One of the benefits of a drug delivery system is the ability to use a screening test and determine if this therapy will be beneficial for you and help manage your specific type of pain. A screening test will also help your physician see what dosages of pain medication may work the best for you.

There are several methods that may be used for the screening test, but the goal will be to simulate how the drug delivery system might work if it were implanted. You will normally go to a hospital or surgery center for your test.

Injection Test
With this test, you will have specialized pain medicine injected into your back near the spinal cord, simulating how the drug delivery will work. Your physician will then monitor your pain sensations and note how well your pain levels respond to the medication and at what dosage.

Infusion Test
With this test, your physician will insert a tiny, narrow tube called a catheter into your back and attach it to a small pump. This simulates the continuous flow of medication that the pump is able to deliver once implanted, and your physician will be able to monitor your pain levels and how you respond to the medication.

When discussing and planning the procedure with your doctor, be sure to confirm your insurance coverage of the procedure and any required hospital stay well in advance.

Tell your doctor about the medications you’re taking, about your allergies, and about any surgeries you have had, as well as any reactions to anesthesia in the past.

Arrange to have someone accompany you to the hospital on the day of the procedure, and to have someone drive you home afterward. You may also need to have a friend or family member help you at home for a day or two after the surgery.

Before your surgery, your doctor will determine the most suitable spot in your abdomen for the pump in an effort to not interfere with clothing or daily activities.

Your doctor and the hospital will give you important instructions to follow before the surgery. Follow these pre-surgery instructions carefully.

In most cases:

• You will need to stop eating and drinking at some point before the surgery.
• Your physician will tell you which medications you can and cannot take before the procedure.
• You will need to shower or bathe before going to the hospital, and avoid using lotions, powders or perfumes.

On the day of the procedure:

• Have someone go with you to the hospital.
• Wear simple, loose-fitting clothing and shoes that are easy to slip on and off.

If your trial is successful, will be implanted with a drug delivery pump during a surgical procedure that usually lasts one to three hours and will take place at a hospital or surgical center.

You will be comfortably sedated and monitored by an anesthesiologist during the surgery. The physician will make an incision in the skin of your abdomen to place the pump. Then, a second incision will be made in your back to allow the catheter to be placed near the spinal cord. Then, the other end of the catheter will be threaded under your skin and connected to the pump in your abdomen, making the entire system internal and fully implanted. There are no components on the outside of the body. Once the system has been tested and checked, the incisions are closed and the surgery is completed.

As with any surgery, there may be risks including infection and spinal fluid leak. A so-called “spinal headache” is also possible. After the system is implanted, problems with the device may occur and require additional surgery. Improper functioning of the device can result in drug overdose or underdose that may have serious or life-threatening adverse effects. Possible complications with the device can include the catheter or pump moving within the body or wearing through the skin. The catheter could leak, tear, kink or become disconnected. The pump could stop if the battery runs out or because some other element of the system has failed. Additionally, inflammatory masses have been reported at the tip of the catheter, which may lead to complications.

• Improved ability to function and participate in day-to-day activities
• Effective pain relief
• Less or no need for oral pain medication
• Fewer side effects compared to oral medication
• A remote that allows you to manage your own pain therapy by delivering a dose of medication within your doctor’s pre-set limits.
• Surgically reversible

Additionally:

• Because targeted drug delivery releases small amounts of medication directly to the fluid surrounding your spine, pain can be controlled with a fraction of the oral medication dose.
• Most people experience fewer or more tolerable side effects versus oral dosing, such as constipation and drowsiness.
• Targeted drug delivery may provide relief when other treatments — like oral medications or injections — have not
• It does not have to be a permanent procedure like back surgery.
• The trial serves as a temporary evaluation period before committing to long-term therapy.

Please View Important Safety Information on the Flowonix website here.