PTS-0607-7F135: Surmodics Pounce 7F Thrombectomy Device 135cm

Expired » Surmodics » Thrombectomy

Surmodics Pounce Thrombectomy System 

The Pounce thrombectory system is intended for the nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 to 6 mm in diameter. The Pounce LP, a new addition to the Pounce platform, is indicated for use in vessels ranging from 2 to 4 mm in diameter, sizes typical of vessels found below the knee.

Product Code: PTS-0607-7F135

• Sheath Compatibility: 7F
• Guidewire Compatibility: 0.035" (0.889mm)
• Working Length: 135cm
• Basket Diameter: 6mm
• Funnel Diameter: 7mm
• Delivery Catheter Working Length: 135cm
• Delivery Catheter Proximal Diameter: 0.074" (1.88mm)
• Delivery Catheter Distal Diameter: 0.064" (1.62mm)
• Basket Wire Working Length: 300cm
• Wire Outer Diameter: 0.026" (0.66mm)
• Basket Outer Diameter: 6mm
• Basket Length: 4.5cm
• Tip Length: 3.4cm
• Funnel Catheter Working Length: 120cm
• Funnel Length: 6.5cm
• Funnel Outer Diameter: 7mm

The Pounce mechanical thrombectomy device is designed to promptly remove organized thrombus or embolus without the need for capital equipment, thrombolytics, or aspiration.

The system is composed of three components: a 5-F delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7-F guide sheath through which the clot is removed from the body

Sterilization

• Device Packaged as Sterile: Yes
• Requires Sterilization Prior to Use: No 
• Single-Use
• Disposable

Additional Details

• Company Name: Surmodics, Inc.
• FDA Product Code: QEW
• FDA Product Code Name: Peripheral Mechanical Thrombectomy With Aspiration
• GMDN Term Code: 58173
• GMDN Term Name: Thrombectomy suction catheter
• GMDN Term Definition: A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Surmodics is a leading provider of medical devices and biomaterials, specializing in drug delivery systems and vascular interventions. Their product portfolio includes catheters, stents, and vascular access products, with a strong emphasis on innovative solutions for drug-coated devices and biocompatible coatings.