Left atrial appendage exclusion systems

Penditure™ LAA exclusion system

<p>The Penditure™&nbsp;LAA exclusion system was created with a simple vision: making clipping easier.</p>

Features

  • Fabric-free design for reduced risk of inflammation1
  • Tip-first closure helps provide more complete and secure exclusion of the LAA2
  • Curved clip to better match the atrial anatomy2
  • Penditure clip is recapturable, redeployable, and repositionable after deployment to ensure precise placement2
  • Wide opening at the base offers good visibility, which may assist in proper clip placement
This is an image of the clip portion of the Penditure™ LAA exclusion system.

Product details

  1. Rotation knob ± 90°
  2. 11 cm bendable, rotatable aluminum shaft
  3. Implantable clip
  4. 16.8 cm working length
  5. Recapture and redeployment mechanism
  6. Pins
  7. Release trigger, single-button deployment
  8. Actuation (opening) lever
  9. Handle
This image shows the Penditure™ LAA exclusion system with callouts to highlight specific features.
This image shows the cross section of the left atrial appendage (LAA) 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™* devices
  • The Penditure™ device demonstrated substantial equivalence to AtriClip™* Flex-V™* device

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.

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.


This image shows the four different tip lengths of the Penditure™ LAA exclusion system
This image shows the tip of the Penditure™ LAA exclusion system with callouts to highlight specific parts.

Ordering information

Item number Usable length (mm) Length A (mm) Height B (mm) Width C (mm) Opening D (mm)
LAAC35 35 39.6 11 7.1 19.0
LAAC40 40 44.6 11 7.3 19.9
LAAC45 45 50.0 11 7.9 23.2
LAAC50 50 55.0 11 8.6 20.0
LAACSIZER Packaged separately, pack of 3

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.

TM* Third-party brands are trademarks of their respective owners.

  1. Medtronic animal testing on file, may not be indicative of clinical performance.
  2. Medtronic data on file.