Marketing: FAQs by Patients Flashcards

1
Q

What are the potential benefits of the mild® Procedure?

A

mild® may help patients diagnosed with lumbar spinal stenosis (LSS) stand longer and walk farther with less pain by treating the underlying cause of LSS symptoms in a minimally invasive way.

Outpatient procedure, typically performed in less than 1 hour

Patients typically resume normal activity within 24 hours with no restrictions

Requires no general anesthesia, implants, stitches, steroids or opioids

Low complication risk profile and high efficacy profile as demonstrated in clinical studies

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2
Q

Does the mild® Procedure require general anesthesia?

A

No, the mild® Procedure is performed in an outpatient setting and does not require general anesthesia. The mild® Procedure is generally performed with only local anesthetic and light sedation.

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3
Q

How long does the mild® Procedure take?

A

mild® is a short outpatient procedure that is typically performed in less than one hour. Most patients return home the same day and typically resume normal activity within 24 hours with no restrictions.

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4
Q

Is mild® accepted by my insurance?

A

The mild® Procedure is covered nationwide by Medicare (all ages, all plan types, including Medicare Advantage) the VA, U.S. Military & IHS. Commercial coverage varies. Talk to your doctor to obtain coverage specifics for your plan type.

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5
Q

What are the side effects of the procedure?

A

The mild® Procedure has a strong safety profile and has been performed on thousands of patients. Individual results may vary.

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6
Q

What is the recovery time like?

A

Following the mild® Procedure, most patients return home the same day and typically resume normal activity within 24 hours with no restrictions

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7
Q

Is mild® cleared by the FDA?

A

Yes, the mild® Device kit was cleared by the U.S. Food and Drug Administration for lumbar decompressive procedures.

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8
Q

Where can I find a mild® doctor near me?

A

Thank you for your interest in the mild® Procedure. You can find a list of mild® trained doctors on our Find a Doctor page.

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9
Q

Is mild® offered outside of the United States?

A

Our long-term vision is to create global patient access to the mild® therapy. We are actively planning for international expansion, but are not yet ready to initiate our efforts.

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10
Q

How is lumbar spinal stenosis (LSS) diagnosed?

A

When diagnosing lumbar spinal stenosis (LSS), a medical history that lists your symptoms will be reviewed. Symptoms may include pain or numbness in the lower back when standing upright; pain, numbness, heaviness or tingling in upper legs and buttocks when walking; pain when lying down that may be relieved by curling into fetal position and temporary relief when bending forward. Other tests, including a physical examination to assess mobility, may also be performed as well as imaging, such as x-rays, an MRI or a CT scan.

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11
Q

Can I be born with spinal stenosis and/or is spinal stenosis hereditary?

A

Lumbar spinal stenosis (LSS) is a common age-related disease with over two million patients nationwide diagnosed and treated annually.3 As Cleveland Clinic states, “Spinal stenosis usually develops slowly over time. It is most commonly caused by osteoarthritis or ‘wear-and-tear’ changes that naturally occur in your spine as you age.” However, LSS can be related to a condition that is congenital, or present from birth, and in some cases hereditary.8 For example, those born with a narrow spinal canal (congenital stenosis), curved spine (scoliosis) and/or a genetic disease affecting bone and muscle development throughout the body may be at risk for spinal stenosis.

While most people with spinal stenosis are over the age of 50 and the chances of it progress with age, onset of the condition may occur earlier in life. Around 4% of the population under the age of 40 years old acquires LSS.

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12
Q

What are the long-term effects of lumbar spinal stenosis (LSS)?

A

Lumbar spinal stenosis (LSS) may cause pain, a pinched nerve (radiculopathy), or symptoms of pain, numbness, heaviness or tingling in the upper legs or buttocks while walking, also known as neurogenic claudication. Mayo Clinic states that in rare instances, untreated severe spinal stenosis may progress and cause permanent numbness, weakness, balance problems, incontinence and paralysis. While untreated LSS does not usually cause paralysis, Cleveland Clinic explains that, “if a spinal nerve or spinal cord is compressed for a long period of time, permanent numbness and/or paralysis is possible.” If any of the above symptoms are present (numbness, weakness, balance problems, incontinence and paralysis), it’s important to seek medical attention right away.

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13
Q

What activities should be avoided with lumbar spinal stenosis (LSS)?

A

Common lumbar spinal stenosis (LSS) symptoms can include pain, numbness, heaviness or tingling when walking or standing. Relief may also be found when sitting or bending forward as pressure on the spinal cord is released and space in the spinal canal is “opened.” If these symptoms are familiar, it’s encouraged to schedule an appointment with a doctor, instead of avoiding exercises and activities that spur pain or adhering to a sedentary lifestyle. One common misconception is that back pain is a part of aging that cannot be avoided or treated. However, there are specialized interventional pain physicians trained to help patients who are experiencing chronic pain, like lumbar spinal stenosis, find long-term relief and help them safely manage their symptoms.

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14
Q

What does minimally invasive lumbar decompression mean?

A

Minimally invasive lumbar decompression, commonly referred to as the mild® Procedure, is an outpatient procedure that relieves pressure on the spine. Like a water hose that has pressure on it or a drinking straw with a kink in it, the spinal canal can narrow and compress the spinal canal nerves in the lower back. To restore space in the spinal canal and reduce the compression of the nerves—or in the case of the water hose and drinking straw, increase the flow—a mild® Doctor uses an imaging machine and specialized tools to remove small pieces of bone and thickened ligament.

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15
Q

How is mild® different from traditional back surgery?

A

The mild® Procedure is different from traditional back surgery because it is an outpatient procedure that does not require general anesthesia, implants, stitches, steroids or opioids. Typically completed in less than an hour, mild® can be performed through a single, tiny incision smaller than the size of a baby aspirin (5.1 mm) using only local anesthetic and light sedation and leaves no implants behind. With a safety profile similar to an epidural steroid injection (ESI), but with lasting results, mild® addresses a major root cause of lumbar spinal stenosis (LSS) and can be performed as a steroid-free procedure, which limits immunosuppression risks associated with ESIs.18

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