About Elevate
Elevate, Apical and Posterior, is a minimally invasive, comprehensive solution to treat apical and posterior defects. Elevate utilizes self-fixating tips that allow for safe, simple and precise mesh placement in the sacrospinous ligament through a single vaginal incision.
Total transvaginal approach with no external incisions, eliminating the potential for associated buttock pain. The single incision may reduce procedure time and provides the potential for a shorter recovery period for the patient.
There are no blind needle passes potentially minimizing bowel injury and reducing tissue/levator trauma. Protective sheath on delivery needle incorporates a depth limiting feature and is designed to allow tactile feedback for safe and accurate placement in the sacrospinous ligament.
Elevate Posterior Features and Benefits
- Anatomically designed, 2.4mm needle with protective sheath and depth limiting feature
- Enhances recovery and provides smooth passage and potentially minimizes tissue trauma and neurovascular injury.
- Small, integrated self-fixating tips
- Provides strong holding force and prevents migration during initial tissue fixation and ingrowth.
- Fixating Arms and Mesh
- Fixating arms facilitate easy mesh placement and interoperative tensioning. Allows for efficient tensioning and adjustment to individual anatomies.
- Release mechanism facilitates ease of use and retracts protective sheath for easy needle deployment
- Simplifies procedure and allows for smooth passage and easy needle deployment into sacrospinous ligament.
Graft Choices
Elevate allows you to choose from a biologic** or synthetic graft to meet individual patient needs.
IntePro® Lite™ Mesh (Synthetic)
Low density results in less implanted foreign material in the body. IntePro Lite is pliable and is designed to improve vaginal mobility and allow for better anatomical conformity.
InteXen® LP™ (Biologic)**
A soft, pliable biomaterial that conforms to patient anatomy. It can be tailored to meet the needs of patients who may be at high risk for complications from synthetics.
** Limited Market Availability
Results
Single-arm, prospective, multi-center trial of 139 patients with POP-Q stage II or greater apical and/or posterior prolapse implanted with Elevate Apical and Posterior device.
Elevate Apical & Posterior 24 Mo Follow-Up
Lukban J, et al; as presented at ICS 2011
Design: Prospective, multi-center study, 139 patients (113 at 24 mo follow-up)
Complications: 7.9% mesh erosion (no explants), 2.2% constipation and buttock pain (each), 1.4% vaginal infection, hematoma, UTI and superficial would dehiscence (each), All other complications <1%
Conclusion: Elevate Apical and Posterior was shown to provide long term safety and effectiveness.
For additional Elevate data click here
Elevate Posterior Procedure
Animation Video
Surgical Video
Training Opportunities
Training opportunities are now available. Please contact your AMS sales representative or AMS Physician Training Department at (800) 328-3881 for more information.
Patient Information
AMS offers patient counseling brochures for physicians who perform prolapse procedures using synthetic mesh.
Contact your AMS Sales Representative for ordering information
Risks and Precautions
Summary of Warnings, Precautions and Contraindications
for the Elevate Apical and Posterior Prolapse Repair System
As with any surgical procedure, inherent risks are present. Some of the most severe risks associated with the Elevate procedure include perforation of the urethra, bladder and bowel, erosion of the mesh through neighboring tissue, and infection. If infection or erosion occur, the entire mesh may have to be removed or revised. Prolapse repair may unmask pre-existing incontinence.
For a complete list of indications, contraindications, warnings and precautions, refer to the product Instructions for Use or contact your AMS representative. This document is written for professional medical audiences. Contact AMS for lay publications. AMS periodically updates product literature. If you have questions regarding the currency of this information, please contact AMS.
Reimbursement
AMS Healthcare Affairs (HCA) is continuously working with public and private healthcare companies, Centers for Medicare & Medicaid Services (CMS), industry advocates, and others to ensure appropriate reimbursement for our products.
Call HCA at (888) 865-3373 to speak with a dedicated reimbursement analyst.