The Jetstream Atherectomy System features:

• Active Aspiration: extracts debris without device removal, minimizing embolization risk.
• Debulking: to treat multiple lesion morphologies, including calcium, plaque or thrombus. 
• Luminal Gain: As reported in the Calcium Study, Jetstream's front-cutting, expandable blades created statistically significant luminal gain in severe and moderate calcium (post versus baseline IVUS measurements).
• Front-cutting: to immediately engage tight or occluded lesions.

The system is an innovative peripheral revascularization platform designed to restore flow through the many types of lesion morphologies encountered in peripheral arterial disease (PAD). System consists of a single-use catheter with control pod and a reusable, compact console power source that mounts to a standard I.V. stand

CONTRAINDICATIONS

None known. 

WARNINGS/PRECAUTIONS

Catheter WARNINGS

• Use room temperature infusate only. Use of heated infusate may lead to wrinkling, ballooning and/or bursting of the outer catheter sheath, which could lead to injury to the patient
• Operating the Catheter over a kinked guidewire may cause vessel damage or guidewire fracture.
• During treatment, do not allow the Catheter tip within 10.0 cm of spring tip portion of the guidewire. Interaction between the Catheter Tip and this portion of the guidewire may cause damage to or detachment of the guidewire tip or complicate guidewire management.
• The guidewire must be in place prior to operating the Catheter in the patient. Absence of the guidewire may lead to inability to steer the Catheter and cause potential vessel damage.
• If the guidewire is accidentally retracted into the device during placement or treatment, stop use, and remove the Catheter and the guidewire from the patient. Verify that the guidewire is not damaged before re-inserting the guidewire. If damage is noticed, replace the guidewire.
• Check the infusate bag frequently and replace when needed. Do not run the JETSTREAM System without infusate as this may cause device failure.
• Hold the guidewire firmly during Catheter retraction process. Failure to do so may result in guidewire rotation within the vessel, which could cause patient injury.
• Do not manipulate the Catheter against resistance unless the cause for that resistance has been determined.

Catheter PRECAUTIONS

• Do not bend or kink the Catheter during setup or during the procedure. This may damage the device and lead to device failure.
• Do not inject contrast while the device is activated.
• Use only listed compatible guidewires and introducers with the JETSTREAM System. The use of any supplies not listed as compatible may damage or compromise the performance of the JETSTREAM System

Console WARNINGS and PRECAUTIONS

WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth

• Do not open either pump door during operation of the System. Doing so could result in loss of aspiration and/or infusion and will halt device activation.
• Ensure the PVCN100 Console display is visible during the entire procedure.
• Observe normal safety practices associated with electrical/electronic medical equipment.
• Avoid excessive coiling or bending of the power cables during storage.
• Store the PVCN100 Console using appropriate care to prevent accidental damage.
• Do not place objects on the PV Console.
• Do not immerse the PV Console in liquids.

Potential adverse events associated with use of this device and other interventional catheters include, but are not limited to the following (alphabetical order):

• Abrupt or sub-acute closure
• Amputation
• Bleeding complications, access site
• Bleeding complications, non-access site
• Death
• Dissection
• Distal emboli
• Hypotension
• Infection or fever
• Minor burn
• Perforation
• Restenosis of the treated segment
• Vascular complications which may require surgical repair
• Thrombus                                                                                                                                                                                           
• Vasospasm