X-spine Announces FDA Clearance of AXLE-PEEK Spinal Implant System
MIAMISBURG, Ohio- X-spine, an emerging leader in the design of devices for the treatment of spinal disease, today announced FDA clearance of the AXLE™-PEEK Interspinous Fusion System. The AXLE-PEEK expands on X-spine’s AXLE line of interspinous fusion devices. The new device incorporates an insert manufactured from PEEK-OPTIMA® from Invibio Biomaterial Solutions. With this clearance, X-spine can uniquely offer surgeons a choice of interspinous materials, either titanium or polymer, in a spinal fusion device.
“The proprietary modular design of the Axle system allows for different types of inserts to be placed in the interspinous space. Surgeons can now decide if PEEK polymer or oxide-blasted titanium alloy is the best choice for their specific needs and indications,” states Dr. David Kirschman, President and CEO of X-spine, “This type of innovation exemplifies our philosophy of putting the best options into the hands of the spine surgeon and patient.”
The AXLE™-PEEK Interspinous Fusion System joins X-spine’s continually expanding portfolio of innovative spinal devices, including the, the Calix™/Calix PC™ Intervertebral Fusion Systems, the FIXCET™ Facet Fixation System, the BUTREX™ Buttress Plating System, the FORTEX™ and X90™ Pedicle Screw Systems, the SPIDER™ Cervical Plating System, and the HGRAFT™ Spinal Allograft System. All X-spine implants are made in the USA.
About X-spine
X-spine (www.x-spine.com) is a developer and manufacturer of advanced, proprietary implants and instrumentation for surgery of the spine. Based in Ohio, the privately-held company manufactures and markets products worldwide for the surgical treatment of a broad range of spinal pathologies.
Contact:
Daniel Abromowitz
X-spine Systems, Inc.
937-847-8400
About Invibio
Invibio is a global leader providing high performance biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets. The company provides medical device manufacturers with PEEK-OPTIMA® polymer and compounds, MOTIS® polymer, ENDOLIGN® composite and PEEK-CLASSIX® polymer for the development of long- and short-term implantable medical devices.
For more information, please contact Invibio at:
+484 342 6004 (U.S.)
+44 (0) 1253 898000 (U.K.)
+852 2366 4448 (Asia Pacific)
or online at www.invibio.com.
November 15, 2011 11:00 AM Eastern Time
X-spine Announces FDA Clearance of Novel Calix-PC Implant System
MIAMISBURG, Ohio--(BUSINESS WIRE)--X-spine, a global manufacturer of devices for the treatment of spinal disease, today announced FDA clearance of the Calix PC™ Spinal Implant System to join its growing portfolio of innovative spinal devices. The Calix PC is an intervertebral body fusion system consisting of titanium coated PEEK (Polyetheretherketone) spinal implants. X-spine utilizes a unique plasma coating process to selectively adhere a frictional commercially-pure titanium coating to the bone-apposing surfaces of the device. As a result, the Calix PC demonstrates improved resistance to device expulsion versus a non-coated device in laboratory testing.
“The selective coating of plasma-sprayed titanium to a polymer substrate in an intervertebral implant is potentially the most important development in intervertebral fusion technology since the introduction of PEEK implants a decade ago,” states Dr. David Kirschman, President and CEO of X-spine. “The Calix PC provides the benefit of a metallic surface while preserving the desirable qualities of PEEK, namely bone-equivalent modulus and radiolucency.”
The Calix PC demonstrated 79% greater resistance to expulsion forces than the equivalent non-coated device in laboratory testing. “Optimal expulsion performance adds an additional safety factor in the critical early postoperative period, continues Dr. Kirschman, “This type of device exemplifies X-spine’s commitment to develop devices which add real value to the patient and surgeon. The clearance of the Calix PC represents the culmination of several years of technical hurdles to develop a safe, durable and reproducible process to integrate metallic and non-metallic biomaterials in a high-performance implant system.”
The Calix PC system joins X-spine’s continually expanding portfolio of innovative spinal devices, including the AXLE™ Interspinous Fusion System, the FIXCET™ Facet Fixation System, the FORTEX™ and X90™ Pedicle Screw Systems, the SPIDER™ Cervical Plating System, and the HGRAFT™ Spinal Allograft System. All X-spine implants are made in the USA.
X-spine (www.x-spine.com) is a developer and manufacturer of advanced technologies for the treatment of spinal disease. Based in Ohio, the privately-held company manufactures and markets surgical implants and instrumentation worldwide for the treatment of a broad range of spinal pathologies.
Contact:
Daniel Abromowitz
X-spine Systems, Inc.
937-847-8400
November 30, 2010 12:40 PM Eastern Time
X-spine Announces New FDA Product Clearance
“Today, patients and surgeons are demanding procedures that bridge the gap between non-invasive spine treatment and major procedures such as multiple level spinal fusion. The AXLE™ device addresses that demand in a manner that allows for the implanting surgeon to specifically tailor device components to achieve optimal function.”
The AXLE™ Interspinous Fusion System Offers New Less-Invasive Option for Spine Surgeons
MIAMISBURG, Ohio--(EON: Enhanced Online News)--X-spine, a global manufacturer of implants and instruments for spinal surgery, announced FDA clearance of its new AXLE™ Interspinous Fusion System. The system is designed to provide spinal stability for lumbar fusion procedures, including the treatment of degenerative disk disease, spinal tumors and trauma.
“An additional benefit of AXLE™ is that by being located on the spinous process, it is situated away from the spinal cord, spinal nerves and large blood vessels. This reduces the possibility of complications related to violation of these structures compared to traditional systems.” The AXLE™ system incorporates a novel modular design to allow for implant customization to conform to individual patient anatomy. The implant can be placed through a one inch incision in the back with minimal disruption of tissue. The device works by rigidly attaching to the rearmost portion of adjacent vertebrae, termed the spinous process, of the lower or middle spine.
“The AXLE™ Interspinous Fusion System can be used to treat a number of prevalent spinal conditions with far less tissue disruption than traditional spinal fixation systems,” states X-spine founder and chief medical officer Dr. David Kirschman. “Today, patients and surgeons are demanding procedures that bridge the gap between non-invasive spine treatment and major procedures such as multiple level spinal fusion. The AXLE™ device addresses that demand in a manner that allows for the implanting surgeon to specifically tailor device components to achieve optimal function.” Dr. Kirschman further states, “An additional benefit of AXLE™ is that by being located on the spinous process, it is situated away from the spinal cord, spinal nerves and large blood vessels. This reduces the possibility of complications related to violation of these structures compared to traditional systems.”
The AXLE™ system is X-spine’s 10th FDA-cleared spinal implant product since 2004. It joins X-spine’s growing portfolio of spinal implant products, including the, Spider Cervical™ Plating System, the X90™ Pedicle Screw System, the Fortex™ Pedicle Screw System, the Calix™ Interbody Fixation System, the Calix ATP™ Vertebral Body Replacement System, the Fixcet™ Spinal Facet Screw System, the Butrex™ Buttress Plating System and the X-PORT™ Minimally Invasive Access System.
May 24, 2010 12:43 PM
X-spine Announces New FDA Clearance of Spinal Implant System
“We are seeing an
evolution to smaller spinal
fixation procedures,
including those being
done on a short patient
stay basis. Being a
minimally invasive facet
system, the Fixcet is ideal
for such procedures
where lumbar fusion
needs to be performed
with minimal tissue
disruption”
MIAMISBURG, Ohio--(BUSINESS WIRE)--X-spine, a global manufacturer of implants and instruments for spinal surgery, announced FDA clearance of its new Fixcet ™ Spinal Facet Screw System. The system is designed to provide spinal stability for lumbar fusion procedures, including the treatment of degenerative disk disease, instability and trauma.
The system incorporates a novel one-piece screw design which provides active compression of the facet joint and improved apposition of the facet surfaces compared to other systems. It can also be inserted through either a traditional open approach or a minimally invasive, wireguided
approach.
“We are seeing an evolution to smaller spinal fixation procedures, including those being done on a short patient stay basis. Being a minimally invasive facet system, the Fixcet is ideal for such procedures where lumbar fusion needs to be performed with minimal tissue disruption,” states X-spine CEO Dr. David Kirschman.
The Fixcet joins X-spine’s growing portfolio of spinal implant products, including the Spider
Cervical™ plating system, the X90™ pedicle screw system, the Fortex™ pedicle screw
system, the Calix ™ interbody fixation system, and the Butrex™ buttress plating system.
About X-spine Systems, Inc.
X-spine (www.x-spine.com) is a global developer and manufacturer of novel technologies for
the treatment of spinal disease. Based in Ohio, privately-held X-spine markets spinal
implants and surgical instruments worldwide for the treatment of spinal degenerative
disease, deformity, trauma, and spinal tumors.
X-spine Announces Exclusive License with Gamma Spine for Minimally-Invasive Spinal Technology
March 8, 2010--X-spine Systems, Inc., a global manufacturer of implants and instruments for spinal surgery, announced today that it has entered into an exclusive license agreement with Gamma Spine for the development and distribution of its minimally invasive spinal fixation technology. Gamma Spine, founded by Dr. Vijay Goel, Ph.D., will participate in the development process with X-spine. "I am thrilled be working with Dr. Goel, who is one of the world's most renowned and published experts in spinal biomechanics, to develop this unique and valuable technology," stated Dr. David Kirschman, President and CEO of X-spine. The patent-pending device allows for the fixation of adjacent vertebral segments with minimal tissue disruption while attaining the biomechanical advantages of a traditional full-exposure system.
"X-spine is the ideal partner to bring this technology to the worldwide marketplace; the company has an excellent track record of bringing innovative technology to fruition through its top-down emphasis on engineering, research, and development," stated Dr. Goel. In addition to his duties as principal of Gamma Spine, Dr. Goel is the Endowed Chair & McMaster-Gardner Professor of Orthopaedic Bioengineering at the University of Toledo, Ohio.
By entering into this license agreement, X-spine furthers its strategy to address the continuing market trend towards smaller, cost-effective procedures in spinal surgery. "Surgeons are demanding procedure options which are less invasive for patients, less costly for payers, but maintain the ease, safety and efficacy of traditional full-exposure procedures," states Dr. Kirschman. "We feel that the Gamma technology effectively addresses that demand."
About X-spine Systems, Inc
Based in Ohio, privately-held X-spine (www.x-spine.com) manufactures and markets implants and instrumentation worldwide for the treatment of a wide range of spinal pathologies. X-spine is an emerging leader in the design and development of novel technologies for the benefit of spinal patients and practitioners.
About Gamma Spine
Based in Toledo, Ohio, Gamma Spine, founded by Vijay Goel, Ph.D., is a developer of proprietary technologies based upon the advanced analysis of spinal biomechanics.
X-spine Announces New FDA Clearance Of Spinal Implant System
Miamisburg, Ohio. — May 4, 2009 —X-spine, an emerging manufacturer of implants and instruments for spinal surgery, announces FDA clearance of its new Calix spinal implant system. The system is designed to function as a cervical intervertebral fixation device as well as a vertebral body replacement device in the thoracic and lumbar spine. The Calix system is manufactured from PEEK-Optima polymer, which enjoys widespread adoption in spinal surgery due to its excellent mechanical and biological properties. The system is X-spine's sixth FDA-cleared spinal product. "We are excited about the Calix because it represents our first product to address cervical interbody fixation," states Dr. David Kirschman, X-spine CEO. "X-spine has earned tremendous growth in the anterior cervical plating market with our Spider Cervical plating system, so the addition of an interbody product to pair with it represents a great opportunity for us." X-spine will introduce the product at the American Association of Neurological Surgeons meeting in San Diego, CA on the 5th of May.
X-spine is an emerging leader in the development and manufacture of novel technologies for the treatment of spinal disease. Based in Ohio, privately-held X-spine markets spinal implants and surgical instruments worldwide for the treatment of spinal degenerative disease, deformity, trauma, and spinal tumors.
Palo Alto, Calif. — March 4, 2008 —Frost & Sullivan recognizes X-Spine Systems, Inc. with the 2008 North American Frost & Sullivan Award for Product Innovation in the field of advanced spinal implantation systems for developing the Capless LI Pedicle Screw system.
This product employs the company’s proprietary Capless screw locking technology that simplifies screw placement by reducing the number of steps during spinal stabilization surgery. It also provides several less invasive options for screw placement and reduces operating and recovery time.
The significance of the Capless LI Pedicle Screw system lies in its unique rotary locking mechanism. “The proprietary rotary locking mechanism incorporated in the screw allows the direct fixation of rod in place, thus doing away with the need for a separate cap or setscrew,” says Frost & Sullivan Research Analyst Prasanna Vadhana Kannan. “In addition to functional benefits for the surgeon, this design results in fewer parts to stock and inventory, in turn leading to significant cost-savings.“
Having been subjected to extensive biomechanical testing, the Capless screw technology offers improved performance over conventional technologies. It is designed to provide a large surface contact area between rod and locking mechanism for greater locking strength. It also includes a flexible crossbar stabilizer that employs a proprietary floating ring that simultaneously locks onto the rod and cross bar, offering improved stability of the overall screw construct. This design also eliminates the possibility for undesired cap loosening, cap loss or difficulties in cap placement.
Since receiving clearance from the FDA in September 2007, the Capless LI Pedicle Screw system has undergone over 200 implantations. The company hopes to build upon the successful Capless product platform to increase indications and exposure in the minimally invasive, deformity, and dynamic fixation markets.
“The company is also investing in the development of a disk augmentation system, which will improve the function and reduce the pain associated with degenerative disk disease of the lumbar spine, without destruction of underlying anatomy,” notes Prasanna. “Recently, X-Spine received FDA clearance for the Butrex buttress plating system, which provides an implant option for the front of the spine and is intended to be used along with the Capless LI Pedicle Screw system.”
Apart from the two issued patents and multiple patents pending in the spinal fixation market, X-Spine Systems has five FDA-approved products in the United States and two with CE mark for Europe. The company has also granted several licensing and/or distribution agreements for its proprietary technology to other important market participants.
Each year Frost & Sullivan presents this Award to the company that has demonstrated excellence in new products and technologies within its industry. The recipient company has shown innovation by launching a broad line of emerging products and technologies.
Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
About X-Spine Systems, Inc.
Based in Ohio, X-Spine Systems, Inc. is a privately-held corporation dedicated to developing next-generation spinal implants that improve spinal surgery outcomes and optimize surgeon experience.
About Frost & Sullivan
Frost & Sullivan, the Global Growth Consulting Company, partners with clients to accelerate their growth. The company's Growth Partnership Services, Growth Consulting and Career Best Practices empower clients to create a growth-focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents. For more information, visit http://www.awards.frost.com.
X-spine Announces FDA Clearance for New Spinal System
January 30, 2008--X-spine Systems, Inc., a leading developer and manufacturer of spinal implant systems, announced today that it had obtained FDA clearance to market its new BUTREX™ Buttress Plating System. The system builds upon X-spine’s growing lineup of spinal fixation technology by offering a compact titanium alloy plate for the buttressing of an anterior lumbosacral intervertebral bone graft. The BUTREX™ utilizes X-spine’s patented resilient-arm screw locking technology to prevent screw dislodgement from the buttress plate. “The BUTREX™ brings additional confidence to ALIF procedures by significantly reducing the potential for anterior expulsion of the interbody bone graft.” states David Kirschman, M.D., Chief Medical Officer of X-spine. “When used with supplemental posterior instrumentation, such as the X-spine CAPLESS® pedicle screw systems, the BUTREX™ adds stability and security to ALIF procedures.” The BUTREX™ system includes a comprehensive set of placement instrumentation designed for the unique exposure challenges of the anterior lumbosacral spine. Based in Miamisburg, Ohio, privately-held X-spine Systems, Inc. is an emerging leader in the development of propriety technology for the international spinal surgery industry.
