Penditure™ LAA Exclusion System 

for LEFT ATRIAL APPENDAGE MANAGEMENT

Penditure LAA exclusion system consists of a single-use, sterile, self-closing implant (clip) preloaded on a disposable delivery system.

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Alert Indications, Safety, and Warnings

Overview

The Penditure LAA exclusion system consists of a single-use, sterile, self-closing implant (clip) preloaded on a disposable delivery system. The implantable clip comes in four sizes: 35 mm, 40 mm, 45 mm, and 50 mm. The Penditure LAA exclusion system clip is designed to be permanently implanted at the base of the LAA.

Design features

  • Fabric-free design for atraumatic closure and reduced risk of inflammation1
  • Tip-first closure helps provide complete and secure exclusion of the appendage2
  • Curved clip to better match the atrial anatomy3
  • Recapturable, redeployable, and repositionable after deployment to ensure precise placement2
  • Wide opening at the base offers good visibility, which may assist in proper clip placement4
Close-up of Penditure™ LAA exclusion system tip with a pink circle around it

Product details

  1. Rotation knob ± 90°
  2. 11 cm bendable, rotatable aluminum shaft
  3. Implantable clip with a slight curve to match the atrial anatomy3
  4. 16.8 cm working length
  5. Recapturable and redeployable clip feature
  6. Pins
  7. Release trigger | Single-button deployment
  8. Actuation (opening) lever
  9. Handle
Penditure™ LAA exclusion system with the numbers one through nine as callouts to highlight specific features

Cross-section of the left atrial appendage with a clip and a full view of the heart with clip

Animal data

Purpose and objectives

The objective of this study was to demonstrate substantial equivalence of the Penditure LAA exclusion system to the AtriClip™* Flex-V™* exclusion system when compared in a canine model 90 days after the procedure.

Study design

This Good Laboratory Practices (GLP) study was designed to evaluate the performance and safety of the study device (Penditure) in comparison to the control device (AtriClip Flex-V) in a canine model over 90 days. Twelve mongrel dogs (age range: 10.4–33.6 months) were enrolled in the study. A canine model was chosen because heart size, electrophysiological characteristics, and hemodynamics have been shown to be comparable to those of the human heart.

Six animals were assigned to the Penditure device, and six were assigned to the AtriClip Flex-V device for the 90–day study. A clinical user (interventionalist) performed the implantations.

For each animal, a thoracotomy was performed to expose the LAA. The study or control device was implanted on the LAA. One study or device was implanted per animal. Fluoroscopy was used for guidance.

Transesophageal echocardiography (TEE) was performed post-implantation to evaluate device placement and to confirm LAA closure. Fluoroscopy was also performed for quantitative measurement of the distance between the straight metal segments of the clips to approximate tissue thickness in vivo.

At 7 days and 90 days (before euthanasia) post-implantation, TEE was performed again to evaluate device placement, confirm LAA closure, and document any abnormalities. Fluoroscopy was performed for quantitative measurement of the distance between the straight metal segments of the clips to approximate tissue thickness in vivo.

After the animals were euthanized, a pathological gross examination was performed, and the heart, implant, and major organs (brain, liver, kidney, spleen, lungs) were saved for histopathologic analysis by a veterinary pathologist. Inspection and photographic documentation of the LAA (both external and intra-atrial views) were performed. The clips and surrounding tissue underwent processing for histopathologic evaluation.

Results

Six mongrel dogs were successfully implanted with the Penditure device, and six mongrel dogs were successfully implanted with the AtriClip Flex-V device.

No complications or procedural events occurred at implantation.

Conclusion

  • The Penditure LAA exclusion system showed a good safety profile without evidence of significant adverse effects
  • Gross necropsy evaluation showed a smooth endocardial surface with no visible opening to the left atrium and LAA
  • The gross necropsy results appeared to be better in the Penditure group, and the microCT results were similar in both groups
  • The histopathology results appeared to be better in the Penditure devices than in the AtriClip Flex-V
  • Penditure demonstrated substantial equivalence to AtriClip Flex-V
Download animal study summary

Indications

The Penditure LAA exclusion system is indicated for the exclusion of the left atrial appendage of the heart, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Manuals and technical guides

See Instructions for Use.

Ordering information

Penditure™ LAA exclusion system selection guide being used on the left atrial appendage in the heart
Four tip lengths of the Penditure™ LAA exclusion — 35 mm, 40 mm, 45 mm, and 50 mm — system stacked on top of each other
Penditure™ LAA exclusion system tip with the letters A, B, C, and D as callouts to highlight specific features

 

CFN

Length (A)

Width (B)

Height (C)

Opening (D)†

LAAC35
35 mm

39.6 mm

6.9 mm

11 mm

19.0 mm

LAAC40
40 mm

44.6 mm

7.4 mm 

11 mm

19.9 mm

LAAC45
45 mm

50.0 mm

8.1 mm

11 mm

23.2 mm

LAAC50
50 mm

55.0 mm

8.8 mm

11 mm

20.0 mm

LAACSIZER

Packaged separately (3/pk)

Penditure clips are textured PEEK material with a subtle curve (radius) at the distal tip. Nitinol springs provide the closing force.

†Implant tip opening is a function of the moment arm and force of the spring. The location where spring force acts is further from the delivery system with longer clips. The result is that tip openings vary, and may not be consistent, with clip size.

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Possible complications related to the use of Penditure™ LAA exclusion system in combination with open heart surgery are: bleeding, tissue damage, thromboembolism, and pericardial effusion. For a complete listing of all indications, contraindications, precautions, and warnings, please refer to the Instructions for Use, which accompany each product.

For more information, contact your local Medtronic surgical ablation representative. U.S. Customer Service: 800-328-1357

Only physicians who are trained in standard cardiac surgical procedures can use this device.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.

*

Third-party brands are trademarks of their respective owners.

References

1

Medtronic data on file: GLP Animal Study Report TR-00023. These tests may not be indicative of clinical performance.

2

Medtronic data on file: Product Specification Matrix PRS-00001. These tests may not be indicative of clinical performance.

3

Medtronic data on file: Product Specification Matrix PRS-00001 and Curvature report EGS-00006. These tests may not be indicative of clinical performance. 

4

Medtronic data on file: VOC August 29, 2023, may not be indicative of clinical performance.