{"id":393320,"date":"2021-05-13T16:48:19","date_gmt":"2021-05-13T19:48:19","guid":{"rendered":"https:\/\/revistapesquisa.fapesp.br\/?p=393320"},"modified":"2021-05-13T16:48:19","modified_gmt":"2021-05-13T19:48:19","slug":"life-support","status":"publish","type":"post","link":"https:\/\/revistapesquisa.fapesp.br\/en\/life-support\/","title":{"rendered":"Life support"},"content":{"rendered":"
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Caroline Bianchini\u2009\/\u2009Braile Biom\u00e9dica<\/span><\/a> The Solis system from Braile Biom\u00e9dica: the machine serves as an artificial lung and heart for critically ill patientsCaroline Bianchini\u2009\/\u2009Braile Biom\u00e9dica<\/span><\/p><\/div>\n

Braile Biom\u00e9dica, a Brazilian firm that has pioneered the development of medical equipment for cardiology, recently launched a high-complexity device that can help treat patients suffering from acute respiratory failure, a common complication in severe cases of COVID-19. The system, dubbed Solis, is designed for a type of therapy known in the medical field by the acronym ECMO, or Extracorporeal Membrane Oxygenation. The device supports out-of-body breathing as a last resort when mechanical ventilators have failed to help.<\/p>\n

\u201cIt functions as an artificial lung and can be used in both adults and children,\u201d explains Rafael Braile, operations and research and development director at the Brazilian manufacturer, based in S\u00e3o Jos\u00e9 do Rio Preto (SP), southeastern Brazil. \u201cThe machine pumps blood from the patient\u2019s body via catheters, adds oxygen to it using a polymeric membrane, then sends the blood back to the patient. It\u2019s an invasive life-support treatment that can help keep patients alive until their lungs recover.\u201d ECMO machines can also be used temporarily as an artificial heart by patients who have had a heart transplant, a heart attack or cardiac arrest.<\/p>\n

Braile Biom\u00e9dica developed the system in less than a year with technical support from the Eldorado Research Institute in Campinas (SP), run by the Brazilian Agency for Industrial Research and Innovation (EMBRAPII). The project received total funding of R$7.8 million, including R$2.3 million paid in equal parts by EMBRAPII and Braile, R$2.5 million provided by the S\u00e3o Paulo Development Agency (Desenvolve SP), and R$3 million provided by the Brazilian Development Bank (BNDES).<\/p>\n

Founded by heart surgeon Domingo Marcolino Braile (1938\u20132020) in 1977 (see <\/em>Pesquisa FAPESP issue no. 176<\/em><\/a>), the company\u2014which has also received funding from the Research for Innovation in Small Businesses (RISB, or PIPE in the Portuguese acronym) program to develop a peripheral stent (used to treat narrowing or blockage in blood vessels)\u2014has extensive expertise developing similar equipment. \u201cWe\u2019ve been producing oxygenation membranes for heart surgery since the 1990s. These membranes also function as lungs but for a shorter a period of time, around 6 to 8 hours. The Solis ECMO system uses a similar concept, but is designed to be used for 30 days or more as patients recover cardiorespiratory function in an ICU [Intensive Care Unit],\u201d says Braile, noting that his company\u2019s machine is the first ECMO system developed in the southern hemisphere.<\/p>\n

The technology Braile has developed is state-of-the-art, says Luiz Fernando Can\u00eao, a pediatric heart surgeon at the University of S\u00e3o Paulo School of Medicine\u2019s (FM-USP) Heart Institute (InCor). \u201cTheir machine should be able to compete with counterparts on the global market. All ECMO machines in Brazil are currently imported, so the Solis system provides an added option,\u201d says Can\u00eao, who has formerly chaired the Latin American chapter of the Extracorporeal Life Support Organization (ELSO).<\/p>\n

The ECMO market is currently limited to around a dozen manufacturers, including Getinge in Sweden, Medtronic in Ireland, and LivaNova in the UK. Can\u00eao reckons the Brazilian-made system is on a par with its foreign competitors, at least in theory. \u201cClinical experience will tell how well it operates.\u201d ECMO machines cost between US$35,000 and US$50,000 on the global market\u2014Braile has not disclosed how much its Solis system will cost.<\/p>\n

A single unit has been purchased by a medical equipment distributor in Pernambuco. \u201cWe\u2019ve been approached by potential buyers in several Brazilian states and other countries, and we\u2019re currently in advanced talks with healthcare providers in Germany and Ukraine. Institutions in Colombia and Venezuela have also shown interest,\u201d says Braile.<\/p>\n

ECMO machines consist of essentially two separate parts. The first is the machine proper, which controls blood flow parameters (volume, pressure, and temperature) and pumps blood out from and then back into the patient. The other is an assembly of disposable parts: two cannulas to channel blood to the machine then back into the patient; a set of tubes through which the blood circulates; a centrifugal pump; and the membrane oxygenator, which adds oxygen and removes carbon dioxide like a human lung. The disposable parts are replaced with every new user.<\/p>\n

\u201cOurs is the only ECMO system that is entirely supplied by the manufacturer. Our main competitors outsource some components from other suppliers,\u201d says Braile. ECMO therapy was extensively and successfully used during the H1N1 outbreak in 2009, says the executive, and is similarly being used in Europe and the US to treat COVID-19 patients. \u201cThe mortality curve in these countries has been milder. We hope our system can help to save lives during the novel coronavirus pandemic,\u201d says Braile.<\/p>\n

As a costly and complex procedure that requires highly trained medical staff\u2014\u201cand which is often not covered by health insurance,\u201d notes Can\u00eao\u2014few hospitals in Brazil are equipped to provide ECMO. \u201cOnly 28 healthcare providers are members of and report on their activities to ELSO,\u201d says Can\u00eao, noting that there also several non-members in Brazil using ECMO therapy.<\/p>\n

Can\u00eao hopes a natively developed solution could help to expand availability of ECMO treatment in the country. \u201cAs a standard practice, hospitals here in Brazil often do not purchase and own their medical equipment, but instead use an equipment-as-a-service model and only purchase the disposal parts. In other Latin American countries, hospitals typically buy the complete system,\u201d he explains. \u201cBut without the need for imported spare parts, a locally manufactured machine will be easier to maintain, and this could lead to a change of culture.\u201d<\/p>\n

Project<\/strong>
\nDevelopment and preclinical validation of stent-graft endoprostheisis and catheter for treatment of peripheral vascular diseases (no. 15\/50608-0<\/a>); Grant Mechanism<\/strong> Research for Innovation in Small Businesses program (PIPE\/RISB); FINEP RISB\/PAPPE Grant; Principal Investigator<\/strong> Domingo Marcolino Braile (Braile Biom\u00e9dica); Investment<\/strong> R$744,000.00.<\/p>\n","protected":false},"excerpt":{"rendered":"Brazilian firm develops native out-of-body oxygenation system for patients in critical condition","protected":false},"author":23,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[1560,169],"tags":[243,247],"coauthors":[116],"class_list":["post-393320","post","type-post","status-publish","format-standard","hentry","category-innovative-research-in-small-business-pipe-en","category-technology","tag-innovation","tag-medicine","keywords-coronavirus-en","keywords-covid-19-en","keywords-sars-cov-2-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/393320","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/users\/23"}],"replies":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/comments?post=393320"}],"version-history":[{"count":3,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/393320\/revisions"}],"predecessor-version":[{"id":394083,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/393320\/revisions\/394083"}],"wp:attachment":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/media?parent=393320"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/categories?post=393320"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/tags?post=393320"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/coauthors?post=393320"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}