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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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The NeVa PV Thrombectomy Device is indicated for:

• The non-surgical removal of thrombus burden from coronary blood vessels,
• Use with adjunctive aspiration and with the injection or infusion of contrast media and other fluids.

The NeVa PV Thrombectomy Device ("NeVa") is a mechanical thrombectomy device that is temporarily inserted into the coronary vasculature under angiographic visualization in order to remove emboli and thrombus to restore blood flow to occluded vessels. The overall design of NeVa is similar to other commercially mechanical thrombectomy devices that use a self-expanding nitinol basket attached to a core pusher wire. To optimize emboli and thrombus removal, NeVa employs a capture cell design within the nitinol basket structure that incorporates a proprietary drop zone pattern. This proprietary drop zone design maximizes clot retrieval efficiency without changing the mechanism of action used by mechanical thrombectomy devices. As with other mechanical thrombectomy devices, NeVa is intended to be delivered through a compatible commercially available microcatheter to the target vessel. NeVa is intended to be retrieved into a guiding catheter with adjunctive aspiration to reduce potential emboli. NeVa is provided sterile and intended for single-use only. To accommodate different vessel diameters and clot sizes, NeVa is provided in multiple expandable tip sizes and configurations.

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The Cannula is indicated for:

• the non-surgical removal of thrombi or emboli from the vasculature
• aspiration and injection of contrast media and other fluids from and into the vasculature

The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.

The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.

The Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of the AlphaVac Cannula/Obturator and other endovascular devices while minimizing blood loss associated with such insertions.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a single use-over-wire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA Systems are comprised of six main components packaged together:

• a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip
• AlphaVac Sheath
• AlphaVac Obturator
• AlphaVac Handle
• Collection Bags
• AlphaVac Tubing

The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag are connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature. The device is provided in ~85° angled configuration.

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The ClotTriever Thrombectomy System is indicated for:

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

The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).

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The Vesalio Peripheral Catheter is intended for use in the peripheral arterial vasculature for:

• the removal of fresh, soft emboli and thrombi
• infusion of diagnostic agents, such as contrast media

The Vesalio Peripheral System consists of 1) Peripheral Catheter, 2) Peel away Introducer Sheath and 3) an Aspiration Tubing Set.

The Peripheral Catheter is a single-lumen, coil-reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the peripheral arterial vasculature when connected to a compatible aspiration pump and the Aspiration Tubing Set.

The catheter is a hollow cylindrical tube constructed using a combination of medical-grade polymers with metal reinforcement, a lubricous inner liner made from PTFE and the outer jacket consisting of thermoplastics made of polyurethane, polyether block amide, and nylon 12. The distal end of the catheter has a hydrophilic coating aimed to reduce friction and aid tracking through the vasculature. The catheter employs radiopaque characteristics for angiographic visualization.

On the proximal end, the catheter incorporates a flexible strain relief, which provides kink resistance, and a translucent, polycarbonate female luer hub to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter.

A peel-away introducer sheath is provided in the package to facilitate the insertion of the Peripheral Catheter's distal tip into an appropriate vascular sheath.

The Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to an RHV or the female luer hub of the catheter. The other end of the tubing consists of a hose fitting to enable connection with a vacuum pump. A flow switch is connected in line to provide vacuum control. The Peripheral System is provided sterile, non-pyrogenic, and is intended for single use only.

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