Products » Vascular Intervention » Peripheral Vascular

Peripheral Vascular

The TAPAS™ Catheter allows treatment of long peripheral vascular segments with only one device. You have the flexibility to select your therapeutic or diagnostic agent and dose, deliver locally, and aspirate post-treatment.

The TAPAS catheter is an innovative system featuring two compliant occlusion balloons enabling targeted local delivery of any physician-specified agent. The adjustable treatment zone expands up to 300mm, allowing for the treatment of long vessels with only one device. The medication can be aspirated out of the catheter after treatment, providing localized intravascular treatment without systemic run-off. The TAPAS catheter can be used in conjunction with Spectranetics’ laser atherectomy catheters or other interventional devices.

Primary Product Features

Treatment zone adjusts to lengths up to 300mm
Dual occlusive balloons to control delivery
Post-treatment aspiration
Proprietary heparin and hydrophilic coating

Primary Product Benefits

Allows delivery of any therapeutic or diagnostic agent
Treats long vessels with only one device
Provides localized intravascular treatment without systemic run-off
One device can be used to treat multiple segments and vessels

View TAPAS Sizing Chart

Indications

The TAPAS Catheter is intended for general intravascular use in the peripheral vasculature in arteries 1.8mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

Contraindications

The TAPAS Catheter is contraindicated for use in coronary and intracranial arteries.
The TAPAS Catheter is not intended for embolic protection or as an aspiration catheter.
It is the responsibility of the physician to determine whether any physical impairment of the patient would contraindicate the use of this device.

Adverse Events

Peripheral interventions or any other surgical procedure has inherent risks. For a complete listing, see the IFU.

Warnings

The device is intended for one time use. DO NOT resterilize and/or reuse it, as this can potentially result in compromised device performance and increased risk of inappropriate resterilization and cross contamination.
Do not use any unit if its package is open or damaged.
To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel at the desired site of occlusion.
Maximum listed balloon inflation volume should not be exceeded. Inflation in excess of the maximum listed inflation volume may cause the balloon to rupture. The inflation volume is based on the results of in-vitro testing. Use of an inflation device with adequate inflation volume resolution is recommended.
Use the catheter prior to the “Use Before” date specified on the package label.
Do not exceed 250psi injection pressure through the POB Infusion Lumen Extension (red band).

Precautions

The size of the inflated balloon should be selected not to exceed the diameter of the artery immediately distal or proximal to the selected occlusion site.
To minimize the possible introduction of air into the system, it is imperative that prior to proceeding, careful attention is paid to the maintenance of tight catheter connections and thorough aspiration and flushing of the system.
Debubble each tubing connection, purge air from the catheter and all connecting tubing when connecting to any external devices per manufacturers’ instructions.
Do not infuse against a blocked catheter or closed stopcock: excess pressure may cause connections to separate.
Use the recommended balloon inflation medium (50% contrast medium/50% saline solution). Never use air or other gaseous medium to inflate the balloons while inside a patient.
Use of the TAPAS Catheter should be performed only under fluoroscopic observation with radiographic equipment that provides high resolution images.
Do not advance any portion of the catheter system against significant resistance. The cause of resistance should be determined via fluoroscopy and remedial action taken.
The medical techniques and procedures described in these instructions are presented as an example only, and do not represent all medically acceptable protocols. They are not intended as a substitute for physicians experience and judgment in treating any specific patient.