What Is The Definition Of Chronic Pain?

Physicians generally define chronic pain as pain that is present for six months or longer and is not relieved by standard medical management. Chronic pain can result from an injury or trauma, such as a fall or an on-the-job injury, or it can result from a disease or dysfunction of the central or peripheral nervous system. Chronic pain that has not been relieved by ordinary medical, surgical or nursing measures is known as chronic intractable pain. Chronic intractable pain affects personal lives, healthcare resources and the economy.

How Many People In The U.S. Suffer From Chronic Pain?

Chronic pain is one of the world’s most pressing health care issues. In the U.S. alone, nearly 100 million people suffer from chronic pain, and over half of these chronic pain sufferers are partially or totally disabled. Although Americans now spend more than $100 billion annually in combined direct and indirect costs to manage chronic pain, many chronic pain sufferers do not receive adequate treatment or pain relief.

For Those Suffering From Chronic Pain, What Treatment Options Are Available?

Physicians have many traditional and innovative treatment options for chronic pain sufferers, and they generally treat chronic pain through a progression of therapies. These therapies range from the most conservative treatment measures, which are employed first, to the most advanced and sometimes invasive, which are employed as pain continues to resist treatment. The first line of treatment can include over-the-counter pain medications, exercise programs, physical therapy, nerve blocks and behavior modification. When these therapies fail to provide sufficient pain relief, physicians move to more aggressive therapies such as surgery and narcotics. When these more aggressive therapies fail, physicians then prescribe advanced therapies. These advanced therapies can include neuroablation (an irreversible surgical technique that permanently blocks nerve pathways to the brain by destroying nerves and tissues at the source of the pain) and neuromodulation -- the delivery of electric current (neurostimulation) or drugs (intrathecal drug delivery systems) directly to targeted nerve fibers.

What Is Neuromodulation?

Neuromodulation is a relatively new discipline of medicine encompassing several specialties including neurosurgery, anesthesiology, orthopedics, neurology and neurophysiology. Neuromodulation includes implantable therapies for the treatment of chronic pain and other disorders of the central nervous system. These therapies include implantable drug pumps* that deliver small doses of drugs directly to nerve fibers and spinal cord stimulators that deliver small doses of electricity directly to nerve fibers. This direct approach to targeting neurological problems at their source can be very effective in modulating or lessening pain symptoms. Until recently, treatments for chronic pain and other central nervous system disorders have been limited to systemic drugs or surgery -- treatments with often undesirable or irreversible effects.

What Is Spinal Cord Stimulation And How Does It Work?

Spinal cord stimulation (SCS) is an FDA-cleared therapy indicated for the treatment of chronic pain of the trunk and/or limbs. SCS systems are implantable devices that resemble pacemakers in appearance and function (you can think of them as pain pacemakers). The systems work by generating electrical pulses that interfere with the transmission of pain signals to the brain. These electrical pulses replace painful sensations with a gentle tingling sensation called paresthesia.

Spinal cord stimulators typically consist of three components designed to work together as a system: an implanted power source or receiver, an implanted lead (or leads) with electrodes and an external controller. A relatively short noninvasive surgical procedure is required to place the lead or leads in the space above the spinal column (epidural space) and to implant the power source or receiver. After the leads and power source/receiver are implanted, the physician uses the external controller to program the power source and to customize the electrical pulses for the individual receiving the therapy. The patient also can use the controller to change certain settings determined by his or her physician.

Who Can Benefit From Spinal Cord Stimulation?

Spinal cord stimulation works best for patients with chronic or neuropathic pain -- pain as a result of dysfunction or damage to the nervous system through injury, disease or localized trauma (e.g., an infection or surgery).

Spinal cord stimulation is not a treatment option for everyone. A number of factors affect whether a patient is a good candidate for SCS. These include the patient’s diagnosis and medical history, as well as the severity, location and type of pain. Generally, a trial procedure is performed to determine a patient’s response to SCS before a permanent system is implanted.

What Are The Advantages Of Spinal Cord Stimulation Over Other Pain Management Options?

Spinal cord stimulation can be effective in treating chronic pain of the trunk and/or limbs and other nervous system disorders. Unlike many other options, SCS has the advantage of being reversible if the desired outcome is not achieved. Another advantage is that an SCS trial allows physicians and patients the opportunity to see if the therapy will be effective before a permanent system is implanted.

What Is The Difference Between An Implantable Pulse Generator (Ipg) And A Radio Frequency (Rf) System?

While both IPG and RF systems require similar leads, implantation techniques and trial processes, the IPG and RF systems require different power sources.

An IPG’s power source consists of a battery and related electronics housed in a single metal container. A major advantage of the IPG is that it is totally implanted under the skin; therefore, it is more discreet, making it possible to bathe, shower or swim while receiving stimulation. The key disadvantage is an IPG has a fixed battery life. When the battery runs out, the IPG must be replaced surgically. Thus, an IPG is best suited for simple pain patterns, which require less energy than complex pain patterns.

An RF system’s power source, on the other hand, is a rechargeable battery located outside the body in a small controller called a transmitter. The transmitter uses radio-frequency energy to send signals though an external antenna to a passive receiver implanted under the patient’s skin. The receiver converts the radio-frequency signals into electrical energy. The receiver also interprets data and delivers sets of electrical impulses, based on the number of programs prescribed by the physician, through one or more implanted leads. Because the battery is easily changed or recharged, an RF system is better suited for patients with complex pain patterns, which require more energy and advanced programming than simple pain patterns.

What Are The Features And Capabilities Of Ans’ Genesis And Genesisxp Implantable Pulse Generators?

With the breakthrough technology of Genesis and GenesisXP, ANS is advancing the treatment of chronic pain. ANS’ Genesis family of products is designed to be easy to implant, simple to program and highly flexible, providing patients with more programming options and control than any IPG currently on the market.

Genesis And GenesisXP Features

• An extended battery capacity exceeding that of traditional IPGs
• Versatile leads that can be configured to meet the full range of clinical and patient needs
• Optimum electrode size and spacing ensure precise stimulation and optimal coverage
• An easy-to-use patient interface with simple, convenient visual and audio control
• Up to 24 customized MultiStim (multiple stimulation) programs for greater control and coverage
• PC-Stim (patient-controlled stimulation) enables patients to select from multiple prescribed programs for greater control
• Constant current stimulation that provides patients consistent and reliable stimulation

What Are The Features And Capabilities Of Ans’ Renew Radio-Frequency Systems?

How Does The Ans Trial System Work?

Who Are Ans’ Customers?

ANS designs, develops, manufactures and markets implantable medical devices used to manage chronic intractable pain and other disorders of the nervous system though neuromodulation. ANS customers include neurosurgeons, orthopedic surgeons, anesthesiologists and other interventional pain physicians whose patients can benefit from neuromodulation therapy.

What Is The Company’s Current Market Position?

The neuromodulation market has been growing at a rate of 20 to 25 percent annually and is expected to increase from $700 million in 2002 to over $1 billion by 2005. ANS has uniquely positioned itself to take a leadership role in this large and growing market.

ANS, already a technology leader with 50 percent market share in the RF-SCS segment, recently entered the much larger IPG-SCS market. In 2002, ANS introduced the Genesis and GenesisXP IPGs, which are the most advanced SCS systems in the world. With the introduction of its Genesis IPG-SCS systems, ANS is now one of only two companies able to participate in this growing $232 million market segment.

What Is The Future Direction Of ANS**?

ANS has positioned itself to expand its participation from the SCS market into many other current and emerging segments, such as deep brain stimulation and implantable drug pumps. Its strategy is to strengthen its implantable neurostimulation and drug pump technology platforms and to use these platforms to develop products that address significant clinical needs.