Edwards Lifesciences T38F30 Carotid Shunt

Condition: New
Part #: T38F30

$8,000.00

SKU: T38F30 Categories: ,
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Description

The Edwards Lifesciences T38F30 is a specialized, sterile, single-use silicone shunt engineered for Carotid Endarterectomy (CEA). As a critical component of the Vascushunt II product line, the T38F30 is designed to maintain continuous cerebral perfusion while the carotid artery is clamped, significantly reducing the risk of intraoperative stroke and neurological deficit. With an 8F diameter and a 30 cm outlying length, this device provides surgeons with the necessary reach and flow capacity for complex distal vessel access.

Core Technology

The T38F30 leverages medical-grade silicone construction, chosen for its superior biocompatibility and mechanical properties. Unlike stiffer materials, this high-flexibility silicone is inherently kink-resistant, ensuring the lumen remains patent even when the shunt is looped to clear the surgical field. A defining feature of this model is the integrated Safety Balloon technology, which acts as a pressure-relief mechanism to protect the fragile internal carotid artery from trauma caused by accidental overinflation.

Mechanism of Action

During a CEA procedure, the T38F30 serves as a temporary bypass. Once the common carotid and internal carotid arteries are identified, the shunt is inserted and secured. Oxygenated blood is diverted from the common carotid artery through the 30 cm silicone tubing directly into the distal internal carotid artery. The integrated stopcocks allow the surgical team to bleed air from the system or monitor pressure, ensuring a bubble-free, high-flow environment that sustains the brain’s metabolic needs while the surgeon removes plaque from the arterial wall.

Applications and Clinical Uses

The Vascushunt II T38F30 is indicated for use in adult patients undergoing vascular reconstruction of the carotid arteries. Its primary applications include:

  • Carotid Endarterectomy (CEA): Standard of care for preventing cerebral ischemia during arterial clamping.

  • Distal Vessel Access: Utilizing the 30 cm length to navigate difficult anatomy or high-sitting bifurcations.

  • Vascular Trauma: Temporary shunting during emergency repair of the carotid sheath.

Key Advantages

  • Atraumatic Design: The soft silicone and safety balloon system minimize the risk of intimal dissection or vessel wall perforation.

  • Unobstructed Surgical Field: The 30 cm “outlying” length allows the bulk of the shunt to stay outside the primary incision area, improving visibility for the surgeon.

  • Precise Flow Management: Built-in stopcocks provide immediate access for flushing or sampling without interrupting the primary bypass flow.

  • Reliable Performance: Full compatibility with the Edwards Lifesciences Vascushunt II system ensures standardized surgical protocols and predictable outcomes.

Surgical Integration Process

  1. Preparation: The T38F30 is flushed with heparinized saline via the integrated stopcocks to ensure all air is removed.

  2. Insertion: Following the arteriotomy, the distal end is placed into the internal carotid artery, followed by the proximal end into the common carotid.

  3. Fixation: The safety balloons are inflated to secure the shunt in place, ensuring an internal seal that avoids the need for aggressive external clamping.

  4. Perfusion Monitoring: Throughout the plaque excision, the stopcocks allow for continuous monitoring of shunt patency.

  5. Removal: Once the primary repair is near completion, the balloons are deflated and the shunt is withdrawn just prior to the final vessel closure.

Technical Specifications

Feature Specification
Model Number T38F30
Product Line Vascushunt II
Diameter 8 French (8F)
Total Length 30 cm (Outlying)
Material Kink-resistant, Medical-grade Silicone
Safety Features Integrated Safety Balloon (Pressure Protection)
Flow Control Dual Integrated Stopcocks
Sterility Gamma Sterilized, Single-Use Only

Frequently Asked Questions

What is the primary function of the Safety Balloon on the T38F30?

The Safety Balloon is designed to protect the internal carotid artery from barotrauma. In the event of overinflation during the fixation process, the safety mechanism diverts excess pressure to prevent the balloon from exerting dangerous force against the delicate vessel walls, reducing the risk of arterial rupture or dissection.

Why is kink-resistant silicone important for carotid shunts?

During a CEA, the surgical site is often crowded with retractors and instruments. Kink-resistant silicone ensures that even if the shunt is bent at an acute angle to stay out of the surgeon’s way, the internal diameter remains open, maintaining the constant blood flow necessary for cerebral perfusion.

Is the Edwards T38F30 compatible with other vascular systems?

The T38F30 is specifically engineered for compatibility within the Edwards Lifesciences Vascushunt II system. This ensures that the inflation lumens, stopcocks, and material transitions work harmoniously. Using it outside of its intended system may compromise the safety features or the reliability of the fluid seal.

How does the 30 cm length benefit the surgical workflow?

The 30 cm “outlying” length provides a longer bridge between the proximal and distal insertion points. This is particularly advantageous for surgeons who prefer to loop the shunt away from the arteriotomy site, providing a cleaner, less obstructed workspace for the meticulous removal of atherosclerotic plaque.

What are the sterilization requirements for this device?

The T38F30 is provided sterile and is intended for single-use only. It should not be re-sterilized or reused, as medical-grade silicone and integrated balloon components can degrade under heat or chemical exposure, potentially failing during subsequent procedures and posing a significant risk to the patient.

Can this shunt be used for pediatric patients?

While carotid shunts are designed for vascular bypass, the 8F diameter and 30 cm length of the T38F30 are typically sized for adult anatomy. Pediatric cases usually require smaller French sizes. Clinicians should refer to the specific IFU (Instructions for Use) to confirm patient population compatibility.

Listing Terms & Conditions

We ship worldwide, please inquire the shipping rate to your country before placing an order.

We carry all products of this brand in the listing, please let me know if you have any other inquires which is not listed in our store.

All purchases over $1,000 must be paid by wire transfer. We cannot accept international credit card payments for orders over $1,000.

Due to worldwide shipping delays, it is possible that items listed could be on backorder. If the item is unavailable for an extended period, we sincerely apologize for the delay. In this case, we will refund you as soon as we are notified of the backorder and contact you with the confirmation of refund.