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Frequently Asked Questions

Below you will find links to Frequently Asked Questions (FAQs) on our products. To view the FAQs locate your product in the table below and click the FAQ link beside it.

EZflow® Cement Delivery System
General Bone Cement Questions
TRACERS® Bone Cement Opacifier
SECOUR® Acrylic Resin
Parallax Acrylic Resin with TRACERS-Ta (Tantalum Opacifier)
Parallax Acrylic Resin with TRACERS (Barium Sulfate Opacifier)
CLEAR-VIEW® Needles (11ga and 13ga)
CORE-ASSURE® Bone Biopsy Kits

General Parallax Questions


Please review general information about Parallax


What are the indications and contraindications for vertebroplasty?


Indications:

Painful Fractures

  • Osteoporotic fracture refractory to medical therapy
  • Benign or malignant tumor: hemangioma, multiple myeloma, metastatic lesion
  • Osteonecrosis

Unstable Fractures

  • Unstable fractures with movement at wedge deformity
  • Multiple thoracic compression deformities with decreased thoracic cage threatens pulmonary compromise, impacts appetite, GI function, balance
  • Possible structural reinforcement prior to surgical stabilization

Patient Selection

  • Focused pain in region of fracture
  • Fracture tender to palpation
  • Absence of radicular pain
  • Subacute or acute fractures less than one year old yield greatest results (less than 4-6 months ideal); older fractures can also be treated
  • Fracture unresponsive to medical therapy (analgesics, bedrest, immobilization)
  • Fracture with activity on bone scan or edema on MRI, if in combination with other selection criteria
  • Pain from fracture negatively impacting mobility and ADLs

Contraindications:

  • Asymptomatic stable fracture
  • Clinically effective medical therapy
  • Osteomyelitis of target vertebra
  • Uncorrected coagulation disorders
  • Acute traumatic fracture of non-osteoporotic vertebra
  • Prophylaxis with no evidence of acute fracture
  • Allergy to any required component
  • Local or systemic infection

Relative Contraindications

  • Radicular pain or radiculopathy caused by a compressive syndrome unrelated to vertebral body collapse
  • Retropulsed fragment with > 20% spinal canal compromise
  • Tumor extension into epidural space
  • Severe vertebral body collapse (vertebra plana)
  • Stable fracture without pain older than one year

General Questions about the vertebroplasty procedure


What is the difference between vertebroplasty and kyphoplasty?

PVP (Percutaneous Vertebroplasty)

PVA (Percutaneous Vertebral Augmentation) **using balloon kyphoplasty

Typically performed in ASC, Inpatient, Outpatient environments Typically performed in Inpatient, Outpatient environments
Typically Mild Sedation
Typically Mild Sedation or General Anesthesia
Hospital / ASC Cost of kit: ~ $660 Hospital / ASC Cost of kit: ~$3500

Where can I find recent articles about vertebroplasty?
Recent journal articles and podium presentation abstracts can be found here.


Is there a website I can visit to learn more about vertebroplasty?

Visit www.vertebroplasty.com


How can I signup to be listed as a vertebroplasty specialist on your website?

If you have been trained in vertebroplasty and also utilize Parallax products for your procedures, you can signup at “Register with us

Coding Questions


For coding questions, please call 1-888-655-3500.

Product Information


EZflow® Cement Delivery System (CDS and IDS)

Can Parallax Cement Delivery kits be reused?
No, Parallax cement delivery systems cannot be reused or resterilized and are to be disposed of after use.

Can Parallax Cement Delivery Systems be used with any bone cement product?
The Parallax Ez-Flow® CDS is designed for the percutaneous injection of bone cement but have been optimized to work with the Parallax line of cement products.

The Parallax IDS is designed for use with a proprietary cartridge cement—it will not work with vials or other types of formats.

General bone cement questions


The Parallax bone cement set too quickly—what happened?
If the cement sets too quickly that typically means it was mixed/injected at too high a temperature or too high a humidity. The cement is intended for use at 23 C (73 F)—cooler temperatures will lengthen the setting time while higher temperatures will quicken the set time.

How should we store bone cement?
Cool, dry storage between 20° to 23° C (68° to 73° F).

Do you sell mixers for your cement line?
No. Our cement has been made easy to mix in the provided packaging without the need and extra cost of a separate mixer.

I need an MSDS for your cement products—whom should I speak with?
Please contact our customer service department for MSDS requests at 1-888-655-3500.

TRACERS® Bone Cement Opacifier

Can TRACERS be combined with any PMMA?
Absolutely. TRACERS is Barium Sulfate which is the most common bone cement opacifier on the market now in a variety of prepackaged cement formulations. TRACERS contains 5 g of Barium Sulfate which we have designed to be used with a cement containing 12 g of powder, resulting in a level of opacification of 30%. It is not recommended to add TRACERS to a cement which already contains opacification.

Are TRACERS cleared for vertebroplasty?
No

SECOUR® Acrylic Resin

Can SECOUR be combined with any opacifier?
It is recommended that Secour be used with TRACERS opacifier.

Parallax Acrylic Resin with TRACERS-Ta (Tantalum Opacifier)

Should I be concerned with using an MRI and its effect with Tantalum cement in the body?
No. Tantalum has been proved safe as an implant for years and is non-paramagnetic which means it does not react to magnets.
Please call 1-888-655-3500 for more information.

Parallax Acrylic Resin with TRACERS (Barium Sulfate Opacifier)

Can Parallax Acrylic Resin with TRACERS be used in vertebroplasty and kyphoplasty procedures?
Yes. Review the FDA clearance letter (K042947).

CLEAR-VIEW® Needles (11ga and 13ga)

Are CLEAR-VIEW Needles also Biopsy Needles?
No. CLEAR-VIEW needles are not the same as the CORE-ASSURE biopsy needles. To enable the CLEAR-VIEW needle to work with the CORE-ASSURE kit, you must order the CORE-ASSURE accessory kit and the CLEAR-VIEW 11ga needle.

CORE-ASSURE® Bone Biopsy Kits

Are these the same as CLEAR-VIEW needles?
No, you cannot use CORE-ASSURE as a replacement for CLEAR-VIEW needles. CORE-ASSURE has been designed for bone biopsy not for the percutaneous injection of bone cement. Please note that the Core-Assure accessory kits can be used with any 11 ga Clear-View bulls-eye needle which greatly helps to streamline the biopsy procedure.

Do you offer a 13ga bone biopsy needles?
No, not at this time. Due to the mechanical requirements of the biopsy procedure we feel that an 11ga cannula is required for strength and performance.