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The FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:

• FLOWRUNNER Aspiration Catheter
• FLOWRUNNER Aspiration Sheath
• Vacuum Fitting
• High Flow Stopcock Connector
• Y-Connector with Hemostatic Valve
• Hand Actuator Clip

The FLOWRUNNER Aspiration System family is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. The extension of the device family includes smaller-diameter sizes of the FLOWRUNNER Aspiration System. The system is a single-use catheter-based device with the capability to infuse fluids.

FLOWRUNNER SP Aspiration System is over the wire system.

FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The FLOWRUNNER Aspiration System is introduced to the site of the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

The FLOWRUNNER Aspiration System comes in 7F, SP 7F, 12F, and 14F compatible diameters and 60cm, 80cm, 100cm, 120 and 130cm lengths.

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The Versus™ Catheter is indicated for:

The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.

The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

The Versus™ Pulmonary Artery Catheter is a dual-tip, infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer.

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INDIGO Aspiration Catheters and Separators
As part of the Indigo INDIGO Aspiration System, the Indigo INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

INDIGO Aspiration Tubing
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of several devices:

• INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Aspiration Pump Canister
• INDIGO Aspiration Tubing
• INDIGO Separator

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion.

The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

Lightning Aspiration Tubing
The Lightning Aspiration Tubing is a component to the currently available INDIGO Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration. Intended users for this device are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is provided sterile, non-pyrogenic, and intended for single use only.

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The CLEANER™ Vac Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The CLEANER™ Vac Thrombectomy System is not intended for use in the pulmonary vasculature for treating pulmonary embolism.

The CLEANER™ Vac Aspiration Canister is indicated as a vacuum source for the CLEANER™ Vac Thrombectomy System.

The CLEANER™ Vac Thrombectomy System is a single use device intended for the removal of fresh, soft emboli and thrombi and for the infusion of physician selected fluids through the side-port of the aspiration catheter.

The disposable system consists of:

• The CLEANER™ Vac Aspiration Catheter with Handpiece, and
• The CLEANER™ Vac Aspiration Canister (external vacuum reservoir with pump).

The Aspiration Catheter with handpiece includes a Dilator and may be placed over-the-wire to navigate the device to the target site. Once in the target site, to complete the system, the Aspiration Canister is connected to the handpiece. The dilator is removed, and the device is activated by the user to aspirate soft emboli and thrombi. The clot is aspirated from the distal portion of the device through the handpiece and then collected in the aspiration canister reservoir.

Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.

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The Aventus Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Aventus Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from pulmonary arteries, the peripheral vasculature and/or infusing fluids. The System is comprised of the following major components:

• Aventus Thrombectomy Catheter
• Clot Management System consisting of:
  • Aspiration Syringe
  • Clot Canister

The System is compatible with a standard 24-French (24F) introducer sheath, Navigation Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.

The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics.

The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness, and includes a hydrophilic coating applied to the outside of the catheter shaft.

The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

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The Sangria™ Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous system ≥ 7mm in diameter.

The Sangria™ Thrombectomy System (Sangria™ System) is a sterile, single-use, percutaneous, 14 Fr catheter-based system (single-piece construction) designed for the removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. The 14Fr, over-the-wire Catheter features a battery-operated handle with a slider that deflects the Catheter to target thrombus. A power switch on the handle activates rotation of the tip. Once activated, the tip rotates to break down the thrombus, which is then cleared proximally through the Catheter lumen and aspiration port into an external canister via vacuum aspiration. The Catheter is offered in a Straight Sheath configuration.

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The Hēlo Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature.
• The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels.

The Hēlo Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism.

The Hēlo Audible Flow Indicator is intended for use exclusively with the Hēlo Thrombectomy System and provides audible feedback of rapid flow through the device during a thrombectomy procedure.

The Hēlo Thrombectomy System (Hēlo System) is a minimally invasive aspiration system designed for the removal of thromboembolic material from the pulmonary arteries. It can be initially introduced with a 16 Fr introducer sheath and expands to 8 mm at the distal portion once inside the vasculature. The Hēlo System allows for engagement with the targeted clot, aspiration of the targeted clot, and transportation of aspirated clot out of the body. The Hēlo System is supplied sterile using Ethylene Oxide gas and is intended for single-use only. The Hēlo System is comprised of the following components:

• Aspiration Catheter: The Aspiration Catheter includes a funnel, an outer sleeve, and an integrated handle with controls. The handle also features a side port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter, and for measurement of intravascular pressure using a standard pressure line setup, if needed. A second side port is used to purge air from the outer sleeve prior to use. The Aspiration Catheter is compatible with a 0.035" or 0.038" guidewire. It connects to a commercially available vacuum pump.

• Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter. It includes a drive unit that connects to the proximal end of the Aspiration Catheter. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter during use.

• Rotating Hemostatic Valve (RHV): The RHV is an accessory that can be attached to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy Borst valve to enable compatibility and sealing on ancillary devices, such as guidewires.

• 9F Dilator: The 9F diameter, Dilator is an accessory that is compatible with 0.035" or 0.038" guidewires and can be used to facilitate navigation through the heart.

• Audible Flow Indicator (AFI): The AFI is an optional accessory that connects between the suction port of the aspiration handle and the suction canister and provides audible feedback to the operator when actuation of the Suction/Agitator Control Button results in full flow through the device. A clot catcher made up of a coarse filter attaches to the suction canister and provides visualization of the clot.

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The Intri26 Introducer Sheath is indicated:

• To provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
• For the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Intri26 Introducer Sheath is an introducer sheath consisting of a short, single-lumen catheter with a hydrophilic coating, proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid fluoroscopic visualization. The Intri26 dilator is compatible with a 0.035" guidewire and has a tapered leading edge, which aids insertion and positioning of the sheath.

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The Akura Thrombectomy Catheter System:
As part of the Akura Thrombectomy System, the Akura Thrombectomy Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Akura Thrombectomy Accessory Kit:
As part of the Akura Thrombectomy System, the Akura Accessory Kit is indicated to connect the Akura Thrombectomy Catheter to the Akura Thrombectomy Console.

The Akura Thrombectomy Console:
The Akura Thrombectomy Console is indicated as a vacuum source for the Akura Thrombectomy System.

The subject Akura Thrombectomy System is designed to remove thrombus from the vasculature. The System is used by interventionalists trained in percutaneous endovascular thrombectomy procedures. The subject Akura Thrombectomy System is comprised of several devices.

• Akura Thrombectomy Catheter System
  • Akura Thrombectomy Catheter
  • Akura Thrombectomy Sheath
  • Akura Thrombectomy Dilator
• Akura Thrombectomy Console
• Akura Accessory Kit
  • Saline Pump
  • Irrigation Tubing
  • Aspiration Canister Assembly

During use, the Akura Thrombectomy Catheter System and Akura Thrombectomy Accessory Kit are connected to the Akura Thrombectomy Console that is placed outside the sterile field. The Akura Thrombectomy System is introduced through percutaneous access using a commercially available 16F vascular introducer sheath and a 0.035 in exchange length guidewire. The Akura Thrombectomy Catheter System is delivered to the target treatment site under fluoroscopic guidance. The Akura Thrombectomy Dilator is removed from the Akura Thrombectomy Sheath. The Akura Thrombectomy Catheter is inserted through the Akura Thrombectomy Sheath, and the Akura Thrombectomy Catheter funnel is deployed. Thrombus is removed by fragmentation using internal saline jets and aspiration. After the procedure, the Akura Thrombectomy Catheter System is removed from the vasculature and disposed of using standard hospital practices. The Akura Thrombectomy Console is cleaned and stored in accordance with the Akura Thrombectomy System User Manual.

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