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Benvenue Medical develops next generation minimally invasive expandable implant systems for the spine, supported  by clinical data.

Benvenue has developed next-generation, minimally invasive implants and devices for the spine based on proprietary flexible PEEK-OPTIMA® and pre-shaped Nitinol technologies.  Kiva is a unipedicular, PEEK-OPTIMA® implant, solution for vertebral augmentation and a departure from balloon kyphoplasty making it the first new approach to the treatment of vertebral compression fractures in over a decade.  These innovative technologies also provide a platform for the development of other spinal therapies, such as minimally invasive spinal fusion for treatment of degenerative disc disease.

Benvenue Medical has successfully designed and brought to market two systems that are currently being used for the treatment of vertebral compression fractures in the United States and Europe -  Kiva VCF Treatment System and the Blazer – C Vertebral Augmentation System.

Kiva and Blazer – C are cleared by the FDA for distribution in the United States.  Kiva also bears the CE Mark for distribution in the European Union.

The Kiva VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5.  It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit. As with other vertebral augmentation devices and procedures, there are risks and considerations for use of the Kiva VCF Treatment System.  The risks include serious complications up to and including death.  Please see the product labeling for a more detailed discussion of risks, contraindications, warnings and precautions.  Consult a healthcare provider regarding specific treatment options.


Kiva VCF Treatment System

Small Implant. BIG IMPACT.

The Kiva VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. It is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

The Kiva System features a proprietary flexible implant made from PEEK-OPTIMA®, a biocompatible polymer that is widely used and well accepted as a spinal implant. The Kiva implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement during vertebral augmentation. The implant is delivered percutaneously over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered is physician-customized during the procedure. View Animation

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  • Product Features

    Kiva is a unipedicular, PEEK-OPTIMA® implant, solution for vertebral augmentation and a departure from balloon kyphoplasty making it the first new approach to the treatment of vertebral compression fractures in over a decade. Kiva has been demonstrated to meet or exceed the performance of balloon kyphoplasty (BKP) in three separate comparative studies(24,25,26). In one or more of these studies, as compared to BKP, Kiva was shown to:

    • Reduce rate of adjacent level fracture
    • Improve kyphotic angle restoration
    • Reduce rate of cement extravasation
    • Reduce the cement volume

    The Kiva VCF System features a deployment device that allows the treating physician to seamlessly deliver the implant to the patient through one small incision.  Unlike with balloon kyphoplasty systems, this device does not require a bi-pedicular approach and it does not require the treating physician to deflate a balloon in order to fill the vertebral body with cement.  With the Kiva VCF Treatment System, the physician connects and delivers the cement without removing anything from the vertebral body, reducing the need for added steps.  In clinical studies, the Kiva System was shown to meet or exceed the performance of balloon kyphoplasty in subsequent fracture rates, cement extravasation (leakage) rates and pain/function scores.


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    Cylindrical Implant Design

    • Stabilizes fracture with less amount of bone cement
    • Implant design acts as cement restrictor
    • Implant directs cement flow centrally
    • Physician customizes the amount of implant delivered into fracture

    PEEK-OPTIMA® Implant Material

    • More similar to cortical bone than PMMA
    • Even with PMMA, 50% less stiff than PMMA alone
    • Biocompatible
    • Radiopaque

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    Nitinol Kiva Coil

    • Pre-shaped Nitinol wire retains its stacked coil configuration
    • Creates a channel within the cancellous bone for implant deployment
    • Radiopaque and highly visible under fluoro

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    MIS, Unilateral Approach

    • Kiva is delivered through a transpedicular approach
  • Procedure Details

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    Four Simple steps:

    1. Unipedicular Access
    2. Deployment of Implant
    3. Delivery of Cement
    4. Removal of the device

The Kiva VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5.  It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

As with other vertebral augmentation devices and procedures, there are risks and considerations for use of the Kiva VCF Treatment System.  The risks include serious complications up to and including death.  Please see the product labeling for a more detailed discussion of risks, contraindications, warnings and precautions.  Consult a healthcare provider regarding specific treatment options.


Luna® 360 Interbody Fusion System

Lumbar Fusion Ingenuity ON THE RISE

Luna 360 Implant is an in-situ expandable PEEK-OPTIMA® interbody implant that forms an ALIF footprint from a mini-open or MIS posterior approach. Designed to provide anterior column stability, strength and fusion with minimal neural retraction, the Luna 360 Implant features a controlled, non-impaction delivery and a generous graft window that allows bone grafting material to be inserted post-expansion.

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  • Product Features

    The Luna 360 System is a novel, minimally invasive lumbar interbody fusion device for degenerative disc disease that incorporates Benvenue Medical’s proprietary material science expertise and manufacturing capabilities. Luna incorporates PEEK-OPTIMA and nitinol to develop a revolutionary interbody implant that is precisely guided, controlled and a less invasive technique to the lumbar spine.


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    360 Degree In-Situ Expandable Implant

    • Luna is a large circular implant that goes where a small rectangular device used to be placed
    • Provides spine surgeons a small access cannula for posterior access, and the implant expands in the vertebral disc space to a large footprint with minimal neural retraction
    • Incorporates the benefits of ALIF cage size with a controlled and guided posterior delivery

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    Ingenious Design Defines New Standards for MIS Spine Surgery

    • Uses well established interventional delivery methods
    • Deployment cables for controlled navigation and reproducible insertion
    • Proprietary machining of PEEK-OPTIMA for flexibility and expansion in-situ
  • Procedure Details

    The Luna 360 Implant Four-Step Process:

    1. Deploy... through a minimal, posterior lumbar interbody fusion approach
    2. Expand... in-situ and vertically within the disc space to restore disc height up to 13mm
    3. Insert... graft, allowing surgeons to maximize the volume of bone graft post-Luna expansion
    4. Lock... the implant, securing the 360 degree construct

The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 Interbody Fusion System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 Interbody Fusion System is to be used with supplemental fixation.

As with other lumbar fusion devices and procedures, there are risks and considerations for use of the Luna 360 Interbody Fusion System.  Please see the product labeling for a detailed discussion of risks, contraindications, warnings and precautions.  Failure to follow any instructions or failure to heed any warnings or cautions could result in serious patient injury.


Blazer - C

Vertebral Augmentation System

Blazer - C is a vertebral augmentation system that utilizes a unique cannulated curved wire offering mechanical channel creation, predictable cement deposition across the entire vertebral body and an MIS unilateral approach.

Blazer - C allows the physician to control placement of the device and create channels providing cement coverage across the entire vertebral body. Blazer - C can be used to successfully treat pathological vertebral compression fractures including use in sclerotic bone, blastic lesions and chronic fractures.
View Animation

Blazer - C is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).

The Blazer - C Vertebral Augmentation System is available for sale in the United States.

  • Product Features

    Mechanical Channel Creation Via Nitinol Wire.

    The cannulated Blazer - C wire allows the physician to control placement of the device and create channels within the vertebral body where desired. Blazer - C can be used to treat pathological vertebral compression fractures including use in sclerotic bone, blastic lesions and chronic fractures.

    Blazer – C Tip Partially Deployed

    Blazer – C Tip Partially Deployed

    Blazer – C Tip – Fully Deployed

    Blazer – C Tip – Fully Deployed

    Blazer – C Tip Opening

    Blazer – C Tip Opening

    Predictable Cement Deposition Through Cannulated Wire.

    Cement flow follows the channels created by Blazer - C providing directional control during cement delivery through the cannulated tip of the Blazer – C wire.

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    Cement deposition with Blazer-C

    Cement deposition with Blazer-C

    MIS, Unilateral Approach.

    The Blazer - C wire is easy to advance and retract consistently.  The system is designed to provide complete vertebral body coverage via a unilateral approach.  It is available in 10G (3mm) outer diameter.

    Blazer – C Device and Initial Placement

    Blazer – C Device and Initial Placement

  • Procedure Details

    1. The vertebral body is accessed unilaterally, via a transpedicular approach using a single step introducer with working cannula.
    2. The Blazer – C is introduced through the working cannula and channels are created by deployment and retraction of the Blazer wire.
    3. Blazer – C is removed from the vertebral body, primed with bone cement, and re-inserted through the working cannula.
    4. Additional channels are created with the Blazer wire and cement is injected through the cannulated tip of the wire.

Blazer - C is indicated for the treatment of pathological compression fractures of the vertebral body that result from osteoporosis, benign lesions, or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).

As with other vertebral augmentation devices and procedures, there are risks and considerations for use of the Blazer Vertebral Augmentation System. The risks include serious complications up to and including death. Please see the product labeling for a more detailed discussion of risks, contraindications, warnings and precautions. Consult a healthcare provider regarding specific treatment options.



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