Augmenta Vertebral Augmentation Device ( VAD)

The Augmenta VAD provides a cost-effective and efficient method for performing vertebral augmentation with an advanced engineered device. The Augmenta VAD eliminates the need for complicated back table preparations and costly dye purchase. Additional void-creating equipment is not needed when performing vertebral augmentation.

ADVANTAGES OF AUGMENTA VAD

  • Cost effective
  • Full vertebral coverage from unipedicular approach (faster)
  • Tactile feel with directable tamp
  • Creates predictable voids that do not require refracture of the vertebral body
  • Creates voids in all four quadrants of vertebral body if needed or desirable
  • Controlled voids greatly reduce cement extravasation (safer)
  • Voids help direct cement to where it is needed (safer)
  • Tamp creates voids and leaves remaining cancellous bone uncompressed
  • Cannula side port directs cement in a directional fashion
  • Fracture reduction optional
  • Cement selection per physician
  • Instrumentation is minimal but powerful and elegant
The Augmenta VAD is packaged and commercialized as a system consisting of three components: the bone tamp, outer cannula and the stiffener,
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Augmenta VAD Procedure

THE AUGMENTA VAD PROCEDURE

  1. Position the outer cannula with the internal stiffener device fluoroscopically at the desired vertebral position.
  2. Use the outer cannula and the stiffener to create a channel through which the bone tamp and bone cement of choice can be passed.
  3. Use of the stiffener with the outer cannula can provide additional support/reinforcement to the cannula during insertion of the outer cannula into the targeted vertebral body.
  4. Use the bone tamp to create voids in the cancellous bone into which the bone cement will be positioned.
  5. The bone tamp can be positioned in multiple directions and levels to create the desired voids in all quadrants of the vertebra as necessary. Fracture reduction can be urged by tamping up the subchondral bone if desired.
  6. Introduce the selected bone cement into the voids created earlier in the procedure.

Note: The Augmenta VAD is not packaged with any bone cement, under Augmenta’s label or otherwise; any bone cement that is legally marketed in the U.S. under FDA regulations can be used with the Augmenta VAD. Choice of appropriate bone cement for a specific procedure is left to the discretion of the orthopedic surgeon.

ARTICLES

Dr. Mitchell Interview, The Orthopreneur.

PUBLICATIONS

F. Borgström, et al., Health economic aspects of vertebral augmentation procedures. Osteoporos Int DOI 10.1007/s00198-014-2953-5

PAPERS

F. Borgström, et al., Health economic aspects of vertebral augmentation procedures. Osteoporos Int DOI 10.1007/s00198-014-2953-5

V. Goz, et al., Kyphoplasty and vertebroplasty: trends in use in ambulatory and inpatient settings. The Spine Journal 11 (2011) 737-744.

Vertebral Augmentation with a Flexible Curved Needle: Preliminary Results in 17 Consecutive Patients, Journal of Vascular and Interventional Radiology, vol. 19, 12 , Dec. 2008

 

Augmenta VAD procedure

AP radiographic video of Augmenta procedure

Lateral radiographic video of Augmenta procedure

  • Void created with Augmenta Spine devices
  • Controlled release of PMMA into the void with Augmenta Spine devices

About Us

Augmenta Spine is a medical device company that specializes in the development of new and innovative spinal treatments and implants.

DR. DAVID MITCHELL | FOUNDER, PRESIDENT AND CEO

Dr. Mitchell is a Board Certified orthopaedic surgeon, specializing in operative and non-operating spine treatments, vertebroplasty, kyphoplasty, Workers Compensation injuries, and spine orthopaedics. He graduated from the Medical University of South Carolina and University of North Carolina, Greensboro. Dr. Mitchell completed his spine fellowship at the Indiana Spine Group in Indianapolis. He is also an appointed Clinical Assistant Professor of Orthopaedics at the Medical University of South Carolina.

Dr. Mitchell has been treating spine fractures since 1992. Dr. Mitchell came up with the idea for the Augmenta VAD as a result of deficiencies and problems he saw with other kyphoplasty products on the market, namely balloon kyphoplasty products. He found that balloons are often unpredictable in the voids they create in vertebral bodies, offer less control in making voids, are complicated to use, and are expensive. The Augmenta VAD is a simple, elegant, effective alternative to other kyophoplasty devices.

Dr. Mitchell was the first physician in South Carolina to perform kyphoplasty in the office setting for Medicare patients in 2012. If a patient has a painful vertebral fracture, kyphoplasty in office is generally as safe as, and significantly less expensive than, the same procedure done in a hospital setting.

Dr. Mitchell is a Past President of the South Carolina Orthopaedic Association, a Past President of the South Carolina Spine Society, and has been certified by the American Academy of Orthopaedic Surgery since 1998.

Case Studies

CASE STUDY 1

77 year old woman with two month history of low back pain.

Case Study Date: July 2013

  • Recent MRI indicates acute compression fracture at L-5
  • Patient agreed to operative stabilization with Kyphoplasty.
  • Augmenta device was used and fracture stabilized at L-5.
  • Patient pain free after the outpatient procedure.
  • Augmenta tamp allowed void creation in fractured portions and directed cement into voids without extravasations.

PRE OPERATIVE

Lateral radiograph at the level of the patients pain

Saggital T2 MRI indicating an acute type fracture at L-5

Saggital T1 MRI indicating subchondral void at L-5

POST OPERATIVE

Lateral radiograph indicating excellent anterior and subchondral fill

AP Radiograph of L-5 with excellent fill from pedicle to pedicle using a unipedicular technique and directional bone tamp

CASE STUDY 2

45 year old man with chronic prednisone for rheumatoid disease

Case Study Date: July 2013

  • Multiple asymptomatic compression fractures in past
  • New compression fracture at L-1 has developed a pseudoarthrosis and, for several months, has continued to be very painful
  • Comparison films from March 21, 2013 indicate the compression fracture seen on July 25, 2013 is new
  • Kyphoplasty performed using the Augmenta VAD device
  • Patient has complete relief of back pain

PRE OPERATIVE

Lateral radiograph of compression fracture at L-1

AP radiograph of L-1 compression fracture

POST OPERATIVE

Lateral radiograph of L-1 showing excellent placement of cement

AP radiograph showing pedicle to pedicle subchondral void filling with

OUR OFFICE

Augmenta Spine, Inc.
109 Whites Mill Way
Spartanburg
South Carolina, 29307

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