Penumbra System User Guide Rev B

3

Aspiration Pump Set-up 1

Attach Filter to Aspiration Pump.

5

Connect Pump Canister Tubing from center of Canister Lid to Filter

6

Open Aspiration Tubing (Sterile) onto sterile field. Flow Switch is set to Off

7

Attach blue connector on Aspiration Tubing (Sterile) to port marked with blue sticker on Canister Lid.

Do not over tighten or cross thread the filter.

2

Place Canister Lid onto Canister. Significant pressure may be necessary to click Canister Lid into place.

3

Place the white insert into the canister well in the aspiration pump.

4

Place Canister with Lid into Aspiration Pump

1 ATTACH FILTER HERE

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ASPIRATION PUMP

CANISTER ON/OFF SWITCH FILTER

INSERT PUMP CANISTER TUBING

FLOW SWITCH

CANISTER LID

Do Not Discard TO PATIENT ASPIRATION TUBING STERILE

Set-up

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Aspiration Pump Set-up 8

Turn on Aspiration Pump and check that gauge is reading between -20 to -25 in Hg. Check that all connections and Canister Lid are secure. All ports on the Canister Lid should be closed. Assure regulator knob is fully turned Clockwise

9

Position Aspiration Pump so the full length of the Canister is visible to physician.

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8

Set-up

6

Reperfusion Catheter and Separator Size Selection 1

Select the largest Reperfusion Catheter / Separator pair that will access the treatment site without occluding the vessel. ICA, M1, Vertebral, Basilar (vessels larger than 3mm): Use 041 Reperfusion Catheter/Separator pair M2, P1 (vessels 2mm-3mm): Use 032 Reperfusion Catheter/Separator pair M3 (vessels less than 2mm): Use 026 Reperfusion Catheter/Separator pair Always use a matched size Separator / Reperfusion Catheter pair.

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Vessel Size

Separator/Reperfusion Catheter Size Selection

(mm) < 2.0

026

2.0 - 3.0

032

> 3.0

041

Minimum Guide Catheter ID = 0.065”

Clinical Use Clinical Use

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Access Guidelines 1

Select a 6F or larger femoral sheath.

2

Select a Guide Catheter with a .065” lumen or larger. Technical Tip: The Neuron 6F 070 Delivery Catheter placed in the petrous anatomy may facilitate access.

3

Standard 0.014” Neurovascular guidewires should facilitate access in most cases. Technical Tip: Larger diameter wires can be used to assist tracking. Technical Tip: Steam shaping of the Reperfusion Catheter Tip may assist tracking. All Penumbra Reperfusion Catheters are steam shapable. Technical Tip: A tri-axial system comprised of a “10” or “18” neurovascular microcatheter and guidewire through the 041 Reperfusion Catheter can help optimize access performance. Technical Tip: Tri-axial technique may require that RHV be removed from 041 Reperfusion Catheter to allow microcatheter to extend far enough to aid in access.

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10

Prepare Penumbra System for Aspiration 1

Place Reperfusion Catheter in vessel immediately proximal to occlusion. If the triaxial system was used, re-attach the RHV on to the Reperfusion Catheter hub.

2

Remove Guidewire from the Reperfusion Catheter.

3

Introduce matching Separator using light blue colored Penumbra introducer.

4

Set up the Separator for optimal throw within the Reperfusion Catheter. a. Place a torque device on proximal end of Separator. b. Tighten torque device against the RHV hub so that radiopaque marker on Separator Bulb extends approximately 4mm past the radiopaque marker on the Reperfusion Catheter.

1

4 TORQUE DEVICE

RHV HUB

Clinical Use

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Prepare Penumbra System for Aspiration 5

Connect Reperfusion Catheter to Aspiration Tubing (Sterile) by attaching male luer lock to side port of RHV. Blue Female end of Aspiration Tubing (Sterile) should be attached to the port on Canister Lid indicated by blue sticker RHV should not be so tight that Separator movement is impeded.

6

Turn Aspiration Pump on. 6

12

5

ASPIRATION TUBING (STERILE)

RHV SIDE PORT

6

Clinical Use

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14

Thrombus Removal 1 Set flow switch on Aspiration Tubing (Sterile) to the

5

Clean Catheter Tip: When flow stops or slows, use the Separator to clear the Reperfusion Catheter tip by moving the Separator in and out of Reperfusion Catheter.

6

Flush Clot Pieces: The Separator cone must extend beyond the distal tip of the Reperfusion Catheter to allow aspiration of ingested clot.

“ON” or green position.

2 Observe and note baseline aspiration flow rate in

both the Aspiration Tubing (sterile) and dripping in the Canister.

3 Position Separator such that the radiopaque marker on the Separator is approximately 4mm distal to the radiopaque marker on the Reperfusion Catheter. Separator movement should be kept short enough (<2cm) so that the Separator’s midshaft (green in color) does not exit RHV.

4 Ingest Clot: Advance Reperfusion Catheter until aspiration flow slows or stops in the Aspiration Tubing (sterile) and/or the pump Canister.

Increased friction between Separator and Reperfusion Catheter may indicate thrombus has become lodged in one or both devices. Remove and thoroughly clean both devices. If friction or fatigue persists, replace one or both with new devices. See “Tips” on page 18.

3

4

Floppy platinum coil at distal tip Marker under polymer bulb Tip of 026 Reperfusion Catheter

INGEST CLOT Image courtesy of Drs. Jansen and Alfke, Kiel, Germany

5

6

CLEAN CATHETER TIP

FLUSH CLOT PIECES

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Tips

Aspiration Optimization Techniques 1

Reperfusion Catheter Does Not Clear After Several Separator Movements If after one (1) minute of performing the procedure in steps 4-6 above under Thrombus Removal, the Reperfusion Catheter cannot be cleared, and aspiration flow cannot be re-established, perform the following to help clear the Reperfusion Catheter: a. Retract the tip of the Reperfusion Catheter proximal to the thrombus to an open segment of the artery. b. Repeat the movement of the Separator as in steps 4-6 above in Thrombus Removal. c. If flow is still not re-established, remove Separator from the Reperfusion Catheter and inspect, and wipe down any adherent material.

d. If flow is not re-established after removing the Separator, the Reperfusion Catheter should be removed, inspected for damage, flushed on the table, or replaced. e. The system should be re-introduced as described in Access Guidelines on Page 10.

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1

Separator 041 with adherent thrombus.

Tips

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Aspiration Optimization Techniques

2 Reperfusion Catheter is Unable to Maintain Stable Position at Proximal Face of Thrombus If the Reperfusion Catheter is unable to maintain a stable position at the proximal surface of the thrombus, you may elect to move to a more distal position. a. Place the Reperfusion Catheter within the thrombus using standard access techniques. b. Begin aspirating. c. Use the Separator to clear the Reperfusion Catheter as discussed in steps 4-6 above in Thrombus Removal. Technical Tip: The Reperfusion Catheter may need to be repositioned proximal to thrombus in an open vessel to achieve optimal aspiration of ingested clot.

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General Penumbra System Guidelines

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Revascularization is rarely immediate. • The median time required for revascularization in the Penumbra System Pivotal Trial was 45 minutes. • Up to 500cc of blood have been aspirated before revascularization was achieved. • Fibrin rich or highly adherent thrombus – from patients with Atrial Fibrillation or Congestive Heart Failure – may require more time and/or additional cleaning of Penumbra System components outside the body. Proximal flow is critical to aiding in revascularization • If the patient exhibits a proximal flow-limiting stenosis, intervention to improve proximal flow should be considered prior to aspiration.

Penumbra, Inc. USA 1351 Harbor Bay Pkwy Alameda, CA 94502 USA

Penumbra, Inc. Europe Westfalendamm 98 D-44141 Dortmund Germany

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T: +49-231-5598-318 F: +49-231-5598-111 order@penumbrainc.de info@penumbrainc.de

Copyright © 2008 by Penumbra, Inc. All rights reserved.

2166 Rev. B