BBI Contributing Writer

SAN DIEGO, California The 18th annual meeting of the North American Spine Society (NASS; LaGrange, Illinois) was held here last fall, with more than 5,000 in attendance, including 3,000 physicians and over 2,000 healthcare professionals and company attendees. NASS is a multidisciplinary organization that advances spine care through education, research and advocacy, with more than 3,500 members from all over the world.

Spinal surgery is one of the fastest-growing segments of the $17 billion worldwide orthopedics sector. This past year was an exceptional one for the spine industry. Spine Solutions (Paoli, Pennsylvania) a development-stage company, sold to Synthes (West Chester, Pennsylvania) for $350 million; Link Spine Group (Branford, Connecticut) sold to DePuy Spine (Raynham, Massachusetts) for $325 million and Spinal Concepts (Austin, Texas) sold to Abbott Laboratories (Abbott Park, Illinois) for $210 million.

In addition, Medtronic's (Minneapolis, Minnesota) InFUSE bone growth stimulator is now a $100 million-plus business and with the $4,450 new technology add-on payment, will continue to increase. Vertebroplasty/kyphoplasty, with Kyphon (Sunnyvale, California) leading the way, also should cross the $100 million mark this year. Low back pain affects four out of five Americans at some point in their lives. In 2002, sales of spinal implants and instrumentation approached $2.4 billion, up 26% as outlined in Table 4.

This market devices to treat conditions of the spine is expected to double in the next five years, driven by technology in devices, biologics and demographics. Spinal fusion and implants are used to restore stability to the spine, correct deformity and bridge spaces created by the removal of damaged spinal elements such as discs. The market includes about 1 million surgical procedures per year, including laminectomies, micro-discectomies, spinal fusions and spinal fixation. The desire of healthcare payers is for more cost-effective therapies requiring shorter hospitalization stays. The desire of patients is for less invasive and less painful procedures with decreased potential for complications. These surgical improvements should lead to a rapid recuperation and an increased quality of life.

As shown in Table 5, more than 150,000 lumbar and nearly 200,000 cervical spinal fusions are performed each year to treat common spinal conditions such as degenerative disc disease and spondylolisthesis, or misaligned vertebrae. Some 28% of spinal fusions are multi-level, meaning that more than two vertebrae are fused. Such fusions "weld" unstable vertebrae together to eliminate pain caused by their movement and degeneration of the disk. In addition, fusion can be driven by vertebral fracture or deformity. The surgical approach may be anterior (i.e., from the abdominal cavity), posterior (i.e. directly from the back to the spine) or a combination of both. To ensure position and rigid alignment while fusion takes place, surgeons apply spinal instruments, or implants, such as screws and rods to the spine. These implants are joined together to maintain spinal stability and are rarely removed. Instrumentation used to stabilize the fusion includes pedicle or facet screws, rods and hooks, with a combined average sales price per case of approximately $5,000, in addition to cages and plating systems. Table 6 outlines the numbers of spinal fusions that are performed with instrumentation.

Of the 1 million total annual spinal operative procedures performed in the U.S., only 16,000 (1.6%) were catheter-based procedures with related device sales of $21 million. These figures reveal the early stages of the impending explosion of minimally-invasive/catheter-based techniques into the operative orthopedic spine market. It is estimated that by 2005, the number of spinal catheter-based procedures will grow to 82,000, or 6.5% of a forecasted total of 1.255 million spinal operations, with related device sales exceeding $101 million.

Reimbursement for spinal procedures improves

One of the additional factors contributing to the continued growth of spinal fusion procedures is improved reimbursement for the procedure. Some of the biggest increases were for DRG 497 and 498 (spinal fusion with and without complications and/ or comorbid conditions), which increased 7.6% and 10.1% respectively for 2003. It also is possible for a new technology to receive additional payment if, after two to three years of data are collected, and the charges are significantly (>50%) higher than anything else in the diagnosis-related group (DRG) category to which it is assigned. The technology must present a "substantial improvement in caring for Medicare beneficiaries" and the technology must be new; that is, cost data on the procedure must not currently be available in Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) data.

In 2002, Medtronic attempted to show that its bone growth stimulator used in spinal fusion, InFUSE, exceeded the average Medicare charges needed for threshold payment. However, it was turned down for "lack of data." It returned last year with data it had collected from 31 claims at four hospitals on the bone growth stimulator showing that the typical user of InFUSE uses two doses at an average $17,000 charge for both doses (including the cage, collagen sponge and two 1.5 mg/ml doses of rhBMP-2). CMS agreed that InFUSE does indeed meet the threshold requirement, however, after several official reports were released stating that the agency would pay the "first-ever new technology add-on payment for a medical device" in the amount of $8,900, a corrected report was released at the 11th hour (Oct. 3, 2003, Federal Register), cutting that amount in half to $4,450. That action was based on 50% of average cost of a single (rather than two) doses of the BMP. In addition, specific wording was included to "limit payment to only InFUSE technology," thus requiring follow-on BMP manufacturers to collect several years of data before they might also be eligible for the add-on payment. DRG reimbursement for single-level fusion is between $37,200 and $41,321, and the $4,450 is an additional payment, as shown in Table 7.

CMS estimates that with this supplemental approval, Medicare will be making payments for 500 cases (out of a total of 300,000 single-level spinal fusions in 2004) and paying out $2.2 million annually. Since Medicare often sets standards by which other insurers in the U.S. establish reimbursement, other payers also may agree to reimburse more for use of InFUSE, further positively influencing adoption.

Fluoroscope guides spine navigation

Although there has recently been much work directed toward developing minimally invasive spinal surgical techniques, these techniques have relied largely upon endoscopic guidance, which generally requires somewhat large access pathways through the tissues between the vertebrae and gives only an indirect or peripheral navigational view of spinous structures. In spite of their exposure to radiation, and requirements of interpretation, X-ray images or fluoroscopic guidance give a direct and immediate assessment of device location within bony structures, intervertebral discs and paraspinous musculature. Fluoroscopic guidance does not require additional large percutaneous access sheaths to be placed for introduction of the imaging system. Already many spinal procedures, such as pain management spinal injections as well as vertebroplasty and kyphoplasty, and the newer minimally invasive spinal fixation procedures, are fluoroscopically guided. High-quality fluoroscopic imaging units already are available in most community hospitals and all major medical centers. Advances in rapid computed tomography (CT) and magnetic resonance (MR) imaging (possibly in combination with standard fluoroscopic imaging) will further improve real-time radiological imaging and navigation of the spine and its associated structures.

Hybrid units such as the Iso-C 3-D Fluoroscope from Siemens AG (Munich, Germany) provide surgeons the ability to obtain standard 2-D radiographic images in addition to providing low-resolution 3-D intraoperative CT scans. Larry Khoo, MD, co-director, of the UCLA Comprehensive Spine Center (Los Angeles, California) and assistant professor of neurosurgical and orthopedic surgery, said, "Such systems allow us to check the adequacy of the decompression, the final alignment of the spine and the position of the instrumentation before leaving the operating theater. This is not only good for the patient, but is also a cost-saving measure to prevent unnecessary additional surgery." Khoo discusses transitions in minimally invasive spinal procedures in his forthcoming book, An Anatomical Approach to Minimal Access Surgery, from Quality Medical Publishing (St. Louis, Missouri).

There are 700,000 vertebral compression fractures caused by osteoporosis in the U.S. each year, with about 270,000 diagnosed, growing at about 3% a year. Of all the fractures that occur in the body, up to 50% occur in the spine. Approximately 150,000 hospitalizations per year are for the medical management of vertebral compression fractures, many using one of the minimally invasive technologies designed to repair the fractures. Kyphon markets a balloon that is percutaneously inserted into the vertebrae and expands to reduce vertebral body compression fractures. Public since May 2002, Kyphon initiated sales in 1999 and commenced full commercial U.S. introduction in 2000. As of September 2003, it had 409 employees. Kyphon's 2002 domestic revenues totaled about $70 million, and the company was expected to hit more than $110 million in 2003. The company's intellectual property includes 23 patents covering balloons in bone in any part of the body. Table 8 compares Kyphon to alternative vertebral fracture repair technologies.

The KyphX Xpander Inflatable Bone Tamp is a balloon and, similar to an angioplasty balloon, can be viewed under image guidance during surgery. The force of balloon inflation compacts cancellous bone and pushes the cortical bone apart. If the bone being treated is partially healed or has an uninjured area, this area can resist balloon expansion. The pressure the bone exerts on the balloon, reflecting its resistance to volume expansion, can be measured on the pressure gauge of the KyphX Xpander Inflation Syringe. Physicians are trained on using Kyphon's instruments during a one-day course, with didactics in the morning followed by a cadaver lab in the afternoon and supported with on-site assistance for the first five to 10 cases. The single-use kit for one vertebrae costs $3,453, and a second vertebrae an additional $2,000.

Kyphon's instruments provide an alternative to pain management therapies. The company has a direct sales force in the U.S. and a combination of direct representatives and third-party distributors internationally.

New era for minimally invasive spine fusion

Medical treatments for spinal injury, deformity or the degenerative process of aging include a combination of medication, physical therapy, bracing or lifestyle changes and for some, surgery. The most beneficial aspect of traditional open surgery is the ability for the physician to have direct access to the spine and full view of the operative field. However, due to the large incisions and significant damage to the muscle, open-surgery patients may experience hospital stays, recovery periods, scarring and pain that make this type of surgery daunting. Developing procedures that significantly reduce these effects through minimally invasive methods may allow patients to return to regular, active lives with less interruption and pain. The minimally invasive approach has been described as delivering the same advantages to spinal fusion surgery as arthroscopy has to knee surgery and laparoscopy to gall bladder surgery. For an overview of companies in the spinal fusion space, see Table 9 below.

Vertelink (Irvine, California), a venture-funded, privately held company, has developed percutaneous spinal fusion technology that delivers a posterior spinal fusion construct through four small holes no larger than 10 mm. The company, founded in 2001, was acquired by Medtronic last November, following the NASS meeting, for $22 million in cash and undisclosed additional payments as regulatory milestones are met. The technology was developed with input from both neurosurgeons and orthopedic spinal surgeons and uses pioneering materials and techniques (similar to those used in interventional cardiology) for over-the-wire spinal fixation devices that can achieve multi-level stabilization of the cervical, thoracic and lumbar spine.

The Vertelink Kobra GPS Fixation System for Guided Percutaneous Stabilization, which has been submitted for 510(k), uses conventional metallic-based materials (i.e., titanium and stainless steel) combined with a proprietary percutaneous delivery system. One of the cornerstones of this delivery system is the Vector expandable access technology, a series of small tissue-gentle sheaths for minimally invasive surgical procedures. Once the sheath slides into the tissue over a wire, it can then be expanded to two to three times the initial deployment diameter. The fully expanded Vector sheath acts as a pathway for over-the-wire pedicle screw insertion and may have other clinical uses in spinal and general orthopedic markets. The pedicle screws and rods are placed entirely with percutaneous interventional techniques.

Vertelink also developed the SST Polyflex System that combines traditional metallic components with unique composite material used in aerospace technology delivered with techniques used in other interventional fields. The expandable rod, to be available in lengths for multilevel fixation, provides strength equal to or stronger than conventional metallic devices used in surgical spinal fixation. Since the SST Fixation actually expands within the body and conforms to each individual patient's anatomy, this technology provides solutions not achievable with rigid titanium or stainless steel instrumentation. The SST System has been designed to interface with new bone matrix materials and orthobiologics developed to replace the use of autologous bone in the creation of spinal fusions. The delivery of these devices is percutaneous requiring small needle punctures instead of surgical incisions.

Medtronic Sofamor Danek (Memphis, Tennessee) was the pioneer in minimally invasive spinal fusion procedures using muscle-splitting dilator tubes to access the lumbar spine through small skin incisions and tunnels created by separating muscle along its natural divisions. Minimal Access Spinal Technologies (MAST) is a division of Medtronic Sofamor Danek that develops and manufactures products that treat a variety of disorders of the cranium and spine. Its minimally invasive spinal fusion system, the CD Horizon Sextant system was introduced in April 2002 and is designed to enable in situ fixation with minimum trauma to surrounding muscle and tissue. The original design was limited in its inability to apply corrective forces to the spine and its restriction to the placement of only two screws on each side. A system modification was introduced at NASS, designed to provide limited two-level capabilities. While still a new technology, several preliminary studies have been published on the clinical results of the system showing good results.

NuVasive (San Diego, California) provides a method to deliver less invasive access to the surgical site for spinal surgery, allowing the surgeon to perform conventional spinal surgery using current surgical instruments while reducing patient morbidity, scarring and complications. The privately held company with $12 million in 2002 revenue raised $25 million in a Series D round in two tranches last July, including an investment from Johnson & Johnson Development (New Brunswick, New Jersey). Valuation for the round was between $75 million and $100 million, up from the company's previous venture financing.

NuVasive combines minimal access spine products with neural monitoring enabling surgeons to access the spine from a lateral approach. The technique referred to as XLIF 90 (Extreme Lateral Interbody Fusion) enables minimally invasive disc height restoration while minimizing musculature disruption. It uses the MaXcess Spinal Access system that is designed to provide maximum surgical access while allowing conventional visualization of the anatomy with reduced trauma to nearby structures. The system's modular blade assembly assures customized blade length for proper patient sizing. The operative corridor aperture is illuminated and may be expanded to the shape that best benefits the surgical approach. The split blade design allows instruments to be angled against the wounds edge to optimize position and safety. NuVasive has both a direct selling and distributor organization. Additionally, there are training facilities located throughout the U.S. for hands-on cadaver training.

Endius (Plainville, Massachusetts) closed a $26.5 million Series B financing in March of last year, marking one of the largest venture capital investments in a medical device company in 2003, which will be used to further accelerate market penetration for Atavi, Endius's atraumatic spine surgery system. This system provides access, visualization and instrumentation through a minimally invasive approach, while preserving the fundamentals of the traditional open surgical technique. Founded in 1997, Endius is a pioneer in minimally invasive spine surgery products to treat serious spine disease. Approved by the FDA in October 2000, the Atavi (Atraumatic Access Visualization Instrumentation) spine surgery system has undergone several product improvements. The technology allows surgeons to perform single and two-level fusion, fixation, decompression and lumbar interbody fusion through an access portal on each side of the spine using familiar techniques. A retractor with an expandable distal tip is placed through a small incision and then expands to establish and maintain substantial exposure of the targeted areas of the spine. It can be used endoscopically and is compatible with surgical loupes and a microscope, which allow surgeons to select the visualization method that best suits their needs.

To establish visualization endoscopically, the Atavi System uses a three-chip camera visualization system. Atavi also includes a light guide, spine scope and scope retractor mount, enabling identification of the anatomy, site preparation and delivery of implants and bone graft. With this system, the surgeon can visualize and access the surgical site for up to two levels, visualize and expose the interbody disc space, navigate precisely with real-time viewing and identify tissue that may require coagulation.

Atavi's integrated surgical system combines access technology, visualization and instrumentation capabilities to create maximum access at the spine where there would otherwise be no potential for operative space. Endius' minimally invasive approach potentially minimizes "fusion disease" or "failed back syndrome," a condition attributed to trauma to surrounding muscle tissue caused while gaining access to the surgical site during the traditional invasive open fusion procedure. Fusion disease and/or failed back syndrome can lead to chronic post-operative pain even if the radiographic fusion is successful.

More than 800 patients have been treated with Atavi by 128 surgeons nationwide. Of these, most leave the hospital within 24 hours. Clinical results for Endius' single-level endoscopic lumbar spine fusion procedure show benefits compared to the open procedure, including a 65% reduction in patient pain associated reduction in the use of narcotic pain medications, and reduced hospital stay(s) contributing to a potential 21% reduction in hospital costs.

DePuy Spine, a Johnson & Johnson company previously known as DePuy AcroMed, has been developing products to treat spinal disorders for more than 20 years. At a meeting in late October, DePuy announced the formation of both DePuy Spine and DePuy Biologics, with a target to increase its U.S. sales force by 35% and increase R&D investment by 49%. In June of last year, it acquired the Link Spine Group, which provided DePuy with exclusive worldwide rights to the SB Charit Artificial Disc, the principal Link Spine product. Two-year patient follow-up was completed in December, and DePuy Spine anticipates submitting a premarket approval application to the FDA this year. The SB Charit Artificial Disc has more than 15 years of clinical experience in Europe and is approved and marketed in more than 30 countries.

DuPuy Spine also has a spinal access system, called Aperture, to allow simultaneous retraction of lateral musculature while guiding pedicle instruments and implants for treatment of most lumbar degenerative conditions. Aperture employs traditional surgical techniques through a single, minimally invasive approach and can be used in single and multilevel procedures. With a small midline incision, intermuscular access is achieved with an outer retractor that opens the path to the pedicle with minimal vascular trauma. Muscle detachment or disruption is minimized using an inner guide to align pedicle preparation instruments and retain medial tissue. The system is designed to be used with multiple DePuy Spine systems for single and multiple level procedures.

Spinal Concepts was acquired by Abbott Laboratories in June and continues to be a leader in technology, with more than 40 U.S. patents, 22 foreign patents and numerous additional patents pending. The acquisition added to Abbott's existing platform in medical devices, providing an entry into the expanding spinal device market and a pipeline of developing products. Spinal Concepts had raised more than $42 million in capital, including a $21 million Series E round in August 2001. The company posted revenue growth of 619% from 1999 to 2001, going from $2.25 million to $16.2 million. For 2002, Spinal Concepts recorded revenue of $27 million. Revenues for 2003 were projected to be $40 million to $45 million. Spinal Concepts is continuing to use its contracted independent sales force within the U.S. and distributors internationally.

Shown at the NASS meeting was the PathFinder, Spinal Concepts' entr e into the minimally invasive spinal fixation marketplace. The PathFinder system enables percutaneous placement of PathFinder polyaxial pedicle screws. The system is approved for single and multilevel posterior instrumentation to treat the indications normally addressed by traditional, open pedicle screw systems such as degenerative disc disease and spinal stenosis. The entire single level procedure is performed by the spinal surgeon through two 3 cm incisions, instead of the usual 10 cm incision. The surgeon obtains access to the pedicle with a C-shaped sleeve. Within the channels of that sleeve, guided by fluoroscopic imaging, the surgeon introduces the pedicle screws, rods and necessary instruments to fit the rod to the screws and the screws to the bone. The extender sleeves of the PathFinder system allows for the application of compression, distraction, and reduction forces to the screws. Spinal Concepts has trained more than 400 physicians in regional one-day cadaver lab training sessions, completing 20 trainings with 20 to 25 physicians per session. The 300th PathFinder System was implanted in September, and physicians have begun initiating multilevel fixation.

TranS1 (Wilmington, North Carolina), a privately held company focused on percutaneous procedures to treat lower back pain, secured a $12 million Series B round in May 2003. The company had 10 employees at the time of the NASS meeting. Proceeds from the financing are being used to complete the development of the company's lumbar spine surgery product that is scheduled to enter a clinical study of 510(k)-approved fusion devices in 2Q04. Seven clinical devices have been successfully implanted and all have allowed the patients to go home the next day.

TranS1, formerly known as Axiamed, was founded in 2000 by Andrew Cragg, MD, a Minneapolis-based interventional surgeon. The company has developed an approach to accessing the lumbar spine through a percutaneous opening via the sacral bone using methods in spine that are similar to those used in angioplasty and arthroscopy. This procedure is designed to enable surgeons to perform a range of spine fusion, nucleus and disc replacement procedures with specialized percutaneous instrumentation, avoiding the dissection or penetration of any surrounding spinal tissue through advancement of access devices between the bowel and the anterior sacrum. This spares the spine from further trauma and reduces recovery time and discomfort for patients. The company believes the approach will enable surgical procedures such as multi-level lumbar fusions and nucleus replacements to be performed on an outpatient basis. The company also is developing a variety of implants that can be placed in the disc space to achieve fusion and alleviate pain in the lower spine.

Neurostimulation reduces back pain

One of the other areas of minimally invasive technology under explosive growth is the treatment of pain using neuromodulation. Neuromodulation is defined as the therapeutic alteration of activity in the central, peripheral or autonomic nervous systems, electrically or pharmacologically, by means of implanted devices. The goal of neuromodulation is to reduce rather than eliminate pain. More than 34 million people in the U.S. suffer from chronic pain, and many do not respond to currently available treatment methods including oral medications and surgical intervention. Published studies of the therapy have shown that when used on carefully selected chronic pain patients, neurostimulation may improve pain relief (a majority of patients may experience at least 50% reduction in pain), increased activity levels and reduced use of narcotic medications. These results may also lead to reduced hospitalizations and surgical procedures, reduced healthcare costs, greater independence and improved quality of life.

There are 10 million people in the U.S. suffering from failed back syndrome, chronic back and/or peripheral pain, of which 10% typically do not respond to modifications in lifestyle, exercise, physical therapy or conventional medical therapy. The effectiveness of oral medications also diminishes with long-term use, and increased dosages may also be accompanied by deleterious side effects. Pharmaceutical and device companies are at the crossroads. The confluence of various market drivers, micronization of technology, improved wireless technology, emerging pharmacologics with improved efficacy, increased expectations for quality of life for an aging population and more are responsible for the current high growth in the implantable drug pump and spinal cord stimulator markets and is predicted to contribute to these products becoming an increasing part of pain management in the future. More than 17,500 spinal cord stimulators are implanted worldwide annually, at an average sales price of $16,000 to $16,500. Both spinal cord stimulators and implantable intrathecal pumps also are used to manage nerve injury, movement disorders, spasticity and epilepsy.

Spinal cord stimulators deliver low-voltage electrical stimulation to the spinal cord or targeted peripheral nerve to modulate the sensation of pain with a comfortable tingling sensation in the affected area. There are two different types of spinal cord stimulators, one that is entirely implantable with a battery that lasts several years, and one with an external power source. Implantable drug pumps deliver minute amounts (approximately 1/300 of an oral morphine dose) of continuous intraspinal opioid therapy and also come in two varieties; one that can deliver medication at a single constant rate and another that can be programmed and modified as desired to deliver a drug at varied times and rates. Both spinal cord stimulators and implantable pumps for the intrathecal delivery of drugs are able to validate efficacy prior to implantation of the device during a brief trial of either technology. Successful relief of pain during this time ensures that Medicare or third-party payers will reimburse the technology.

During a spinal cord stimulator screening trial, a percutaneous lead is implanted above the spinal cord in the epidural space and connected to a temporary external power source. This lead is positioned to cover as much of the patient's area of pain possible. Dialog between the physician and patient helps to determine if this technology provides the desired level of pain relief. Studies of spinal cord stimulator patients have shown that about 75% of patients find significant persistent pain relief. After the brief trial, usually two to three days in length confirms efficacy, a permanent stimulator, similar in size to a pacemaker, is implanted in the abdominal area.

The screening trial for intrathecal pumps is usually accomplished with a bolus of pain medication the physician delivers into the cerebrospinal fluid that surrounds the spinal cord. After efficacy of the medication is confirmed, a minimally invasive surgical procedure is performed implanting the pump, currently about the size and shape of a hockey puck, in a subcutaneous pocket in the abdomen.

Medtronic had net revenue for all neurological products (including movement disorders, pain management and incontinence) of $745 million in fiscal 2003, exhibiting 15% growth from 2002. Projected annual growth for this combined market is estimated at 15%+ over the next several years. Medtronic has a full complement of devices for neuromodulation, including implantable intrathecal pumps providing constant flow and programmable drug delivery, and implantable pulse generators. Revenue in 2003 from neurostimulation products alone is estimated at about $341 million. The market for implantable drug pumps (programmable and constant flow) was projected to approach $260 million in 2003, including some of the drugs and disposables. Medtronic is the dominant competitor, controlling more than 90% of the market and selling infusion pumps for pain management and for the treatment of spasticity.

The implantable neurostimulator leads can be implanted percutaneously by a pain physician or through a surgical laminectomy by a surgeon. The implantable pulse generator is available with an RF wireless model, or a fully implantable model with a battery that has an average life of three to six years, depending on the usage.

The SynchroMed implantable intrathecal pumps have been available since 1991 for the delivery of intraspinal morphine for chronic pain and in 1997 approval was added for the intrathecal delivery of baclofen for spasticity, and spinal cord injury. The pump is also indicated for treatment of spasticity of cerebral origin including cerebral palsy, stroke and brain injury. The programmable SynchroMed EL pump, about the size of a hockey puck, costs about $9,000 and is available in either a 10 ml or 18 ml size. Although not shipped for sale anywhere in the world yet, the new SynchroMed 2 pump is approved for sale in Europe and the U.S. and addresses the need for increased drug volume and decreased size. The SynchroMed 2 pump was approved for sale by the FDA in September 2003. This new programmable pump comes in 20 ml and 40 ml sizes and is 30% smaller with a more ergonomic shape. Outside the U.S., the pump also will be available with a hand-held Patient Controlled Analgesia (PCA) activator that will allow the patient to self-deliver an intermittent bolus of medication up to physician programmed limits. The PCA was to be made available to a selected group of patients in Europe at the beginning of this year.

Advanced Neuromodulation Systems (ANS, Plano, Texas), a publicly held company offering spinal cord stimulators, exhibited both its Genesis and Renew neurostimulation products at NASS. ANS also sells a constant-flow intrathecal pump outside the U.S. The market for spinal cord stimulator sales is growing in excess of 20% a year, and ANS has carved out a significant share since its inception seven years ago as a spin-off from Quest Medical.

Recently recognized by Fortune magazine as one of the 100 fastest-growing small companies, ANS continues to innovate. The leads on its spinal cord stimulators have a longer electrode span with more closely spaced electrodes, which the company believes provide a more focused delivery of stimulation for the relief of pain and allow for repositioning of the stimulation to accommodate changing pain patterns. ANS offers both a fully implantable battery-operated system and one that is driven by an external radiofrequency-powered device. The Genesis XP system offers the industry's longest-lasting battery with a wide range of stimulation programs. The Renew system has an external rechargeable battery.