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News Article | February 28, 2017
Site: www.businesswire.com

« Lorsqu'il s'agit de sélectionner la meilleure stratégie de greffe osseuse pour chaque patient, les chirurgiens peuvent choisir parmi de nombreuses options. BIOSPHERE PUTTY est une solution de greffe osseuse élégante qui est basée sur des principes scientifiquement valables », a déclaré Erik Westerlund MD, FACS, directeur du programme Ortho-Neuro Integrated Spine Surgery Program au St. Francis Hospital, aux États-Unis. « Il applique des connaissances avancées et pointues du verre bioactif en vue de stimuler une réaction ciblée au niveau cellulaire et de procurer un environnement physique idéal favorable à une régénération osseuse prévisible. Mon expérience clinique de BIOSPHERE PUTTY au cours des deux dernières années est excellente. J'obtiens régulièrement de bons résultats à long terme, dans une vaste gamme d'applications rachidiennes. C'est une solution osseuse extrêmement bien conçue et tout aussi polyvalente. » Fondée en 2011, Synergy Biomedical est une société privée de fabrication de dispositifs médicaux, spécialisée dans les produits innovateurs à base de biomatériaux pour les applications orthopédiques et rachidiennes. La technologie BioSphere de la société représente une approche unique visant à faire progresser la technologie en matière de greffe osseuse et à améliorer la guérison osseuse et les résultats pour le patient.


News Article | February 28, 2017
Site: www.businesswire.com

BIOSPHERE PUTTY, dat oorspronkelijk in 2013 in de VS is geïntroduceerd, is een synthetisch bottransplantatieproduct dat gebruik maakt van bioactief glas in een unieke vorm, in combinatie met een kneedbare fosfolipide-drager. BIOSPHERE PUTTY is gebaseerd op de gepatenteerde BioSphere-technologie van het bedrijf. Het is in vivo aangetoond dat de bolvorm en de geoptimaliseerde, bimodale groottes van de bioactieve glasdeeltjes het herstelvermogen van het materiaal significant verbeteren. “BIOSPHERE PUTTY is sinds de introductie heel goed ontvangen door chirurgen, vanwege het succesvolle klinische gebruik en de uitstekende hanteerbaarheid tijdens het opereren,” verklaarde dr. Mark Borden, Ph.D., President/CEO of Synergy. “We zijn blij met onze CE-markering en zien ernaar uit dit synthetische bottransplantatieproduct van een werkelijk nieuwe generatie te introduceren in de Europese Gemeenschap.” BIOSPHERE PUTTY is in Europa goedgekeurd voor gebruik als bottransplantatiemateriaal voor het opvullen van botholtes of leemtes van het skelet. Dit omvat het gebruik van het product voor interbody- en posterolaterale fusie en als algemene vulling bij botdefecten in de ledematen en het bekken. Het product kan alleen of in combinatie met autogene of allogene transplantaten worden gebruikt . “Bij het kiezen van de beste bottransplantatiestrategie voor elke patiënt zijn er tal van opties voor chirurgen. BIOSPHERE PUTTY is een elegante oplossing voor bottransplantaties op basis van wetenschappelijk aanvaarde principes,” aldus Erik Westerlund MD, FACS, Director Ortho-Neuro Integrated Spine Surgery Program van het St. Francis Hospital in de VS. “Dankzij een diep en geavanceerd inzicht in bioactief glas wordt een doelbewuste respons op celniveau teweeggebracht en een ideale fysieke omgeving gecreëerd voor een gelijkmatige en voorspelbare botingroei. Mijn klinische ervaring met BIOSPHERE PUTTY in de afgelopen twee jaar is uitstekend, met succesvolle langetermijnresultaten in zeer uiteenlopende toepassingen in de wervelkolom. Het is een uiterst doordachte en veelzijdige oplossing voor bottransplantaties.” BIOSPHERE PUTTY is de eerste in een reeks door Synergy Biomedical te ontwikkelen bottransplantatieproducten die gebruik maken van gepatenteerde bolvormige deeltjes bioactief glas waarvan is aangetoond dat ze het herstelvermogen van het materiaal verbeteren. BIOSPHERE PUTTY biedt chirurgen een kneedbaar bottransplantatiemateriaal dat gemakkelijk te gebruiken is en geschikt is voor zeer uiteenlopende bottransplantatietechnieken. Synergy Biomedical is opgericht in 2011. Het is een particuliere onderneming in medische hulpmiddelen die zich richt op de ontwikkeling van innovatieve producten op basis van biomaterialen voor orthopedische en wervelkolomchirurgie. Met de BioSphere-technologie brengt het bedrijf de bottransplantatietechniek op unieke wijze naar een hoger plan en draagt het bij aan verbetering van de genezing van botten en de resultaten voor patiënten. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.


News Article | February 28, 2017
Site: www.businesswire.com

COLLEGEVILLE, Pennsylvania--(BUSINESS WIRE)--Synergy Biomedical, LLC, un'azienda che si occupa dello svilupo di prodotti innovativi per l'innesto osseo in ambito di interventi chirugici vertebrali e ortopedici, ha annunciato in data odierna di aver ricevuto l'autorizzazione CE nell'Unione Europea per il suo innesto osseo di prossima generazione: BIOSPHERE PUTTY. In base all'autorizzazione ricevuta dalla CE, l'utilizzo di BIOSPHERE PUTTY è inteso per l'innesto osseo volto a riempire cavità ossee nel sistema scheletrico. Ciò comprende l'utilizzo del prodotto per fusione intersomatica o postero-laterale e riempimento di difetti ossei generici nelle estremità e nell'area pelvica. Il prodotto può essere utilizzato da solo o unitamente ad auto o allotrapianto. “Quando si tratta di selezionare la migliore strategia per l'innesto osseo di un determinato paziente, i chirurghi hanno a disposizione una vasta gamma di opzioni. BIOSPHERE PUTTY è una soluzione elegante per l'innesto osseo basata su principi scientificamente validi", ha commentato Erik Westerlund MD, FACS, direttore dell'Ortho-Neuro Integrated Spine Surgery Program presso il St. Francis Hospital negli USA. “Applica una comprensione avanzata e raffinata del vetro bioattivo per sollecitare una risposta cellulare in maniera mirata e per fornire l'ambiente fisico ideale alla ricrescita uniforme e prevedibile dell'osso. La mia esperienza clinica con BIOSPHERE PUTTY negli ultimi due anni è stata eccellente, con risultati di successo a lungo termine e costanti in un'ampia gamma di applicazioni vertebrali. Si tratta di una soluzione per l'innesto osseo estremamente efficace e versatile". BIOSPHERE PUTTY è il primo di diversi prodotti per l'innesto osseo sviluppati da Synergy Biomedical che utilizzano sfere di vetro bioattivo brevettate dal comprovato potenziale terapeutico del vetro bioattivo. BIOSPHERE PUTTY offre ai chirurghi un materiale modellabile per l'innesto osseo facile da utilizzare e compatibile con una varietà di tecniche per gli innesti ossei.


News Article | February 28, 2017
Site: www.businesswire.com

COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced today that it has received CE Mark clearance in the European Union for its next generation bone graft, BIOSPHERE PUTTY. Originally launched in the U.S. in 2013, BIOSPHERE PUTTY is a synthetic bone graft product that utilizes a unique form of bioactive glass in combination with a moldable phospholipid carrier. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass due to its spherical particle shape and optimized, bimodal size range. “Since its introduction, BIOSPHERE PUTTY has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “We are very pleased to receive our CE Mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.” Under its cleared European indication, BIOSPHERE PUTTY is intended to be used as a bone graft material for filling bony voids or gaps of the skeletal system. This includes the use of the product for interbody and posterolateral fusion, and general bone defect filling in the extremities and pelvis. The product may be used alone or in combination with autograft or allograft. “When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BIOSPHERE PUTTY is an elegant bone graft solution that is based on scientifically valid principles,” said Erik Westerlund MD, FACS, Director of the Ortho-Neuro Integrated Spine Surgery Program at St. Francis Hospital in the U.S. “It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone ingrowth. My clinical experience with BIOSPHERE PUTTY over the past two years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution.” BIOSPHERE PUTTY is the first of several bone graft products being developed by Synergy Biomedical that utilize patented bioactive glass spheres that have been shown to improve the bone healing potential of bioactive glass. BIOSPHERE PUTTY provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques. Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial based products to the orthopaedic and spinal markets. The Company’s BioSphere Technology represents a unique approach to advancing bone graft technology, and improving bone healing and patient outcomes.


Alcaraz R.,University of Castilla - La Mancha | Rieta J.J.,Synergy Biomedical
Nonlinear Analysis: Real World Applications | Year: 2010

Nowadays, several non-linear regularity estimators have been successfully applied to invasive atrial electrograms in order to characterize the atrial electrical activity organization during atrial fibrillation (AF). This arrhythmia is the most common encountered in clinical practice, accounting for approximately one-third of all the hospitalizations for cardiac rhythm disturbances. However, from a clinical point of view, it would be more desired to evaluate atrial activity (AA) organization from surface electrocardiographic (ECG) recordings, since they can be obtained easily and cheaply and the risks associated with invasive recordings could be avoided. In this work, Sample Entropy (SampEn) is proposed to assess the organization degree of the AA obtained from surface ECGs. To this respect, a reliable and non-invasive organization estimator would allow the prediction of spontaneous AF termination, since invasive studies have shown more organized electrical activity signals during the preceding instants of AF termination. The proposed method computed SampEn over the AA obtained from TQ segments, free of QRST complexes, and was validated with a database containing a training set of 20 AF recordings, with known termination properties, and a test set of 30 recordings. A simulation study showed that patients with heart rates of 130 bpm and above must be handled with care, because TQ intervals could be considerably reduced (<50 ms). As an overall result, spontaneous AF termination in 90% of the learning and test recordings was correctly predicted through this novel approach. As a conclusion, this work introduces the application of a non-linear regularity index able to assess significative differences in AA organization from surface ECG recordings during AF. © 2009 Elsevier Ltd. All rights reserved.


Alcaraz R.,University of Castilla - La Mancha | Rieta J.J.,Synergy Biomedical
Biomedical Signal Processing and Control | Year: 2010

The application of non-linear metrics to physiological signals is a valuable tool because "hidden information" related to underlying mechanisms can be obtained. In this respect, approximate entropy (ApEn) is the most popular non-linear regularity index that has been applied to physiological time series. However, ApEn presents some shortcomings, such as bias, relative inconsistency and dependence on the sample length. A modification of ApEn, named sample entropy (SampEn), was introduced to overcome these deficiencies. Recently, in the context of electrocardiography, SampEn has been applied to study non-invasively atrial fibrillation (AF), which is the most common arrhythmia encountered in clinical practice with unknown mechanisms provoking its onset and termination. Useful clinical information, that could help for a better understanding of AF mechanisms, has been obtained through the application of SampEn to electrocardiographic (ECG) recordings. This work reviews its application in the context of non-invasive analysis of AF. During this arrhythmia, atrial and ventricular components can be regarded as unsynchronized activities, whereby, the application of SampEn to the analysis of each component will be described separately. In first place, clinical challenges in which SampEn has been successfully applied to estimate AF organization from the atrial activity pattern are presented. The AF organization study can provide information on the number of active reentries, which can help to improve AF treatment and to take the appropriate decisions on its management. Next, the heart rate variability study via SampEn, to characterize ventricular response and predict AF onset, is described. Through the aforementioned applications it is remarked throughout this review that SampEn can be considered as a very promising and useful tool towards the non-invasive understanding of AF. © 2009 Elsevier Ltd. All rights reserved.


Alcaraz R.,University of Castilla - La Mancha | Rieta J.J.,Synergy Biomedical
Physiological Measurement | Year: 2010

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice. In the first stages of the disease, AF may terminate spontaneously and it is referred to as paroxysmal AF. The arrhythmia is called persistent AF when external intervention is required to its termination. In the present work, a method to non-invasively assess AF organization has been applied to discern between paroxysmal and persistent AF episodes at any time. Previous works have suggested that the probability of AF termination is inversely related to the number of reentries wandering throughout the atrial tissue. Given that it has also been hypothesized that the number of reentries is directly correlated with AF organization, a fast and robust method able to assess organization differences in AF could be of great interest. In fact, the distinction between paroxysmal and persistent episodes in patients without previously known AF history, making use of short ECG recordings, could contribute to taking earlier decisions on AF management in daily clinical practice, without the need to require 24 h or 48 h Holter recordings. The method was based on a nonlinear regularity index, such as sample entropy (SampEn), and evidenced to be a significant discriminator of the AF type. Its diagnostic accuracy of 91.80% was demonstrated to be superior to previously proposed parameters, such as dominant atrial frequency (DAF) and fibrillatory waves amplitude, and to others analyzed for the first time in this context, such as atrial activity mean power, 3 dB bandwidth around the DAF, first harmonic frequency, harmonic exponential decay, etc. Additionally, according to previous invasive works, paroxysmal AF episodes (0.0716 0.0143) presented lower SampEn values and, consequently, more organized activity, than persistent episodes (0.1080 0.0145). © 2010 Institute of Physics and Engineering in Medicine.


Mateo J.,University of Castilla - La Mancha | Joaquin Rieta J.,Synergy Biomedical
Computers in Biology and Medicine | Year: 2013

The most extended noninvasive technique for medical diagnosis and analysis of atrial fibrillation (AF) relies on the surface elctrocardiogram (ECG). In order to take optimal profit of the ECG in the study of AF, it is mandatory to separate the atrial activity (AA) from other cardioelectric signals. Traditionally, template matching and subtraction (TMS) has been the most widely used technique for single-lead ECGs, whereas multi-lead ECGs have been addressed through statistical signal processing techniques, like independent component analysis. In this contribution, a new QRST cancellation method based on a radial basis function (RBF) neural network is proposed. The system is able to provide efficient QRST cancellation and can be applied both to single and multi-lead ECG recordings. The learning algorithm used for training the RBF makes use of a special class of network, known as cosine RBF, by updating selected adjustable parameters to minimize the class-conditional variances at the outputs of the network. The experiments verify that RBFs trained by the proposed learning algorithm are capable of reducing the QRST complex dramatically, a property that is not shared by other methods and conventional feed-forward neural networks. Average Results (mean ± std) for the RBF method in cross-correlation (CC) between original and estimated AA are CC. =. 0.95. ±. 0.038 being the mean square error (MSE) for the same signals, MSE. =. 0.311. ±. 0.078. Regarding spectral parameters, the dominant amplitude (DA) and the mean power spectral (MP) were DA. =. 1.15. ±. 0.18 and MP. =. 0.31. ±. 0.07, respectively. In contrast, traditional TMS-based methods yielded, for the best case, CC. =. 0.864. ±. 0.041, MSE. =. 0.577. ±. 0.097, DA. =. 0.84. ±. 0.25 and MP. =. 0.24. ±. 0.07. The results prove that the RBF based method is able to obtain a remarkable reduction of ventricular activity and a very accurate preservation of the AA, thus providing high quality dissociation between atrial and ventricular activities in AF recordings. © 2012 Elsevier Ltd.


News Article | March 1, 2017
Site: www.businesswire.com

COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, desarrollador de innovadores productos óseos para cirugía medular y ortopédica, ha anunciado que ha recibido la aprobación del marcado CE en la Unión Europea para su próxima generación de injertos óseos, BIOSPHERE PUTTY. Lanzado originalmente en Estados Unidos en 2013, BIOSPHERE PUTTY es un producto de injerto óseo sintético que utiliza una forma única de vidrio bioactivo en combinación con un portador fosfolípido moldeable. Basado en

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