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Spoločnosť Synapse Biomedical získava núdzové povolenie od FDA na nový systém asistencie pacientom, ktorí sú odstavovaní od ventilátorov počas pandémie infekcie COVID-19
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News provided by

Synapse Biomedical, Inc.

Apr 15, 2020, 06:00 ET

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Diafragmatická stimulácia (DPS) TransAeris® by dokázala skrátiť čas mechanickej ventilácie o viac ako 25%, čo by znamenalo uvoľnenie zásadných prístrojov, akútnych lôžok a klinických zdrojov. 

OBERLIN, Ohio, 15. apríla 2020 /PRNewswire/ -- Synapse Biomedical, Inc. (www.synapsebiomedical.com) získal núdzové povolenie od FDA na použitie nového DPS systému TransAeris® asistujúceho pacientom pri odstavovaní od ventilátorov v prípadoch, u ktorých poskytovateľ zdravotnej pomoci identifikuje vysoké riziko zlyhania po odstavení od ventilátora v nemocničnom prostredí počas pandémie infekcie COVID-19 po dobu nie viac ako 30 dní.

Viac informácií získate na webovej stránke: www.synapsebiomedical.com/covid-19 

The TransAeris system addresses this issue by conditioning a patient’s diaphragm to reduce/avoid VIDD. Models suggest the technology--which recently received CE Mark approval and is under clinical investigation in the U.S - could reduce ventilator burden in COVID-19 patients by 26 percent, helping to free up more ventilators in a time of great demand.
The TransAeris system addresses this issue by conditioning a patient’s diaphragm to reduce/avoid VIDD. Models suggest the technology--which recently received CE Mark approval and is under clinical investigation in the U.S - could reduce ventilator burden in COVID-19 patients by 26 percent, helping to free up more ventilators in a time of great demand.

Počas pandémie infekcie COVID-19 sú nemocnice a jednotky intenzívnej starostlivosti vystavené bezprecedentnému prírastku pacientov vyžadujúcich prolongovanú pľúcnu ventiláciu (PMV). Aj v štádiách, keď sú primárne príznaky u pacientov stabilizované, je stále prítomné riziko vyvinutia ventilátorom indukovanej diafragmatickej dysfunkcie (VIDD), čo predlžuje čas nevyhnutnej ventilácie.

Systém TransAeris rieši práve tento problém stimuláciou bránice pacienta, čím predchádza alebo znižuje riziko VIDD. Z modelov vyplýva, že technológia, ktorá nedávno získala označenie CE a v USA prebieha jej klinické testovanie, by mohla znížiť tlak na využívanie ventilátorov u pacientov s infekciou COVID-19 o 26 percent, čo znamená uvoľnenie väčšieho počtu ventilátorov v čase ich nedostatku.

„Celosvetovo bolo pomocou technológií stimulujúcich činnosť bránice úspešne liečených viac ako 2 000 pacientov," hovorí Anthony Ignagni, prezident a generálny riaditeľ spoločnosti Synapse Biomedical. „Sme veľmi radi, že sa FDA chopila tejto iniciatívy a ponúka toto núdzové riešenie. Lekári tak môžu využívať našu najnovšiu technológiu TransAeris a pomáhať čo najväčšiemu počtu pacientov s infekciou COVID-19 počas pandémie."

„Vysokorizikoví pacienti na chirurgii, traumatológii a pacienti s kardiovaskulárnymi ochoreniami  budú musieť zostať ležať na jednotkách intenzívnej starostlivosti a budú naďalej potrebovať ventilátory, ktoré sú potrebné aj pre pacientov s infekciou COVID-19," hovorí MUDr. Raymond P. Onders, FACS, primár všeobecnej chirurgie, zdravotníckeho strediska fakultnej nemocnice v Clevelande a profesor na lekárskej fakulte Case Western Reserve University. „V našom prípade znamená použitie systému TransAeris u vysokorizikových pacientov na chirurgii a s infekciou COVID-19 ochranu zásob ventilátorov, akútnych lôžok a klinických zdrojov tým, že skrátime čas strávený na mechanickej ventilácii u rizikových pacientov alebo tých, u ktorých sa predlžuje čas potrebnej pľúcnej ventilácie."

TransAeris builds nadväzuje na úspech predchádzajúcej technológie diafragmatickej stimulácie spoločnosti Synapse Biomedical pod názvom NeuRx®, ktorá získala povolenie od FDA a označenie CE už v roku 2008 pre pacientov s poranením miechy a úspešne znížila alebo eliminovala potrebu mechanickej pľúcnej ventilácie. TransAeris vznikol ako asistencia pacientom s prolongovanou mechanickou pľúcnou ventiláciou na dočasnej báze do 30 dní. Oproti predchádzajúcemu systému stimulácie bránice NeuRx DPS predstavuje zjednodušenie v podobe jednorazového zariadenia, ktoré umožňuje použitie u jedného pacienta po dobu 30 dní. TransAeris už úspešne využilo niekoľko centier v Európe, vrátane BGU Murnau (Nemecko) pri akútnych poraneniach miechy a pri polytraumatických pacientoch.

O spoločnosti Synapse Biomedical, Inc.: Spoločnosť Synapse Biomedical bola založená v roku 2002 ako vedľajší podnik Univerzity Case Western Reserve a univerzitných nemocníc v Clevelande, s cieľom poskytovať liečbu transformujúcu životy pacientov prostredníctvom komercializácie neurostimulačných platforiem a vybudovať udržateľný podnik na základe vedeckých a klinických poznatkov, ktoré poskytnú zmysluplnú hodnotu pacientom, zamestnancom, komunite a akcionárom. Synapse má ústredie v Oberlin v štáte Ohio a svoju európsku pobočku má v Enghien les Bains vo Francúzsku. Viac informácií nájdete na webovej stránke: www.synapsebiomedical.com.

The TransAeris® Diaphragm Pacing System (DPS) nebol schválený ani povolený pre indikáciu asistencie pacientom, ktorí sú odstavovaní od ventilátorov v zdravotníckych zariadeniach počas pandémie infekcie COVID-19. TransAeris DPS bol povolený pre vyššie uvedené núdzové použitie zo strany FDA v rámci EUA. TransAeris DPS bol schválený na použitie len po dobu prítomnosti zjavných okolností odôvodňujúcich povolenie núdzového použitia TransAeris DPS podľa §564(b)(1) Zákona, 21 U.S.C. § 360bbb-3(b)(1), pokiaľ nie je povolenie ukončené alebo odňaté skôr. 

Foto - https://mma.prnewswire.com/media/1155320/Synapse_Biomedical_Transaeris_System.jpg

Related Links

http://www.synapsebiomedical.com

SOURCE Synapse Biomedical, Inc.

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