Indications, Safety, and Warnings
Telescope™ Guide Extension Catheter

Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warning and precautions.

Indications for use

Telescope™ guide extension catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

Contraindications

The guide extension catheter is contraindicated in the following situations:

In vessels less than 2.5 mm in diameter

In vessels in the neurovasculature or the venous system

Warnings

For single-patient and single-procedure use only. Do not resterilize or reuse the device. Resterilization or reuse can compromise device performance and increase the risk of inadequate resterilization and cross-contamination.

Do not advance the guide extension catheter into a vessel without a leading guidewire because vessel damage can occur.

Do not advance the guide extension catheter into a vessel with an effective diameter less than 2.5 mm. Vessel injury, ischemia, and occlusion can occur. If pressure in a vessel dampens after inserting the guide extension catheter, withdraw the guide extension catheter until the pressure returns to normal.

Use the guide extension catheter before the Use-by date specified on the package.

Perform PTCA only at hospitals where emergency coronary artery bypass graft surgery can be performed in the event of a potentially injurious or life-threatening complication.

Do not apply torque to the guide extension catheter during delivery because catheter damage can occur. Torquing the device can result in wire wrap or damage to the device or vessel.

Due to the size and the non-tapered tip of the guide extension catheter, use extreme care to avoid vessel occlusion and damage to the wall of the vessels.

If strong resistance is encountered during manipulation of the devices, do not force passage. Determine the cause of the resistance before proceeding. If the cause cannot be removed, withdraw all the devices simultaneously.

Do not use the guide extension catheter if the packaging has been damaged. A damaged package could result in a breach of sterility or device damage.

Precautions

Inspect the guide extension catheter before use for any bends or kinks. Do not use a damaged catheter. Vessel damage and inability to advance or withdraw the catheter can occur.

Flush the guide extension catheter lumen with sterile, heparinized saline before use.

Use caution when handling the guide extension catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.

When the guide extension catheter is in the body, manipulate the catheter only under fluoroscopy. Do not attempt to move the catheter without observing the resultant tip response, because catheter damage or vessel injury can occur.

Do not advance the guide extension catheter more than 15 cm beyond the tip of the guide catheter because the guide extension catheter can become lodged in the guide catheter making it difficult to remove.

Do not withdraw an undeployed stent back into the guide extension catheter when the catheter is in the body, because it can dislodge the stent. Instead, simultaneously pull both the guide extension catheter and undeployed stent back into the guide catheter and remove them together.

Do not inject contrast media solution at high pressure during the procedure.

This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures.

Administer appropriate anticoagulation, antiplatelet, and vasodilator therapy to the patient.

Adverse effects

Potential issues that can be associated with the guide extension catheter include, but are not limited to, the following adverse effects:

Death

Embolism

Slow-flow

Foreign body in patient

Stent dislodgement

Thrombus

Vessel dissection

Vessel perforation

Occlusion (CVA/MI/spasm)

Aneurysm

Avulsion

Reaction

Infection

Blood loss/hemorrhage/hematoma (vascular access complication)

Renal failure (contrast induced nephropathy)

Pulmonary infarct

Tissue necrosis

The occurrence of the above listed complications may lead to the need for a surgical intervention.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for the full product information.

UC201911575a EN

Telescope™ guide extension catheter

For coronary artery disease

Telescope guide extension catheter features our TruFlex™ soft polymer tip and SmoothPass technology to help channel interventional devices.

Download brochure

Purple and green Telescope™ guide extension catheter

Alert Indications, Safety, and Warnings

Overview

Extended reach. Smooth delivery.

In difficult cases, guide extension catheters (GEC) provide extra backup support and improve access to distal lesions.¹

Telescope GEC features bold technology — and our market-leading² catheter expertise.

Product features and design

Superior deliverability³ and pushability⁴

Telescope GEC has superior deliverability³ to assist in difficult cases.

Pushability is a critical component of deliverability.

TruFlex™ soft polymer tip

You want a soft, flexible tip with responsiveness when you need it.

Our extruded TruFlex tip required at least 39% less force to deflect.⁵

Tip design

Diagram showing close-up of Telescope™ TruFlex™ tip with numbered callouts

2 mm TruFlex tip
2 mm distal marker band
5 mm distal segment featuring soft polymer
Main jacket

SmoothPass technology

After positioning a GEC, the ability to deliver stents, balloons, and other interventional devices through the catheter is critical.

Telescope™ guide extension catheter (GEC) entry port

Telescope GEC with SmoothPass technology includes three components that work together to help channel interventional devices:

Close-up of straightened Telescope™ catheter with numbered callouts

Tapered distal pushwire section — transitions from solid, round, proximal pushwire for flexibility⁶
Short 4 cm polymer on-ramp — maintains superior deliverability and channels interventional devices³
Entry port — contributes to smooth device entry and delivery

Telescope GEC in glass aortic arch model

Close-up of Telescope™ entry port with stent passing through on-ramp

Spade-shaped marker band confirms orientation of catheter on fluoroscopy
Entry port
Resolute Onyx™ DES traveling along the on-ramp toward the entry port
On-ramp

Distal 25 cm of catheter

Coil-reinforced design and hydrophilic coating help improve flexibility and deliverability
PTFE liner provides a low-friction inner lumen

Telescope™ guide extension catheter shown in a loop with numbered callouts

Flexible TruFlex soft polymer tip⁵
Rigid polymer in proximal jacket for luminal integrity⁶
Flexible polymer in main jacket for deliverability
Solid, round pushwire featuring superior pushability⁴

Resources

Ordering information

French size (F)	CFN
6 F	TELE6F
7 F	TELE7F

Downloads

pdf Telescope GEC vs Guidezilla II comparison (.pdf)

459KB

See comparison

pdf Telescope GEC vs GuideLiner comparison (.pdf)

427KB

View comparison

pdf Telescope GEC compatibility poster (.pdf)

424KB

Download poster

Access PCI education on Medtronic Academy.

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™Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

^†

Bench test data may not be indicative of clinical performance.

References

Sambu N, Fernandez J, Shah NC, O’Kane P. The GuideLiner®: An interventionist's experience of their first 50 cases: "The mostly good, rarely bad, beware of the ugly!" Interv. Cardiol. August 2013;5(4):389–404.

Based on guide catheter and aspiration catheter market share reports and data on file at Medtronic.

Deliverability bench testing^†: Telescope™ GEC 6 F vs. GuideLiner™* V3 GEC 5.5 F/6 F vs. Guidezilla™* II GEC 6 F. Differences among the means are significant if p < 0.05. N = 8 for each GEC tested. 10 test cycles per GEC. Results measure maximum force.

⁴

Pushability bench testing^†: Telescope™ GEC 6 F vs. GuideLiner™* V3 GEC 6 F vs. Guidezilla™* II GEC 6 F. Differences among the means are significant if p <0.05. N = 8 for each GEC tested. Results measure maximum force.

⁵

Soft tip compression bench testing^†: Telescope™ GEC 6 F vs. GuideLiner™* V3 GEC 5.5 F/6 F vs. Guidezilla™* II GEC 6 F. Differences among the means are significant if p <0.05. N = 8 for each GEC tested. Results measure maximum force.

⁶

Based on the Telescope GEC design freeze document (internal design document).

Indications, Safety, and Warnings Telescope™ Guide Extension Catheter