Artiste® Assisted Injection System

Artiste® FAQ's

Frequently asked questions regarding the Artiste Assisted Injection System.

Is Artiste FDA approved?

Artiste is not subject to "approval" by FDA via the premarket approval process (PMA). Rather, it is subject to a process known as "510(k) clearance," whereby FDA "clears," rather than "approves," the product. We received 510(k) clearance for Artiste with the following indication: "The device is a syringe assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician."

What kind of materials can you inject with it?

The Artiste system has an indication as an assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician.

Does it have a CE Mark?

Yes, the Artiste System is available for sale in the EU with a CE Mark and is currently marketed in the UK through EFD International. For additional information contact EFD International at +44 (0) 1582 691905.

How long has this device been available?

The device was launched in the UK and select US cities in May of 2011. For additional information and sales availability please contact Nordson MICROMEDICS at 800-624-5662.

Is it available for sale now?

As this is a new technology that requires changing the standard practice of injecting sterile materials, the sales process is very hands on to ensure the clinicians have proper training with the system. We are currently selling into markets that are serviced by our sales staff in MN, CA, NY and the UK. As we expand our sales force we will address additional geographies.

Can anyone buy it?

No. This is a medical device only available for sale on order of a physician or properly licensed practitioner. If you would like additional information as to whether you are eligible to purchase Artiste, please contact Nordson MICROMEDICS Customer Service at 800-624-5662.

Are you currently doing any studies?

We are currently conducting a Randomized, Evaluator-Blind, Bilateral Comparison of an Injection Assistance Device Vs Manual Injections for Delivery of Dermal Fillers in Patients Seeking Aesthetic Correction of the Nasolabial Folds Study. Enrollment began in December and we anticipate the initial results in Feb/March 2012.

What is the price of the system?

For specifics on pricing and availability please contact Nordson MICROMEDICS.

Where is Artiste made?

The Artiste Injection System is made in the USA by Nordson MICROMEDICS, St Paul, MN.

What kind of training does Nordson offer?

To ensure the system is seamlessly integrated into the office setting, our sales rep will come on site to train the entire office staff. Once training is completed, a training certificate is provided. We provide additional assistance as needed, but have found there is a quick learning curve.

How does the system compare to a manual syringe?

Artiste was developed within guidelines to maintain pressures similar to those delivered by a manual syringe, but provides an automated pressure source resulting in consistent delivery. The Artiste System was designed to perform in a more uniform manner with less overall pressure, allowing greater control than in a non-assisted approach.

Is there a sales rep in my area to give me a demo?

Please contact Nordson MICROMEDICS Customer Service at 800-624-5662 to be connected with your local representative.

I operate a day spa – can I buy one?

This is a medical device and only available for sale on order of a physician or properly licensed practitioner. For further information on evaluation and purchase of Artiste please contact us at 800-624-5662.

Do you need any special training to use it?

To ensure the system is seamlessly integrated into the office setting, our sales rep will come on site to train the entire office staff. Once training is completed, a training certificate is provided. We provide additional assistance as needed, but have found there is a quick learning curve.

Is there any downside to using this device vs manual injection?

The system simply provides an alternate way to do injections and is designed for more consistent, repeatable delivery with less hand fatigue. Our feedback has shown this system easily integrates into the clinical setting.

Why would I use this versus manual injection?

The Artiste System automates the injection process and offers:

  • Ergonomic design for improved syringe handling
  • Less hand fatigue
  • Increased injection control for more consistent material delivery
  • Compact CO2 power source for consistent, repeatable injections
  • Adjustable flow to accommodate a variety of materials and injection techniques

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