Companion Sheath

Designed to Enhance Your Single Access Experience¹

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Overview

High risk-PCI and AMI shock patients can present challenges and risks when inserting mechanical circulatory devices to support heart stabilization and recovery. The Impella® heart pumps Companion Sheath allows you to reduce the number of access sites and delivers single-access excellence leading to the potential for improved outcomes, fewer complications and lowering the risk of bleeding.¹

This single-access technique² enables clinicians to use one access site for both the Impella CP® and the 7Fr Companion Sheath.

Features for a Simple and Effective Way To Perform Revascularization

Confident Maneuverability

Enhanced guide catheter manipulation with greater compression resistance*
Complete sheath insertion enables optimal guide catheter usage
Minimal guide interaction with Impella catheter

Consistent Performance

Smoother insertion with 60% less dynamic friction*
Greater Impella catheter stability during procedure

Ability To Treat Those With Limited Vascular Access

Helpful in those with limited access site options due to peripheral arterial disease.

Single Access Solution - Benefits May Include¹

Studies support Single-Access Protective-PCI with Impella pumps benefits the patient in elective and urgent settings, providing stability and consistency of approach and outcomes.^1,2,3

Learn More About Single Access

Our Companion Sheath Is Optimized for Use With Impella

Additional Resources

Single Access Sheath Comparison

Learn more about specifications and features.

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Data Sheet

Learn more about the technical specifications.

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Order Information

Impella 7Fr Low Profile Companion Sheath

Package Unit: box of 1
Part Number: 1000440

Learn More About Impella Heart Pumps

Impella 5.5® with SmartAssist® Heart Pump

(2nd Generation)

A minimally invasive heart pump that delivers full support, allowing the heart to rest and enabling heart recovery

Impella RP®

The first percutaneous, single vascular access pump approved for right heart support

Impella Connect®

Secure, cloud-based, remote monitoring of Impella® devices' status for better patient outcomes

Indication and Safety Information EU

INDICATION FOR USE

The Impella Low Profile Companion Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

CONTRAINDICATIONS

Radial access is contraindicated if there is an abnormal Allen’s Test, radial pulse, or insufficient dual arterial supply.

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to: air embolism, infection, hematoma, bleeding, perforation or laceration of the vessel wall, thrombus formation, pseudo aneurysm formation, guide wire embolization, vessel spasm, and risks normally associated with percutaneous diagnostic and/or interventional procedures.

Manufacturing Information

Manufacturer (US):

Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095 U.S.A.
1-801-253-1600
U.S.A. Customer Service 1-800-356-3748

European Representative:

Merit Medical Ireland Ltd. Parkmore Business Park West,
Galway, Ireland
European Customer Service
+31 43 358 82 22
REF: X9PG700001/B

Manufactured for (US):

Abiomed, Inc.
22 Cherry Hill Drive
Danvers, MA 01923, USA
Voice: +1 978-646-1400
Email: [email protected]
Hotline: +1 800-422-8666

Manufactured for / Importer (EU):

Abiomed Europe GmbH
Neuenhofer Weg 3
52074 Aachen, Germany
Voice: +49 (0) 2418860-0
Email: [email protected]
Hotline: 00800 0 22 466 33

References

“Safety and Efficacy of SIngle-access Impella for High-risk percutaneous intervention (SHiP)”, Hakeem et al. Feb 2022. JACC. REF-2319
Single-access for Hi-Risk PCI (SHiP) technique”, Wollmuth et al. Wiley. July 2019. REF-0805
Gajanan G, et al. 2022 J Invasive Cardiol. 34 (3):E190-E195

*Compared to previous recommended sheath.

NPS-4721