The design goals for DSS included allowing more natural kinematics, but only in a neutral or ‘safe’ zone. For most of us, pain is generated when we weight the disc, or when we overload portions of the system by venturing into more extreme ranges of motion. (Bending, lifting, twisting.) If natural kinematics are maintained, but motion is maintained with the neutral zone, the system stays in the ‘safe’ range.
The DSS system is a modular design that includes the ‘soft’ module that provides flexibility not only in flexion and extension, but also in lateral bending. Allowing expansion in flexion and compression in extension, compound movements and lateral bending produces more normal kinematics than does Dynesys. This ‘softer’ system should provide reduced loading on adjacent segments compared to Dynesys and also reduced loading on the screws.
One of the most important features of DSS is the modular design. In addition to the flexible spacers, the DSS system includes rigid spacers for traditional fusion. With this modular system, multi-level procedures can easily mix fusion and soft stabilization. More importantly, if the soft stabilization must ultimately be revised to fusion, a small procedure to remove the flexible spacers and replace them with rigid ones will be all that is necessary. The screws… the other levels can all be left alone… just replace the appropriate segments. The easy revision promised for Dynesys is great in theory… not in practice.
Paradigm Spine, LLC, a developer of innovative non-fusion spinal implant solutions, announced that it has received a European Union CE Mark for its DSSTM implantable dynamic spine stabilization system. The CE Mark will allow the company to begin marketing the DSSTM system in Europe and many other countries that recognize the certification.
The first surgery involving the DSSTM system was performed on April 27th, 2007 in Straubing, Germany by Dr. Rudolf Bertagnoli.
The DSSTM system is a pedicle-screw based, implantable dynamic spine stabilization system indicated for degenerative disc disease (DDD) of the lumbar spine. The DSSTM system incorporates a hybrid philosophy, combining elements of fusion and motion preservation.
The system was developed over a two-year period in close cooperation with Professor Hans- Joachim Wilke, a world-renowned Professor of Biomechanics from the University of Ulm in Germany, and Dr. Bertagnoli, the most experienced spine arthroplasty surgeon worldwide.
The modularity of the DSSTM system enables the combination of DSS dynamic couplers with DSS fusion couplers at adjacent levels. Therefore, one segment may have functionally dynamic stabilization (non-fusion) while an adjacent segment has rigid segmental fixation (fusion) under the same system.
The DSS dynamic coupler increases the stiffness of the affected motion segment and restricts the range of motion in flexion, extension, lateral bending and rotation while preserving motion. By selecting the appropriate size DSS dynamic coupler, the posterior segmental height can also be adjusted. The DSS fusion coupler provides rigid segmental fixation utilizing the same instrument set. One of the features and benefits of the system is the use of percutaneous screw
positioning that facilitates a minimally invasive muscle-sparing approach.
Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said, “The DSSTM system is the product of collaborative thinking between two of the world’s most experienced spine motion- preserving experts, from both a scientific and clinical point-of-view.”
“The DSSTM system is one of the first truly dynamic stabilization systems because it increases segmental stiffness while controlling specific ranges of motion as the patient goes about his or her daily activities,” he noted. “We are particularly excited to have benefited from the enthusiastic development efforts and significant contributions of Professor Wilke and Dr. Bertagnoli.”
Professor Wilke said, “I worked very closely with the Company on incorporating the key strategic and scientific elements of the ranges and types of motion which need to be controlled by a true dynamic stabilization system. Specifically, we designed the system to focus on controlling ‘active zone’ motions, which are normally associated with pathologic painful arcs of motion.”
Professor Wilke further added, “This product reflects what we have learned about the function of the human spine from multiple spine experiments over many years, based on studies conducted with our validated Finite Element model of a lumbar spinal segment.”
Dr. Bertagnoli said, “The surgery on Friday [April 27] went very well and I believe the DSSTM system has the potential to become an important new option in the continuum of spine care.
Having used most of the major spine arthroplasty products I, like Professor Wilke, am convinced of the uniqueness and potential impact of the DSSTM system for the treatment of my patients.”
The DSSTM system is Paradigm Spine’s fourth product to receive a CE Mark, following the coflex® interspinous implant, the DCITM dynamic cervical implant, which received the CE Mark on December 5, 2006; and the coflex-FTM implant system which received the CE Mark on December 15, 2006.
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( 3 / 116 )Fuente:
Colegio Oficial de Médicos de Málaga- España
RETIRADA DEL MERCADO DE TODOS LOS LOTES DE LOS DISPOSITIVOS DE ESTABILIZACIÓN DINÁMICA CD HORION AGILE
25-01-2008
ASUNTO: Retirada del mercado de todos los lotes de los Dispositivos de estabilización dinámica CD Horizon Agile Ref.: 7880600 a la 7881590 y Ref.: 7900600 a la 7901590, fabricados por Medtronic Spinal y Biologics, EEUU y seguimiento de los pacientes implantados.
PRODUCTOS AFECTADOS: Todos los lotes de los Dispositivos de estabilización dinámica CD Horizon Agile Ref.: 7880600 a la 7881590 y Ref.: 7900600 a la 7901590, fabricados por Medtronic Spinal y Biologics, EEUU.
Números de referencia afectados:
7900600, 7900610, 7900620, 7900635, 7900640, 7900645, 7900650, 7900651, 7900655, 7900660, 7900670,
7900680, 7900690, 7901000, 7901010, 7901020, 7901040, 7901045, 7901050, 7901060, 7901070, 7901080,
7901090, 7901500, 7901510, 7901520, 7901545, 7901550, 7901560, 7901570, 7901580, 7901590, 7880600,
7880610, 7880620, 7880635, 7880640, 7880645, 7880650, 7880651, 7880655, 7880660, 7880670, 7880680,
7880690, 7881000, 7881010, 7881020, 7881040, 7881045, 7881050, 7881060, 7881070, 7881080, 7881090,
7881500, 7881510, 7881520, 7881545, 7881550, 7881560, 7881570, 7881580, 7881590.
MENSAJE:
Se ha recibido en la Unidad de Vigilancia de Productos Sanitarios de la Agencia Española de Medicamentos y Productos Sanitarios comunicación de la empresa Medtronic Iberica S.A, sita en C/ María de Portugal, 11, 28050, Madrid, relacionada con la retirada del mercado de todos los lotes de los Dispositivos de estabilización dinámica CD Horizon Agile Ref.: 7880600 a la 7881590 y Ref.: 7900600 a la 7901590, fabricados por Medtronic Spinal y Biologics, EEUU y el seguimiento de los pacientes implantados con estos dispositivos. CD Horizon Agile es un dispositivo implantable que se suministra estéril. El dispositivo de estabilización dinámica CD Horizon Agile está diseñado para ayudar a inmovilizar y estabilizar los segmentos de la columna vertebral a la altura torácica, lumbar y/o sacra. El dispositivo consiste en una barra de 5,5 mm de diámetro, un cable y un espaciador que son suministrados en una gran variedad de formas, tamaños y longitudes de barra.
Medtronic ha detectado que los dispositivos pueden presentar fallos si no se utilizan de manera adecuada. Un mayor riesgo está asociado con el grado de inestabilidad, tanto si era pre-existente como producida a causa de la cirugía. Las roturas del cable del sistema de estabilización pueden darse como consecuencia de acontecimientos traumáticos tales como caídas o en caso de situaciones extremas, las cuales incluyen, pero no se limitan a las siguientes:
- Uso en enfermedad traslacional activa en forma de espondilolistesia muy inestable
- Deformidades angulares (tales como el apex de la curva de una escoliosis)
- Colocación inadecuada del tornillo y una mala técnica de ajuste de la barra.
De acuerdo con la información facilitada por la empresa, estas situaciones han dado lugar a casos de fallo por rotura del cable del sistema de estabilización dinámica CD Horizon Agile. Cuando esto ocurre, la alteración es visible mediante rayos X durante un chequeo de rutina. Esta rotura del cable puede que no produzca ningún problema, o puede ser que produzca daños que pueden ser visibles a corto o a largo plazo. Estos problemas incluyen una vuelta a los síntomas (dolor en la pierna y/o en la espalda), o irritación local del tejido debido al desplazamiento de los componentes. Si no se realiza una intervención para revisarlo, existe la posibilidad de que la degeneración progrese hasta necesitar tratamiento o que aparezca una reacción potencial debido a un exceso de partículas de desgaste.
Medtronic recomienda una monitorización de los pacientes a los que se les ha implantado un dispositivo de estabilización dinámica CD Horizon Agile para descubrir síntomas no esperados por el procedimiento, tales como un aumento del dolor o cualquier cambio imprevisto en sus síntomas clínicos..
Si se descubre un cable roto durante el seguimiento, se debe continuar monitorizando al paciente para evaluar los síntomas clínicos que pueden atribuirse probablemente al fallo del dispositivo. En esos casos, según el criterio del medico, el riesgo de dejar el dispositivo implantado puede ser menor que el riesgo de explantarlo, sugiriéndose solamente una observación. Si el paciente tiene síntomas significativos de manera repentina, puede considerarse la opción de utilizar una barra más rígida. En ultimo caso, el medico debería elegir la mejor opción terapéutica para asegurar el mejor resultado en cuanto a seguridad y efectividad para el paciente.
La empresa ha enviado una Nota de aviso informando de la retirada a los centros que disponen del producto afectado, en la que se incluyen las recomendaciones y actuaciones a seguir por cada uno de los centros.
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( 3 / 143 )
Aladyn™ like Isobar® is indicated for disorders of the lumbar spine.
The Isobar® TTL system is versatile and apart from it's use as a low back system is equally suited for use in the thoraco-lumbar spine in tumour/trauma and deformity.
The SCIENT'X range of dynamic semi-rigid pedicle screw systems offers the following key benefits: -
Prevention of adjacent segment degeneration
Reduction of implant breakage
Improved quality of the interbody fusion
Potential use as a non-fusion device
- On one side, a rigid connecting element /on the other side, a semi-rigid connecting
element
- On one side, a semi-rigid connecting element/ on the other side a different semi rigid
connecting element from another range of products
- On one side, a rigid connecting element/
Aladyn3’s kit is a hybrid system. This is an efficient way,
on one hand, to deal with a diseased segment which
should not fuse or when this segment is not yet
diagnosed as symptomatic. And on the other hand, it
allows to operate on an adjacent segment that needs
to fuse.
Furthermore, it is the only true hybrid system with an
optimum instrumentation which is relatively
convenient to use. And I obtained good results with
this system.
In my opinion, the principal benefit of Aladyn3 is the
dynamic plate. Indeed, this plate has an integrated
shock absorber which creates a transitional zone to
prevent adjacent segment degeneration.
For which indications would you recommend to
use Aladyn3?
The best indication would be for a young patient with
lytic spondylolisthesis with an adjacent black disc.
If you do not use the dynamic plate, indications are the
same as for a lumbar spinal fusion.
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The coflex(TM) device is a U-shaped titanium alloy, available in 5 sizes from 8mm to 16mm. It is indicated for use in patients with radiographically confirmed moderate to severe stenosis with neural element compromise resulting in claudication and/or radicular symptoms isolated to 1 or 2 levels, in the region of L1 to L5.
The company's founding philosophy is "Surgeon Centric, Indication Specific, Data Driven", and focuses on providing the best clinical outcomes for patients suffering from chronic back pain. The company is concentrating on building a multi-product non-fusion portfolio. One product is the coflex(TM) device, a posterior non-fusion interspinous dynamically-functional implant, which has a long clinical history of over a decade of use and has been implanted in more than 15,000 patients suffering from low back pain and lumbar spinal stenosis.
Paradigm Spine, LLC
http://www.paradigmspine.com
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( 3 / 159 )
Gunze was the first company in the world to successfully commercialize a bioabsorbable artificial dural substitute.
This product was released in the European market in October 2005.
http://www.gunze.co.jp/e/medical/produc ... l#seamdura
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