Medical Device Daily Contributing Writer

SAN FRANCISCO — Several important themes were highlighted at last week's annual meeting of the North American Spine Society (NASS; Burr Ridge, Illinois) and several growth companies caught the attention of Medical Device Daily.

Physician interest in 1) lateral access spine procedures, 2) motion preservation, and 3) minimally invasive surgery (MIS) procedures continue to increase.

Lateral access was pioneered by NuVasive (San Diego, California) and is now being adopted quickly by physicians across the U.S. who were not early adopters. Medtronic (Minneapolis, Minnesota), Johnson & Johnson (J&J; New Brunswick, New Jersey), and Synthes (Zurich, Switzerland) are reacting to physician interest by following NuVasive with similar lateral access products.

Motion preservation adoption is expected to increase significantly over the next five years as next generation products are approved, five year outcomes data is published, and insurance coverage grows.

New minimally invasive spine surgical techniques are building on kyphoplasty and lateral access. Benefits of minimally invasive approaches include reduced patient blood loss and pain, quicker patient recovery, and less tissue and bone loss. Minimally invasive spacers and spinal decompression products are coming.

In response to physician interest, more companies including Medtronic, J&J, Synthes, Alphatec (Carlsbad, California), and Globus (Audobon, Pennsylvania) are offering or plan to offer lateral access approaches which compete with NuVasive's XLIF, the leading lateral access procedure. Importantly, lateral access requires neuro monitoring capabilities. The ease of neuro monitoring is a key driver for physician adoption because it offers safety to the procedure and confidence for the physician. Notably, integration of the neuro monitoring equipment into the procedure differs by company, with NuVasive being the leader.

NuVasive continues to improve its platform technology with add on products which continue to take significant market share from Medtronic, Johnson and Johnson, and Synthes. NuVasive's lateral approach is increasingly being used for multi-level cases. NuVasive is also moving into the thoracic spine with product introductions for more complex cases including corpectomy and scoliosis. During NASS, NuVasive hosted an upbeat analyst lunch focused on the experience of their four physician panel.

Motion preservation coverage is improving

Patients, spine surgeons, and neurosurgeons remain excited about artificial discs for motion preservation. Insurance coverage for motion preservation has been a major impediment to physician adoption since very few insurers cover motion preservation procedures. However, insurance companies are beginning to cover the procedure for more patients. Companies are optimistic this trend will continue. Five year outcomes data has been presented in posters with favorable outcomes. As this data becomes published in peer review journals, this will help to convince more insurers to cover motion preservation.

Although the current U.S. market is limited due to lack of coverage, the motion preservation market is poised to increase significantly as more data is published and insurer coverage expands. The U.S. cervical motion preservation market is estimated at 3,000 procedures and the U.S. lumbar motion preservation market is estimated at 2,000 procedures according to industry sources. Companies are expecting more than 30% annual growth in cervical and single digit growth in lumbar going forward. Johnson and Johnson, Medtronic, and Synthes have discs approved in the U.S. and will benefit from coverage expansion. Additionally, many companies have discs in U.S. trials and development including Spinal Motion (Mountain View, California), Spinal Kinetics (Sunnyvale, California), NuVasive, and Globus.

More minimally invasive technologies are coming

A minimally invasive procedure which has been well received by physicians is kyphoplasty. The efficacy debate surrounding kyphoplasty continued at NASS with presentation of the results of the Fracture Reduction Evaluation (FREE) trial showing that balloon kyphoplasty improved patients' quality of life and reduced back pain and disability. The study included 300 patients treated at 21 sites in 8 countries.

Competition in the vertebrocompression fracture (VCF) market is expected to increase as more companies have entered the global market to compete with Medtronic's kyphoplasty. Competitors include: Alphatec, Johnson and Johnson, DFine (San Jose, California), SpineWave (Shelton, Connecticut), Benvenue Medical (Santa Clara, California), and Soteira (Natick, Massachussetts). Benvenue Medical has not yet begun its U.S. clinical study and Soteira is awaiting 510(k) approval.

Orthovita (Malvern, Pennsylvania) recently launched its vertebroplasty product, Cortoss, an injectable polymer composite that mimics the structural characteristics of human bone. The company hosted an upbeat investor breakfast with physician testimonials at NASS.

Several growth companies with minimally invasive technologies that were of interest included: Baxano, Innvotec, SpineWave, and Globus.

Baxano (Mountain View, California) launched the iO-Flex system at NASS. This system utilizes thin, flexible instruments to provide precision lumbar decompression from the "inside out". iO-Flex minimizes muscle trauma by allowing bilateral decompression through single-port access. The controlled "over the wire" system is designed to target and decompress bone and soft tissue in the foramen, lateral recess, and central canal. It preserves facet joint integrity, thus maintaining biomechanical stability.

Innvotec (Brisbane, California) has a hydraulically expandable interbody technology. The design intent is to bring a family of interbody implants to the market which achieve a less invasive, anatomic fusion in a system that is easy to use while minimizing procedural complications and maintaining proper sagital balance. Innvotec recently received its first FDA 510(k) approval. The initial system is being refined and plans are in place for a full product line based on size, materials, and access location.

SpineWave (Shelton, Connecticut), markets the StaXx XD Expandable Device. This PEEK spacer allows for controlled in situ distraction in 1mm increments. The low-profile, expandable design allows for a significantly smaller working channel compared to standard spacers. This may result in less bone removal and nerve retraction. The StaXx XD spacer is designed to provide optimal distraction and precise implant fit, while providing controlled implant insertion. SpineWave also markets the StaXx FX structural kyphoplasty system, and the CapSure PS2 spine system in the U.S.

Globus (Audubon, Pennsylvania) has quickly become a leader in U.S. spine market. Globus has a complete suite of spinal products including minimally invasive surgery, fusion, motion preservation, and biomaterials. Globus routinely collaborates with spine surgeons to develop custom products to meet the physicians' needs and improve patient outcomes. Globus' in-house prototype shop produces custom implantation modifications within 24 hours to meet medical emergencies, and routinely produces custom products with a 7-day turnaround. This attentiveness to physicians has built strong customer loyalty and earned Globus a leadership position in the eyes of physicians across the country.