REPEL-CV® Bioresorbable Adhesion Barrier reduces the severity of post-operative cardiac adhesions in pediatric patients.
In a randomized, controlled, clinical trial conducted at 15 pediatric cardiothoracic surgery centers, REPEL-CV Bioresorbable Adhesion Barrier was placed over the surface of the heart at the conclusion of an open heart surgery procedure to minimize the formation of post-operative adhesions. Once in place, it acts as a temporary barrier to physically separate opposing surfaces to reduce the risk of their becoming connected through the formation of fibrin bands during the early phase of wound healing. By placing REPEL-CV Adhesion Barrier between the traumatized tissue surfaces, the formation of the interconnecting fibrinous bands between adjacent surfaces is blocked and the development of fibrinous adhesions is reduced. It is then absorbed at the implant site in approximately one month.
Using REPEL-CV Adhesion Barrier minimizes the need for lengthy adhesion dissection procedures, which may reduce the length of the surgical procedure and the patient's exposure to anesthesia and its associated risks.
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REPEL-CV® Adhesion Barrier features and benefits
Easy to use … Easy to prepare and apply, REPEL-CV Adhesion Barrier adds minimal time to the overall procedure. Simply cut the film to the required size, hydrate in Ringer's lactate or saline solution for a few minutes, conform the pliable film to the cardiac anatomy, and then secure it to the remaining pericardium. REPEL-CV Adhesion Barrier does not require placement on a dry surgical field.
No change in surgical procedure … Because REPEL-CV Adhesion Barrier is easily incorporated into the procedural routine, no special accommodations or training for its use are needed.
Full view of the surgical site … REPEL-CV Adhesion Barrier is a transparent film that does not impede the surgeon's full view of the surgical site during or after application, allowing visualization of key anatomical landmarks for safe and optimal placement.
Biocompatible … The polymer materials used in REPEL-CV Adhesion Barrier have been used in numerous other medical implants and are well recognized as safe and biocompatible.
Resorbable … REPEL-CV Adhesion Barrier is designed to perform the therapeutic task and then, due to exposure to moisture, degrade so that the polymer components are completely eliminated from the body in approximately one month.
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Watch a video of the REPEL-CV® Adhesion Barrier implantation procedure.
Clinical data
In a multi-center, randomized, controlled clinical trial of pediatric patients who underwent staged cardiac surgery:
- 70.4% of patients treated with REPEL-CV Adhesion Barrier were free from clinically significant adhesions at the point of the secondary surgical procedure. This compares with only 28.6% of the control patients.
- The mean extent, or average surface area coverage, of clinically significant adhesions was approximately 2.5 times greater in the control group as compared to the treated group.
Better patient outcomes may result from:
- Reduced risks associated with sternal re-entry and dissection of post-operative cardiac adhesions which expose the patient to critical risks and significantly higher complication rates1
- Reduced risk of severe hemorrhage with significant morbidity and mortality2
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Reduced exposure to anesthesia
Important Safety Information
REPEL-CV Adhesion Barrier is indicated for reducing the severity of post-operative cardiac adhesions in pediatric patients who are likely to require reoperation via sternotomy. In the multi-center clinical trial referenced above, the safety assessment showed that the frequency of adverse events was similar between the REPEL-CV treated group and the control group and was representative of adverse events expected for this high-risk patient population. For additional information on precautions and adverse events, please see the package insert.
Ordering information
REPEL-CV Adhesion Barrier
| Description | Size |
| 1 box containing 3 sterile film packages | 18 cm x 13.5 cm x 137 microns |
| Product Code | Usage Location |
| SYN 001 | International* |
| SYN 002 | Canada |
| SYN 003 | United States |
*Excluding Canada
For more information or to order REPEL-CV Adhesion Barrier, please call: 1-888-SYNTHEMED (1-888-796-8436).
Click here if you would prefer to electronically receive additional information.
View the REPEL-CV® Adhesion Barrier Product Brochure (PDF 3.5MB)
View a summary chart of the instructions for using REPEL-CV® Adhesion Barrier (PDF 161KB)
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References
1Follis FM, Pett SB Jr., Miller KB, et al. Catastrophic hemorrhage on sternal reentry: still a dreaded complication? Ann Thorac Surg. 1999;68:2215-2219.
2Elahi M, Dhannapuneni R, Firmin R, Hickey M. Direct Complications of Repeat Median Sternotomy in Adults. Asian Cardiovasc Thorac Annals. 2005;13(2):135-138.
