11.20.12
The DePuy Synthes Spine unit of Johnson & Johnson showcased a few new product launches during the 27th annual meeting of the North American Spine Society (NASS, held Oct. 23-27) in Dallas, Texas. The company released its ACIS Anterior Cervical Interbody Spacer System, which is a set of spacers and instrumentation for anterior cervical discectomy and fusion. The company also launched the Spotlight PL Access System, which the firm claims is the first access system designed specifically for minimally invasive posterior-lateral fusion.
ACIS System spacers are offered in three axial footprints (12.5, 14 or 16 millimeter widths), eight heights (5-12 millimeters) and three sagittal profiles (lordotic, parallel or convex) to accommodate individual patient anatomy and surgical techniques. The spacers are made of PEEK Optima (polyetheretherketone) radiolucent material and feature a large axial lumen to maximize the area for packing autogenous bone graft and enable fusion to occur through the spacer, according to the company. The ACIS system is intended for use with supplemental fixation.
“The ACIS system is very comprehensive and user friendly, especially with the shorter instruments, which are easier to use under the scope. The three different spacer sizes provide a good option for all patients and all levels. The larger lumen and the ability to insert large amounts of graft material is very important for adequate fusion and stability,” said Ali Chahlavi, M.D., a neurosurgeon at St. Vincent’s Medical Center in Jacksonville, Fla., and a consultant to DePuy Spine.
The Spotlight system includes a set of retractors of various lengths with integrated fiber optic lighting and decortication instruments, all of which are designed for use with the company’s Viper 3-D MIS Correction Set.
“This new retractor delivers the benefits of a minimally invasive approach to posterior lateral fusion. The Spotlight PL System provides excellent visibility and allows me to perform up to a four level posterior lateral fusion through only one incision,” according to Amer Samdani, M.D., a physician at Shriners Hospitals for Children in Philadelphia, Pa., and also a paid consultant to the company.
Posterior-lateral fusion, a procedure where surgeons place graft material along the sides of the vertebrae to stimulate bone growth and promote fusion, is used to treat conditions including degenerative disc disease, spinal stenosis, scoliosis and other complex spinal deformities.
“The Spotlight PL Access System will enable surgeons to provide patients with a less-invasive alternative to traditional surgery,” said Namal Nawana, worldwide president of DePuy Synthes Spine.
Medtronic Uses NASS For Multiple Products Launches
Medtronic Inc.’s Spinal division also was prolific with new product introductions during NASS’s meeting.
Among the new rollouts were devices that reinforce the Minneapolis, Minn-based company’s portfolio of posterior degenerative interbody technology, expanding Medtronic’s broad offerings for both open and minimally invasive procedural solutions. The launch featured posterior interbody devices that expand, rotate and articulate.
The interbody portfolio includes the Wave platform of products with expandable implants for posterior lumbar interbody fusion surgeries. To broaden the offerings for lumbar interbody fusions, the new portfolio also features a pivoting implant for easier placement as well as a titanium implant that can be inserted and rotated longitudinally.
The products are available for sale in the United States and Europe, and come to Medtronic following the May acquisition of the German spinal implant firm Advanced Medical Technologies AG (AMT).
The company also launched the Capstone Control Spinal System. With the ability to insert and rotate longitudinally, the system provides an interbody device with the potential for less neural retraction when compared to the impacted technique, according to the company. Risks of this device include possible neurological impairment.
“We have strengthened our industry leading lumbar interbody fusion portfolio that increases surgeon options in treating the unique needs of their patients,” said Doug King, senior vice president and president of Medtronic Spinal. “It also provides customers and patients with greater access to established technologies through our sales distribution network, while AMT’s strong presence outside the United States further globalizes our business.”
Interbody fusion devices are used with autogenous bone graft and supplemental fixation instrumentation cleared for use in the lumbar spine in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients also may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
MIS Spinal Fusion System Introduced
Medtronic also unveiled its Oblique Lateral Interbody Fusion (OLIF) 25 Procedure for minimally invasive spinal fusion. According to the company, the procedure allows for psoas preserving access to the L2-L5 levels and incorporates Medtronic’s surgical platform of access, interbody, neuromonitoring, navigation, fixation and biologic options. The psoas is a long muscle located on the side of the lumbar region of the back.
The procedure leverages traditional anterior lumbar interbody fusion principles with the in-situ convenience of the less-invasive lateral approach. Using an oblique lateral trajectory away from the posterior nerves within the psoas muscle, this procedure is an alternative to approaches dependent on neuromonitoring to traverse the psoas muscle. In addition, the OLIF25 procedure allows for easier access around the iliac crest at L4-L5, and it is a step toward more reproducible lateral access to the L5-S1 disc space, according to Medtronic officials.
“The OLIF25 Procedure combines the advantages of the open retroperitoneal approach to the anterior spine with the minimally invasive access benefits from more recent lateral techniques,” said Richard Hynes, M.D., spine surgeon at The B.A.C.K. Center in Melbourne, Fla. “By utilizing an oblique lateral approach to the spine, this procedure enables placement of a large interbody graft into the disc space for anterior column support and segmental sagittal alignment while minimizing the nerve, muscle, and bone obstacles associated with traditional direct lateral approaches.”
In the United States, more 250,000 people undergo spinal fusions annually to treat degenerative changes in the lumbar spine.
Screw System Unveiled
Another of Medtronic’s new product rollouts at NASS was the Anchor FS Facet Fixation System, a minimally invasive posterior screw system used in the lumbar region of the spine. It is used to provide stability by fixation through the facet joints. The system includes a single-use sterile packed instrument set with a variety of cannulated screw options to accommodate varying patient anatomy.
Anchor FS is indicated for posterior surgical treatment of any or all of the following in the lumbar region of the spine, at single or multiple levels: trauma, including spinal fractures and/or dislocations; spondylolisthesis; spondylolysis; pseudoarthrosis or failed previous fusions that are symptomatic or may cause secondary instability or deformity; degenerative disc disease as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies; and/or degenerative disease of the facets with instability.
The system is intended to stabilize the spine as an aid to lumbar fusion by providing bilateral facet fixation, with or without bone graft. It is the latest technology in a series of therapies that compliments Medtronic Spinal’s minimally invasive MAST portfolio to treat patients for a variety of degenerative and deformity spinal conditions.
The Spinal division of Medtronic is in Memphis, Tenn.
FDA OKs Cervical Disc Systemfrom NuVasive
Talk about saving the best for last. During the penultimate day, Oct. 26, of the nearly weeklong annual meeting of NASS, San Diego, Calif.-based NuVasive Inc. revealed that the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the company’s PCM cervical disc system.
Company officials said the device is a motion preservation option in the cervical spine instead of a traditional, motion-eliminating fusion procedure. The FDA approval follows the completion of a prospective, multicenter randomized investigational device exemption clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients.
The PCM device is composed of cobalt chrome endplates and a central polyethylene core. The broad radius of the polyethylene core allows for unconstrained motion preservation and a broad radius of articulation for coupled motion, company officials noted. The device has a wide footprint to capitalize on the most stable portions of patients’ cervical vertebral bodies. It offers three footprint and height options. The superior and inferior endplates also feature three rows of “V-Teeth,” which provide short-term fixation until long-term fixation can occur to anchor the device.
Alex Lukianov, chairman and CEO called the device a “game-changing solution” for the cervical spine, and represents a new market for the company.
“This device has many design considerations that make it a truly unique product offering compared to other cervical motion preserving devices,” Lukianov said. “Its low-profile design enables it to be minimally disruptive to the adjacent anatomy and a viable treatment option for levels adjacent to prior fusions.”
According to Laetitia Cousin, vice president of Regulatory and Clinical Affairs at NuVasive, the strong clinical data “speaks for itself.” She called the effort to reach the PMA “monumental.”
The PCM implant is indicated for adult patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging: herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The device is
implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment prior to implantation.
In the long term, the device could mean stronger sales for NuVasive, according to Leerink Swann analyst Richard Newitter. While he doesn’t expect the device to generate material revenue before early to mid-2013, “more color” about the company’s launch strategy should develop following investor meetings.
“We will wait to adjust our estimates pending additional guidance at these investor events,” he said.
The Spotlight PL Access System. Photo courtesy of DePuy Synthes Spine. |
“The ACIS system is very comprehensive and user friendly, especially with the shorter instruments, which are easier to use under the scope. The three different spacer sizes provide a good option for all patients and all levels. The larger lumen and the ability to insert large amounts of graft material is very important for adequate fusion and stability,” said Ali Chahlavi, M.D., a neurosurgeon at St. Vincent’s Medical Center in Jacksonville, Fla., and a consultant to DePuy Spine.
The Spotlight system includes a set of retractors of various lengths with integrated fiber optic lighting and decortication instruments, all of which are designed for use with the company’s Viper 3-D MIS Correction Set.
“This new retractor delivers the benefits of a minimally invasive approach to posterior lateral fusion. The Spotlight PL System provides excellent visibility and allows me to perform up to a four level posterior lateral fusion through only one incision,” according to Amer Samdani, M.D., a physician at Shriners Hospitals for Children in Philadelphia, Pa., and also a paid consultant to the company.
Posterior-lateral fusion, a procedure where surgeons place graft material along the sides of the vertebrae to stimulate bone growth and promote fusion, is used to treat conditions including degenerative disc disease, spinal stenosis, scoliosis and other complex spinal deformities.
“The Spotlight PL Access System will enable surgeons to provide patients with a less-invasive alternative to traditional surgery,” said Namal Nawana, worldwide president of DePuy Synthes Spine.
Medtronic Uses NASS For Multiple Products Launches
Medtronic Inc.’s Spinal division also was prolific with new product introductions during NASS’s meeting.
Among the new rollouts were devices that reinforce the Minneapolis, Minn-based company’s portfolio of posterior degenerative interbody technology, expanding Medtronic’s broad offerings for both open and minimally invasive procedural solutions. The launch featured posterior interbody devices that expand, rotate and articulate.
The interbody portfolio includes the Wave platform of products with expandable implants for posterior lumbar interbody fusion surgeries. To broaden the offerings for lumbar interbody fusions, the new portfolio also features a pivoting implant for easier placement as well as a titanium implant that can be inserted and rotated longitudinally.
The products are available for sale in the United States and Europe, and come to Medtronic following the May acquisition of the German spinal implant firm Advanced Medical Technologies AG (AMT).
The company also launched the Capstone Control Spinal System. With the ability to insert and rotate longitudinally, the system provides an interbody device with the potential for less neural retraction when compared to the impacted technique, according to the company. Risks of this device include possible neurological impairment.
“We have strengthened our industry leading lumbar interbody fusion portfolio that increases surgeon options in treating the unique needs of their patients,” said Doug King, senior vice president and president of Medtronic Spinal. “It also provides customers and patients with greater access to established technologies through our sales distribution network, while AMT’s strong presence outside the United States further globalizes our business.”
Interbody fusion devices are used with autogenous bone graft and supplemental fixation instrumentation cleared for use in the lumbar spine in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients also may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
MIS Spinal Fusion System Introduced
Medtronic also unveiled its Oblique Lateral Interbody Fusion (OLIF) 25 Procedure for minimally invasive spinal fusion. According to the company, the procedure allows for psoas preserving access to the L2-L5 levels and incorporates Medtronic’s surgical platform of access, interbody, neuromonitoring, navigation, fixation and biologic options. The psoas is a long muscle located on the side of the lumbar region of the back.
The procedure leverages traditional anterior lumbar interbody fusion principles with the in-situ convenience of the less-invasive lateral approach. Using an oblique lateral trajectory away from the posterior nerves within the psoas muscle, this procedure is an alternative to approaches dependent on neuromonitoring to traverse the psoas muscle. In addition, the OLIF25 procedure allows for easier access around the iliac crest at L4-L5, and it is a step toward more reproducible lateral access to the L5-S1 disc space, according to Medtronic officials.
“The OLIF25 Procedure combines the advantages of the open retroperitoneal approach to the anterior spine with the minimally invasive access benefits from more recent lateral techniques,” said Richard Hynes, M.D., spine surgeon at The B.A.C.K. Center in Melbourne, Fla. “By utilizing an oblique lateral approach to the spine, this procedure enables placement of a large interbody graft into the disc space for anterior column support and segmental sagittal alignment while minimizing the nerve, muscle, and bone obstacles associated with traditional direct lateral approaches.”
In the United States, more 250,000 people undergo spinal fusions annually to treat degenerative changes in the lumbar spine.
Screw System Unveiled
Another of Medtronic’s new product rollouts at NASS was the Anchor FS Facet Fixation System, a minimally invasive posterior screw system used in the lumbar region of the spine. It is used to provide stability by fixation through the facet joints. The system includes a single-use sterile packed instrument set with a variety of cannulated screw options to accommodate varying patient anatomy.
Anchor FS is indicated for posterior surgical treatment of any or all of the following in the lumbar region of the spine, at single or multiple levels: trauma, including spinal fractures and/or dislocations; spondylolisthesis; spondylolysis; pseudoarthrosis or failed previous fusions that are symptomatic or may cause secondary instability or deformity; degenerative disc disease as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies; and/or degenerative disease of the facets with instability.
The system is intended to stabilize the spine as an aid to lumbar fusion by providing bilateral facet fixation, with or without bone graft. It is the latest technology in a series of therapies that compliments Medtronic Spinal’s minimally invasive MAST portfolio to treat patients for a variety of degenerative and deformity spinal conditions.
The Spinal division of Medtronic is in Memphis, Tenn.
FDA OKs Cervical Disc Systemfrom NuVasive
The PCM cervical disc system. Photo courtesy of NuVasive Inc. |
Company officials said the device is a motion preservation option in the cervical spine instead of a traditional, motion-eliminating fusion procedure. The FDA approval follows the completion of a prospective, multicenter randomized investigational device exemption clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients.
The PCM device is composed of cobalt chrome endplates and a central polyethylene core. The broad radius of the polyethylene core allows for unconstrained motion preservation and a broad radius of articulation for coupled motion, company officials noted. The device has a wide footprint to capitalize on the most stable portions of patients’ cervical vertebral bodies. It offers three footprint and height options. The superior and inferior endplates also feature three rows of “V-Teeth,” which provide short-term fixation until long-term fixation can occur to anchor the device.
Alex Lukianov, chairman and CEO called the device a “game-changing solution” for the cervical spine, and represents a new market for the company.
“This device has many design considerations that make it a truly unique product offering compared to other cervical motion preserving devices,” Lukianov said. “Its low-profile design enables it to be minimally disruptive to the adjacent anatomy and a viable treatment option for levels adjacent to prior fusions.”
According to Laetitia Cousin, vice president of Regulatory and Clinical Affairs at NuVasive, the strong clinical data “speaks for itself.” She called the effort to reach the PMA “monumental.”
The PCM implant is indicated for adult patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging: herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The device is
implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment prior to implantation.
In the long term, the device could mean stronger sales for NuVasive, according to Leerink Swann analyst Richard Newitter. While he doesn’t expect the device to generate material revenue before early to mid-2013, “more color” about the company’s launch strategy should develop following investor meetings.
“We will wait to adjust our estimates pending additional guidance at these investor events,” he said.