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Why Coflex®?

If non-surgical treatment options aren’t successful, it may be time to consider surgery. Decompression with the Cole Interlaminar Stabilization device is an alternative to fusion, that reduces pain, and helps preserve mobility.

The Coflex device is the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability. The “U” shape design allows the Coflex device to be positioned on the strongest bony structure of the posterior column, the lamina. The Coflex maintains the height between the bones in your spine to help the nerves move freely.

The Coflex device is an option for patients that do not want to go through pedicle screw fusion, but for whom a decompression alone would not offer needed stability.

Why Coflex®?

If non-surgical treatment options aren’t successful, it may be time to consider surgery. Decompression with the Cole Interlaminar Stabilization device is an alternative to fusion, that reduces pain, and helps preserve mobility.

The Coflex device is the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability. The “U” shape design allows the Coflex device to be positioned on the strongest bony structure of the posterior column, the lamina. The Coflex maintains the height between the bones in your spine to help the nerves move freely.

The Coflex device is an option for patients that do not want to go through pedicle screw fusion, but for whom a decompression alone would not offer needed stability.

For decades, the surgical options for patients with lumbar spinal stenosis (LSS) were limited to either decompression or decompression with spinal fusion. In 2012, the FDA approved the Coflex® Interlaminar Stabilization® device, a small U-shaped titanium implant that provides spinal stability without the invasiveness and loss of mobility associated with spinal fusion.

For decades, the surgical options for patients with lumbar spinal stenosis (LSS) were limited to either decompression or decompression with spinal fusion. In 2012, the FDA approved the Coflex® Interlaminar Stabilization® device, a small U-shaped titanium implant that provides spinal stability without the invasiveness and loss of mobility associated with spinal fusion.

Our Patients Share Their Coflex® Success Stories

Zach, a general surgeon, tells his story on how Coflex® procedure changed his life.

“I did everything I could non-operatively… non pharmacologically… stretching… physical therapy – everything that I could think of to do to improve my symptoms.”

-Zach-

To learn more about Ken’s experience, watch this
video:

“After my surgery I thought it was going to be a long process of recovery, within about 3 days I was up and walking around, within a week or so I was walking around the block a couple of times, within about 3 weeks I was able to walk without any problem whatsoever.”

-Ken-

Our Patients Share Their Coflex® Success Stories

Zach, a general surgeon, tells his story on how Coflex® procedure changed his life.

“I did everything I could non-operatively… non pharmacologically… stretching… physical therapy – everything that I could think of to do to improve my symptoms.”

-Zach-

To learn more about Ken’s experience, watch this
video:

“After my surgery I thought it was going to be a long process of recovery, within about 3 days I was up and walking around, within a week or so I was walking around the block a couple of times, within about 3 weeks I was able to walk without any problem whatsoever.”

-Ken-

Click Here To Watch More Patient Success Story Videos

Click Here To Watch More Patient Success Story Videos

In the FDA study, 94% of patients were satisfied
with their outcomes after two years.*

Ask your doctor if you’re a candidate
for the Coflex® device.

“Coflex® has become a device that can change people’s lives. It changes the length of stay for surgery, the recovery, the ability to return to activities that they weren’t able to do before in a shorter period of time.”

Andrew Fox

In the FDA study, 94% of patients were satisfied
with their outcomes after two years.*

Ask your doctor if you’re a candidate
for the Coflex® device.

“Coflex® has become a device that can change people’s lives. It changes the length of stay for surgery, the recovery, the ability to return to activities that they weren’t able to do before in a shorter period of time.”

Andrew Fox

Benefits of the Coflex® Device vs. Fusion’

Pedicle screws and rods are used to ruse bones cogether – a mighty invasive spinal stenosis surgery that can sometimes result in loss of motion and a long and arduous recovery process. In a U.S. FDA study, the can sometimes result in loss or motion and a long and arduous recovery process. In a Us, FDA study, the Coflex device proved to be a beneficial alternative to pedicle screw fusion. The results showed that patients with the Coflex device performed as well if not better in all clinical measurements The patients who received a Coflex device experienced:

  • Leg and back pain relief (both
    immediately and long-term)
  • Less time in the operating room, less blood loss, and fewer days in the hospital
  • Faster relief of symptoms and
    quicker recovery (pain and function measurements)
  • Maintenance of range of motion at both treated and  adjacent segments

What to Expect for Your Procedure

Setting expectations for your surgery ahead of time will give you peace of mind when the day of the procedure arrives. Be sure to give yourself and/or caregiver time to prepare and create a plan for after the surgery occurs.

What to Expect for Your Procedure

Setting expectations for your surgery ahead of time will give you peace of mind when the day of the procedure arrives. Be sure to give yourself and/or caregiver time to prepare and create a plan for after the surgery occurs.

Preparing for Surgery

In order to feel prepared and confident as your procedure approaches, it may be helpful to learn a little bit more about what will happen during your surgery. The Coflex procedure can be performed in an outpatient setting. You should arrange for someone to drive you, and to help during the first few hours of your recovery after surgery.

Before surgery, you might also want to ask your spine surgeon for more information such as:

  • When can I expect to be back home from surgery?
  • Is there anything else that I should do to prepare in the days leading up to surgery?
  • What can my caregiver do to help me prepare?

Preparing for Surgery

In order to feel prepared and confident as your procedure approaches, it may be helpful to learn a little bit more about what will happen during your surgery. The Coflex procedure can be performed in an outpatient setting. You should arrange for someone to drive you, and to help during the first few hours of your recovery after surgery.

Before surgery, you might also want to ask your spine surgeon for more information such as:

  • When can I expect to be back home from surgery?
  • Is there anything else that I should do to prepare in the days leading up to surgery?
  • What can my caregiver do to help me prepare?

The Surgical Procedure

Decompression surgery involves removing the pressure on the nerves that causes pain. After undergoing decompression surgery, the Coflex device will be inserted through the incision made for the decompression. The Coflex device is positioned on your lamina, which is the strongest bone in the back of your spine. On average, the entire procedure, including decompression and the implantation of the Coflex device, takes approximately 100 minutes.

Recovery

Most patients are under general anesthesia, so a short recovery period is necessary following the procedure.

Immediately following surgery

When you wake from recovery, you may be encouraged to get up and walk almost immediately, taking into consideration your overall health at the time of surgery. Since there is no fusion, and therefore no healing bone to wait for, you’ll most likely be able to do this right after your procedure. You’ll notice that your pain has been significantly relieved, and your spine should feel stable and strong. Most patients do need to wait several days following the surgery for the incision wound to heal.’

Weeks and months following surgery

In the weeks and months following surgery, your recovery depends on a number of factors, including the degree of your stenosis and the extent of the decompression that was performed. Most patients are able to return to normal activity, and even expanded activity such as golf, cycling, or gardening, within weeks of the surgery. Some patients may require physical therapy to help with mobility and flexibility.’

The Surgical Procedure

Decompression surgery involves removing the pressure on the nerves that causes pain. After undergoing decompression surgery, the Coflex device will be inserted through the incision made for the decompression. The Coflex device is positioned on your lamina, which is the strongest bone in the back of your spine. On average, the entire procedure, including decompression and the implantation of the Coflex device, takes approximately 100 minutes.

Recovery

Most patients are under general anesthesia, so a short recovery period is necessary following the procedure.

Immediately following surgery

When you wake from recovery, you may be encouraged to get up and walk almost immediately, taking into consideration your overall health at the time of surgery. Since there is no fusion, and therefore no healing bone to wait for, you’ll most likely be able to do this right after your procedure. You’ll notice that your pain has been significantly relieved, and your spine should feel stable and strong. Most patients do need to wait several days following the surgery for the incision wound to heal.’

Weeks and months following surgery

In the weeks and months following surgery, your recovery depends on a number of factors, including the degree of your stenosis and the extent of the decompression that was performed. Most patients are able to return to normal activity, and even expanded activity such as golf, cycling, or gardening, within weeks of the surgery. Some patients may require physical therapy to help with mobility and flexibility.’

Caring for Someone Receiving Surgery

If you are a caregiver for a person receiving the Coflex® device, it is important to know how to best support them throughout the process. Here are some ways you can ensure their surgery preparation and recovery go smoothly:

  • Be aware of their post-surgery recovery requirements
  • Provide encouragement and emotonal support
  • Remind them to take their medications
  • Point our any propress you nouce to keep them motivated

1 Every patient is different; therefore results may vary. Your spine surgeon will advise you on a particular level of post-
surgical activity that is right for you.

Caring for Someone Receiving Surgery

If you are a caregiver for a person receiving the Coflex® device, it is important to know how to best support them throughout the process. Here are some ways you can ensure their surgery preparation and recovery go smoothly:

  • Be aware of their post-surgery recovery requirements
  • Provide encouragement and emotonal support
  • Remind them to take their medications
  • Point our any propress you nouce to keep them motivated

1 Every patient is different; therefore results may vary. Your spine surgeon will advise you on a particular level of post-
surgical activity that is right for you.

The Coflex® device is the FIRST AND ONLY posterior lumbar motion preservation solution with Level I evidence (the highest possible level of clinical data) from two prospective randomized studies against two treatment options.’ There are many peer-reviewed publications on the Coflex® device, making it one of the most studied lumbar spinal devices on the market. The Coflex® device has been implanted in more than 175,000 patients in over 60 countries.

This makes the Coflex® device the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability.

The Coflex® device is the FIRST AND ONLY posterior lumbar motion preservation solution with Level I evidence (the highest possible level of clinical data) from two prospective randomized studies against two treatment options.’ There are many peer-reviewed publications on the Coflex® device, making it one of the most studied lumbar spinal devices on the market. The Coflex® device has been implanted in more than 175,000 patients in over 60 countries.

This makes the Coflex® device the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability.

90% Coflex® vs 77% spinal fusion?

  • At six weeks, Coflex® patients experienced Quicker relier of their symotoms when compared to soina rusion patients

94% Coflex@ vs 87% spinal fusion?

  • At two years, Coflex® patients had longer
    lasting relief of their symptoms compared to spinal fusion.

94% Coflex® vs 87% spinal fusion?

  • At five years, Coflex® patients were happier with their outcomes when compared to patients that underwent spinal fusion

To ensure that you have all the information you or your loved ones need, below are the questions most asked by patients who’ve used the Coflex® Interlaminar Stabilization® device:

Will I need physical therapy following surgery?2023-09-13T09:52:17+00:00

In some cases, your doctor may prescribe physical therapy to help you get back to an activity and mobility level that you can be comfortable with.

During the clinical study, walking during the first six weeks following surgery was usually acceptable. Additionally, patients were allowed to travel and engage in light activity such as walking as soon as they felt they could.1

It’s important to remember that you have had a surgical operation. Always follow your spine surgeon’s instructions on how much activity you can undertake and for how long.

“Evaluation of decompression and Interlaminar Stabilization compared with decompression and fusion for the treatment of lumbar spinal stenosis: 5-year follow-up of a prospective, randomized, controlled trial.” Musacchio, M., International Journal of Spine Surgery, 2016.

Will I need pain medication following the surgery?2023-09-13T09:51:45+00:00

In some cases, patients have reported using pain medication to deal with post-surgery symptoms.

How long will I have to stay in the hospital or at the surgery center?2023-09-13T09:51:00+00:00

In a U.S. FDA clinical study, patients left the hospital on average in less than two days.1 In some cases, the spine specialist may elect to perform the procedure in a surgery center, which means that those patients will not require a hospital stay.

¹ Every patient is different; therefore, results may vary.

What will the pain in my legs and back be like following the surgery?2023-09-13T09:50:13+00:00

In almost all cases, your pain will be significantly relieved, because the cause of the stenosis will have been surgically remedied. Some patients do experience some pain at the site of the incision, but this usually subsides considerably in the days and weeks following surgery.

How soon can I resume normal activity following surgery?2023-09-13T09:49:24+00:00

Your level of post-surgical physical activity may vary depending on the extent of your decompression. Your spine surgeon will likely ask you to come in for a follow-up visit approximately six weeks after your procedure. During those six weeks, the spine surgeon may ask you to limit your physical activity, based on various factors.

Can I have an MRI after getting the Coflex® implant?2023-09-13T09:48:29+00:00

Non-clinical testing has shown that the Coflex® Interlaminar Stabilization® device is MR conditional and can be scanned safely under the following conditions:
Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T)
Spatial gradient field of up to:
11,230 G/cm (112.3T/m) for 1.5T systems
5,610 G/cm (56.1T/m) for 3.0T systems
Maximum whole body averaged specific absorption rate (SAR) of:
0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5T
0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0T
To learn more about MRI compatibility, review our full list of specifications. (downloadable PDF link)

Will my Coflex® implant set off metal detectors?2023-09-13T09:47:57+00:00

The metal that makes up the Coflex® device may affect MR imaging and metal detectors. You should alert any technicians that you have a titanium device implanted in your spine. You should also consider making this declaration if you’re traveling and have to pass through an electronic detection system.

If I need surgery, what can I expect during the recovery process?2023-09-13T09:47:25+00:00

Setting expectations for recovery up front is essential before going into any surgical procedure. Communicate with your doctor about creating an after-surgery plan.

How effective is the Coflex® device?2023-09-13T09:46:38+00:00

There are many peer-reviewed publications on the Coflex® device, making it one of the most studied lumbar spinal devices on the market. Learn more

What are the potential long-term effects of surgery for LSS?2023-09-13T09:46:04+00:00

If you choose to undergo surgery, it’s important to know up front what effects it may have over time. For example, spinal fusion may limit back mobility and flexibility while decompression alone may cause your spine to lose its strength.

Do I need lumbar spinal stenosis surgery?2023-09-13T09:45:15+00:00

Depending on the severity of your LSS, you may be able to successfully treat it without surgery. For more severe cases, there are several surgical options. Talk to your doctor about the best treatment for you.

Which treatment option is right for me?2023-09-13T09:44:29+00:00

Every treatment is different, and what’s right for you will vary depending on the severity of your LSS, how active your lifestyle is or what symptoms you experience most. It’s important to understand your treatment plan, and how it will fit into your life in the long term. Some examples of conservative care that may be recommended for you include physical therapy, acupuncture, or getting the proper exercise. If your LSS is more severe, you may require a surgical procedure.

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