Centinel Spine® Granted Australian Clearance for
STALIF L™ Minimally-Invasive, Lateral Integrated Interbody™ System

6-20-16_image1New York, NY, June 23, 2016 – Centinel Spine, Inc., (Centinel Spine), the pioneer of the No- Profile, Integrated Interbody™ fusion device market, is granted clearance for STALIF L™ No- Profile, Lateral Lumbar Integrated Interbody system by the Australian Therapeutic Goods Administration.

“This clearance expands our International No-Profile, Integrated Interbody market,” said John J. Viscogliosi, Chairman & CEO, Centinel Spine. “STALIF has enjoyed a long successful history in Australia and now STALIF L exemplifies our continued commitment to being the gold standard in Integrated Interbody devices. We are excited to bring the STALIF advantage to minimally-invasive spinal fusion surgery in Australia,” Mr. Viscogliosi continued.

STALIF L continues the thirty-year STALIF® heritage of innovation as STALIF L is the only lateral device to offer the benefits of no-profile, compressive lag fixation with proprietary anti-backout technology and 12-degrees of lordosis.

In addition to the above-mentioned STALIF benefits, STALIF L also offers a large chamber for bone graft to support fusion, optimized fixation with easily placed self-drilling, self-tapping screws and a variety of cage sizes to match patient anatomy.

Sam Scott-Young, Managing Director, Orthotech Orthopaedics Holdings, Ltd, Pty, exclaimed, “Orthotech is proud to represent Centinel Spine in Australia. We are excited to receive the STALIF L clearance enabling us to provide this innovative technology to our surgeon customers and their spine surgery patients. ”

Mr. Scott-Young continued, “The entire STALIF product portfolio, including the new STALIF L, and the Ti-ACTIVE™ technology, a texturized, titanium coating, allows our surgeon customers to offer their patients the most up-to-date spinal technologies with a heritage of more than 25 years of proven clinical success as a treatment for degenerative spinal pathologies.”

Centinel Spine also develops, manufactures, markets and sells the complete STALIF product family, which includes STALIF C®, STALIF C-Ti™, MIDLINE II™ and MIDLINE II-Ti™. STALIF C-Ti and MIDLINE II-Ti merge the proven clinical success of STALIF Integrated Interbody technology with Ti-ACTIVE, a texturized titanium coating developed with over 15 years of science and engineering experience. Recently, Centinel Spine received FDA clearance for ALTOS™ PCT, a posterior cervical stabilization system specifically designed for use in either the cervical lateral masses or cervical-thoracic pedicles.

For more information on STALIF L, please visit lateral.centinelspine.com.

About Centinel Spine, Inc.

Centinel Spine, Inc. is a privately-held spinal device company leading the development and commercialization of the No- Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.centinelspine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

This information in this press release is intended for audiences in Australia. For more information, please contact:
John Parry
Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484.887.8813
Email: cs@centinelspine.com

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Centinel Spine® Completes Successful Evaluation of
STALIF L™ Minimally-Invasive Lateral Integrated Interbody System

6-20-16_image1New York, NY, June 21, 2016 – Centinel Spine, Inc., (Centinel Spine), the pioneer of the No-Profile®, Integrated Interbody™ fusion device market, completes Alpha release of STALIF L™ No-Profile, lateral lumbar Integrated Interbody device cleared by the U.S. Food and Drug Administration (FDA).

STALIF L continues the thirty-year STALIF® heritage of innovation as STALIF L is the only lateral device to offer the benefits of no-profile, compressive lag fixation with proprietary anti-backout technology and 12-degrees of lordosis. “STALIF L exemplifies our continued commitment to being the gold standard in Integrated Interbody devices,” said John J. Viscogliosi, Chairman & CEO, Centinel Spine. “We are excited to bring the STALIF advantage to minimally-invasive spinal fusion surgery,” Mr. Viscogliosi continued.

In addition to the above-mentioned STALIF benefits, STALIF L also offers a large chamber for bone graft to support fusion, optimized fixation with easily placed self-drilling, self-tapping screws and a variety of cage sizes to match patient anatomy, including a 12-degree lordotic option.

Robert Kimber, MD, Performance Spine Institute, Gulfport, MS, explained, “Over the past year I have used the STALIF L to treat many of my patients in need of minimally-invasive lateral lumbar reconstruction spine surgery. I like the 12 degrees of lordosis and the fixation provided by the screws.”

“STALIF L has the unique feature of compressive lag fixation, which assists me in ensuring that the bony endplates compress the device and bone graft, which I believe to be optimum in accordance with Wolff’s law,” continued Dr. Kimber.

Centinel Spine also develops, manufactures, markets and sells the complete STALIF product family, which includes STALIF C®, STALIF C-Ti™, MIDLINE II™ and MIDLINE II-Ti™. STALIF C-Ti and MIDLINE II-Ti merge the proven clinical success of STALIF Integrated Interbody technology with Ti-ACTIVE™, a texturized titanium coating developed with over 15 years of science and engineering experience.

Upon the completion of its Alpha release with a variety of minimally-invasive retractor options, Centinel Spine begins to release the STALIF L system to spine surgeons in the United States. For more information on STALIF L, please visit lateral.centinelspine.com.

About Centinel Spine, Inc.

Centinel Spine, Inc. is a privately-held spinal device company leading the development and commercialization of the No-Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.centinelspine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:
John Parry
Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484.887.8813
Email: cs@centinelspine.com

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Centinel Spine® Launches MIDLINE II-Ti™ in Australia

hero_midlineii-ti_devicescrewsfluoro
New York, NY, May 26, 2016  Centinel Spine, Inc., (Centinel Spine), the pioneer of Stand-Alone, No-Profile®, Integrated Interbody™ fusion devices, launches MIDLINE II-Ti™, a Ti-ACTIVE™ coated, No-Profile, anterior lumbar Integrated Interbody device, in Australia.

“Following the successful MIDLINE II-Ti US launch, we are excited to introduce MIDLINE II-Ti in Australia to complement our STALIF® product offering and bring Ti-ACTIVE to anterior lumbar spinal fusion procedures here,” said John J. Viscogliosi, Chairman & CEO, Centinel Spine.

The MIDLINE II-Ti product family has been available in the United States for just over 9 months with the first clinical implantations by Jessica Shellock, MD, Texas Back Institute®, Plano, TX and James Billys, MD, Florida Orthopaedic Institute®, North Tampa, FL.

MIDLINE II-Ti, the most recent Centinel Spine innovation for anterior lumbar interbody fusion (ALIF) procedures, represents the sixth generation of STALIF technology. MIDLINE II-Ti blends the STALIF Integrated Interbody advantage with Ti-ACTIVE, a uniquely texturized, microporous titanium plasma coating, to form a novel technology and approach to ALIF procedures with 8° to 20° of lordosis, excellent radiographic visualization, three cancellous screws for stability and an optimal fusion environment.

“We first released Ti-ACTIVE on the STALIF C® product family back in 2014. Since then, Ti-ACTIVE is rapidly increasing our STALIF market share.” said Mr. Viscogliosi. He continued, “Ti-ACTIVE is the culmination of over 15 years of titanium coating science, engineering and experience. And, as with all Centinel Spine technology, Ti-ACTIVE has been designed to satisfy the unmet market need to promote fusion in ALIF procedures. There have been over 4,500 Ti-ACTIVE devices successfully implanted to date.”

“I have used STALIF C-Ti™ over the past year and I look forward to incorporating MIDLINE II-Ti™ into my practice,” said Laurence McEntee, MD, Pindara Hospital, Gold Coast. “I believe that MIDLINE II-Ti will offer my lumbar spine surgery patients the benefits of immediate insertion stability, compression at the graft site and an enhanced fusion environment.”

MIDLINE II-Ti is based upon the STALIF MIDLINE II™ product family. MIDLINE II was designed to offer surgeons increased ease of use by reducing the surgical envelope required to implant the device while maintaining the superior biomechanics that have underpinned thirty years of STALIF surgical success. In harmony with Wolff’s law, three strategically configured cancellous screws create additional compression at each treated segment. The Ti-ACTIVE coating increases the contact surface area and friction at the bony endplates. To date, over 1,000 MIDLINE II devices have been implanted.

Richard Laherty, MD, Queensland Neurosurgery and Spine, Australia, states, “I choose to use MIDLINE II as it minimizes my surgical incisions and provides a large graft chamber and up to 20° of lordosis for my anterior lumbar fusion procedures. Adding a titanium coating to this device will also provide clear radiographic visualization and a texturized surface for stability and fusion, which are the ultimate goals of my spine surgery procedures.”

Centinel Spine also develops, manufactures, markets and sells the complete STALIF product family, which includes STALIF C, STALIF C-Ti™ for anterior cervical discectomy fusion (ACDF) procedures and STALIF L™ for lateral lumbar interbody fusion (LLIF) procedures. Recently, Centinel Spine received FDA clearance for ALTOS™ PCT, a posterior cervical stabilization system specifically designed for use in either the cervical lateral masses or cervical-thoracic pedicles.

About Centinel Spine, Inc.

Centinel Spine, Inc. is a privately-held spinal device company leading the development and commercialization of the Stand-Alone, No-Profile, Integrated Interbody fusion technologies.  For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.centinelspine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD.   Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

This information in this press release is intended for audiences in Australia.

For more information, please contact:
John Parry
Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484.887.8813
Email: cs@centinelspine.com

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Centinel Spine® Expands STALIF® Internationally

hero_midlineii-ti_devicescrewsfluoro
New York, NY, May 24, 2016 Centinel Spine, Inc., (Centinel Spine), the pioneer of Stand-Alone, No-Profile®, Integrated Interbody™ fusion devices, expands its MIDLINE II-Ti™ product family, a Ti-ACTIVE™-coated, No-Profile, anterior lumbar Integrated Interbody device, in the United States and Australia.

MIDLINE II-Ti, the most recent Centinel Spine innovation for anterior lumbar interbody fusion (ALIF) procedures, represents the sixth generation of STALIF® technology.  MIDLINE II-Ti blends the STALIF Integrated Interbody advantage with Ti-ACTIVE, a uniquely texturized, microporous titanium plasma coating, to form a novel technology and approach to ALIF procedures with 8°,12°,16° and 20° of lordosis, excellent radiographic visualization and three cancellous screws for optimum stability.

“This expansion is enabling Centinel Spine to rapidly increase market share and represents another key milestone in our Ti-ACTIVE product portfolio,” said John J. Viscogliosi, Chairman & CEO, Centinel Spine.  “Ti-ACTIVE is the culmination of over 15 years of titanium coating science, engineering and experience.  And, as with all Centinel Spine technology, Ti-ACTIVE has been designed to satisfy unmet market needs.  There have been over 4,500 Ti-ACTIVE devices successfully implanted to date.”

MIDLINE II-Ti is based upon the STALIF MIDLINE II™ product family.  MIDLINE II was designed to offer surgeons increased ease of use by reducing the surgical envelope required to implant the device while maintaining the superior biomechanics that have underpinned thirty years of STALIF surgical success.  In harmony with Wolff’s law, three strategically configured cancellous screws create additional compression at each treated segment. The Ti-ACTIVE coating increases the contact surface area and friction at the bony endplates. To date around 1,000 MIDLINE II devices have been implanted.

Gunwant Mallik, MD, Columbus, OH, states “The compressive fixation provided by the three lag screws, lordosis options and size options are very important. The titanium-coated PEEK option provides additional surface area that enhances stability.” Additionally Jon White, MD, HOAG Orthopedic Institute, Irvine, CA commented “MIDLINE II represents the best ALIF device currently on the market due to the overall simplicity, dependability and comprehensive design rationale”.

Centinel Spine also develops, manufactures, markets and sells the complete STALIF product family, which includes STALIF C®, STALIF C-Ti™ for anterior cervical discectomy fusion (ACDF) procedures and STALIF L™ for lateral lumbar interbody fusion (LLIF) procedures.  Recently, Centinel Spine received FDA clearance for ALTOS™ PCT, a posterior cervical stabilization system specifically designed for use in either the cervical lateral masses or cervical-thoracic pedicles.

About Centinel Spine, Inc.

Centinel Spine, Inc. is a privately-held spinal device company leading the development and commercialization of the Stand-Alone, No-Profile, Integrated Interbody fusion technologies.  For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.centinelspine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD.   Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:
John Parry
Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484.887.8813
Email: cs@centinelspine.com

LBL 216 R01

Centinel Spine® Announces the FDA Clearance and First Implantation of ALTOS™

hero_altos_pct_fullspineNEW YORK, Jan. 21, 2016 – Centinel Spine, Inc., (Centinel Spine) announces the U.S. Food and Drug Administration (FDA) clearance of ALTOS™, a posterior cervical thoracic stabilization system indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine. The first surgical implantation of the ALTOS system was performed by Gery Hsu, MD, CRMC Medical Associates, Coffeyville, KS on January 4, 2016.

“Centinel Spine is dedicated to developing products that address surgical needs, anatomical challenges and surgeon requirements,” said John J. Viscogliosi, Chairman & CEO, Centinel Spine. ”We look forward to seeing the successful clinical outcomes and evidence that ALTOS was designed to achieve,” Mr. Viscogliosi continued.

ALTOS is the first FDA cleared posterior cervical thoracic system specifically designed for implantation into either the cervical lateral masses or the cervical-thoracic pedicles. This low profile, stabilization system offers both fully threaded and smooth shank polyaxial screws with 80 degrees of freedom for simple insertion in the most demanding spinal anatomies. The system also provides laminar hooks, connectors, straight and curved rods for customizable constructs that meet each patient’s anatomical needs to provide outstanding clinical outcomes.

Jason E. Garber, MD, FACS, Western Regional Center for Brain & Spine Surgery, Las Vegas, NV, explained, “ALTOS is a comprehensive system that was designed to provide the surgical versatility needed to address posterior cervical spinal pathologies. The low profile system is simple to insert minimizing patient trauma and surgical time. It can also be easily customized to successfully address many patients’ degenerative pathologies.”

In addition to ALTOS, Centinel Spine also develops, manufactures, markets and sells the complete STALIF® product family, which includes STALIF C®, STALIF C-Ti™, MIDLINE II™ and MIDLINE II-Ti™. STALIF C-Ti and MIDLINE II-Ti merge the proven clinical success of STALIF Integrated Interbody technology with Ti-ACTIVE™, a titanium coating engineered with over 15 years of science and experience to produce an optimized, surface topography enabling cellular proliferation.1, 2, 3, 4

“We are proud to deliver the ALTOS system, Ti-ACTIVE technology and STALIF product families to patients around the world,” explained Mr. Viscogliosi. “The ALTOS system exemplifies our commitment to advancing the standard of care in spinal fusion procedures with our clinically proven technologies.”

For more information on Altos PCT, please visit http://altospct.centinelspine.com.

About Centinel Spine, Inc.

Centinel Spine, Inc. is a privately-held spinal device company leading the development and commercialization of the Stand-Alone, No-Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.centinelspine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generating superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:
Tyler Haskins
Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8816
Email: cs@centinelspine.com

  1. Lebl DR. Mechanical performance of cervical TDRs in vivo. Spine (Phila, PA 1976) 2012 Dec 15; 37(26): 2151-60.
  2. References on File/Internal Reports; Centinel Spine, Inc. LBL 073 Rev 1.
  3. Centinel Spine Report VAL-2014-009.
  4. Centinel Spine Report CD12-03-07-038.

LBL 201 R01

Centinel Spine® Implants Its First STALIF® MIDLINE II-Ti™ Device

New York, NY, July 28, 2015 – Centinel Spine, Inc., (Centinel Spine) the pioneer of Stand-Alone, No-Profile®, Integrated Interbody™ fusion devices implants its first two STALIF® MIDLINE II-Ti™ devices at Texas Health Plano, Plano, TX and Florida Hospital Carrollwood, Tampa, FL. The MIDLINE II-Ti devices were implanted by Jessica Shellock, M.D., Texas Back Institute®, Plano. TX, and James Billys, MD, Florida Orthopaedic Institute®, North Tampa, FL.

“As a surgeon, MIDLINE II-Ti is the kind of technology I want to provide my patients,” said Dr. Shellock. “I am impressed and pleased with the simplicity of implantation, the immediate stability of the device and the visibility of the titanium coating on the postoperative imaging,” she continued.

The MIDLINE II-Ti device is designed with Ti-ACTIVE™, a multidimensional, texturized titanium coating engineered with over 15 years of science and experience to provide primary stability with an optimized topography enabling cellular attachment and proliferation as observed in a preclinical analysis. MIDLINE II-Ti is a no-profile anterior lumbar Integrated Interbody system used to treat degenerative pathologies in the lumbar spine.

Dr. Billys explained, “I have used STALIF ALIF implants for many years with excellent clinical outcomes as well as high fusion rates. I recently had the opportunity to place the new MIDLINE II-Ti, which has the same easy placement as the PEEK cage with the added advantages of the titanium coating.”

In addition to our Ti-ACTIVE coated MIDLINE II product family, Centinel Spine also offers Ti-ACTIVE in its STALIF C®, No Profile, Integrated Interbody system for anterior cervical spinal fusion procedures. Both STALIF C-Ti and MIDLINE II-Ti are available for use in spinal fusion procedures by contacting Centinel Spine.

“We are excited to provide this unique technology to patients around the world and to have the first few MIDLINE II-Ti devices implanted by Dr. Shellock and Dr. Billys,” explained John J. Viscogliosi, Chairman & CEO, Centinel Spine. “MIDLINE II-Ti continues our commitment to being the market leader by advancing the standard of care in spinal fusion procedures with our clinical proven STALIF technology,” John concluded.

About Centinel Spine, Inc.

Centinel Spine, Inc. is a privately-held spinal device company leading the development and commercialization of the Stand-Alone, No-Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.centinelspine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generating superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

John Parry
Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8810
Email: cs@centinelspine.com

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