.035
PXP35-06-17-080	PXP35-06-17-135	6	17	20	6 (0.085" ID)	0.035
PXP35-06-27-080	PXP35-06-27-135	6	27	30	6 (0.085" ID)	0.035
PXP35-06-37-080	PXP35-06-37-135	6	37	40	6 (0.085" ID)	0.035
PXP35-06-57-080	PXP35-06-57-135	6	57	60	6 (0.085" ID)	0.035
PXP35-07-12-080	—	7	12	15	6 (0.085" ID)	0.035
PXP35-07-17-080	PXP35-07-17-135	7	17	20	6 (0.085" ID)	0.035
PXP35-07-27-080	PXP35-07-27-135	7	27	30	6 (0.085" ID)	0.035
PXP35-07-37-080	PXP35-07-37-135	7	37	40	6 (0.085" ID)	0.035
PXP35-07-57-080	PXP35-07-57-135	7	57	60	6 (0.085" ID)	0.035
PXP35-08-17-080	PXP35-08-17-135	8	17	20	6 (0.085" ID)	0.035
PXP35-08-27-080	PXP35-08-27-135	8	27	30	6 (0.085" ID)	0.035
PXP35-08-37-080	PXP35-08-37-135	8	37	40	6 (0.085" ID)	0.035
PXP35-08-57-080	PXP35-08-57-135	8	57	60	6 (0.085" ID)	0.035
PXP35-09-17-080	PXP35-09-17-135	9	17	20	7	0.035
PXP35-09-27-080	PXP35-09-27-135	9	27	30	7	0.035
PXP35-09-37-080	PXP35-09-37-135	9	37	40	7	0.035
PXP35-09-57-080	PXP35-09-57-135	9	57	60	7	0.035
PXP35-10-17-080	PXP35-10-17-135	10	17	20	7	0.035
PXP35-10-27-080	PXP35-10-27-135	10	27	30	7	0.035
PXP35-10-37-080	PXP35-10-37-135	10	37	40	7	0.035
PXP35-10-57-080	PXP35-10-57-135	10	57	60	7	0.035

Compliance chart

Visi-Pro Diameter (mm)	Inflation Pressure (atm)
Visi-Pro Diameter (mm)	8	9	10	11	12
5.0	5.00	5.06	5.16	5.22	5.28
6.0	6.00	6.11	6.22	6.31	6.39
7.0			7.00	7.09	7.17
8.0			8.00	8.15	8.26
9.0			9.00	9.15	9.28
10.0			10.00	10.11	10.21

	Diameter at nominal pressure
	Diameter at RBP