Device Description - Merit Medical Torpedo Instrucciones De Uso

CAUTION: Federal (U.S.A.) law restricts this device to use by or on the order of a
licensed physician.

DEVICE DESCRIPTION

The Torpedo™ consists of biocompatible, hydrophilic and resorbable dry gelatin foam that is
compressed into a cylindrical shape and preloaded into a cartridge with a standard female
and male luer fittings.
Based on an animal model, the gelatin foam Torpedo showed signs of resorption at week 4.
MAGNETIC RESONANCE IMAGING
The Torpedo is made of porcine gelatin and has no ferrous composition.
SPECIFICATIONS
The Torpedo is available in two sizes (2.5 mm and 5.0 mm) and two lengths (10 mm and 20 mm)
with the specifications for each size listed below:
Compressed
Part
/ Dehydrated
Number
Torpedo Diameter
TOR2510 0.9 mm
TOR2520 0.9 mm
TOR5010 1.7 mm
TOR5020 1.7 mm
The Torpedo is designed for use with a catheter with an inner diameter large enough to allow
delivery of the Torpedo through the catheter to the target vasculature via syringe injection.
INDICATION
The Torpedo is indicated for use in the embolisation of:
• Hypervascular tumors,
• Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral
vasculature.
Torpedo Gelatin Foam size 2.5 mm occludes vessels up to 2.5 mm and Torpedo Gelatin Foam
size 5 mm occludes vessels up to 5 mm.
CONTRAINDICATIONS
• Patients with known allergy to gelatin
• Patients intolerant to occlusion procedures
• Vascular anatomy or blood flow that precludes catheter placement or embolic agent
injection
• Presence of vasospasm
I N S T R U C T I O N S F O R U S E
Uncompressed /
Hydrated Torpedo
Diameter
2.5 mm
2.5 mm
5.0 mm
5.0 mm
Torpedo Recommended
Length Injection Syringe
10 mm 1 ml
20 mm 1 ml
10 mm 3 ml
20 mm 3 ml
English
Minimum Color
Catheter ID Code
0.027"
Yellow
(0.69 mm)
0.027"
Yellow
(0.69 mm)
0.040"
Purple
(1.02 mm)
0.040"
Purple
(1.02 mm)