Impella RP Flex™ with SmartAssist® Insertion Animation

This animation depicts the primary steps for femoral insertion of the Impella RP Flex™ with SmartAssist®. The Impella RP Flex with SmartAssist is designed for right-heart recovery and is indicated for use for up to 14 days. For more information, consult the Impella RP Flex with SmartAssist Instructions for Use manual at www.heartrecovery.com.

1. Gain access to the femoral vein.

• Using ultrasound, gain access to the femoral vein with a micropuncture needle and sheath kit. Exchange for a 5-8 Fr introducer sheath. Insert a 0.035” guidewire.
• Place hemostatic sutures around the sheath but do not secure the sutures yet.

2. Prepare the vasculature for insertion of the Impella RP Flex with SmartAssist.

• Flush the sheath per standard hospital practice and sequentially dilate the puncture using the 8, 12, 16, 20, and 23 Fr dilators in the Introducer kit.
• Insert the 23 Fr peel-away sheath. Ensure ACT >250 seconds. Remove the dilator and guidewire. Flush the sheath.
• Under fluoroscopic guidance advance a balloon-tipped pulmonary artery (PA) catheter into the femoral vein and navigate to the right or left pulmonary artery.
• Create a small “J” on the 0.027” Impella guidewire and advance into the pulmonary artery.
• Remove the PA catheter using a fixed-wire technique.

3. Insert the Impella RP Flex with SmartAssist.

• Backload the Impella RP Flex cannula onto the 0.027” guidewire through the red EasyGuide lumen. Once backloaded, remove the red EasyGuide lumen.
• Using fixed-wire technique under fluoroscopic guidance, advance the Impella RP Flex with SmartAssist through the sheath and into the inferior vena cava (IVC). Continue to advance the Impella RP Flex until the inlet is in the IVC and the outlet is above the pulmonic valve at the pulmonary artery bifurcation.
• Slowly remove the guidewire under fluoroscopic guidance.

4. Start support with the Impella RP Flex with SmartAssist.

• Start the Impella RP Flex at performance level (P-level) P-2.
• Slowly increase support to the desired P-level.

5. Secure the position of the Impella RP Flex with SmartAssist.

• Remove the sheath from the femoral vein and peel-away. Use fluoroscopy to ensure that the Impella outlet does not move.
• Slide the repositioning sheath into the vein under fluoroscopy, ensuring the Impella cannula does not move. Tighten the hemostatic suture. Advance the sterile sleeve and turn it clockwise to lock it to the suture hub.
• Confirm all slack has been removed. Tighten the Tuohy Borst valve by turning clockwise until finger-tight.
• If needed, maintain the suture hub angle with folded 4x4 gauze before placing the sterile dressing.
• Secure the Impella RP Flex with SmartAssist per hospital protocol.

Note: Do NOT clean the Impella handle or purge sidearm retainer with alcohol or alcohol-based products.