{"id":47302,"date":"2026-04-09T00:04:30","date_gmt":"2026-04-08T17:04:30","guid":{"rendered":"https:\/\/saigonbiz.com\/vn\/cong-ty-supira-medical-thong-bao-viec-fda-da-phe-duyet-thu-nghiem-lam-sang-then-chot-support-ii-nhung-tien-bo-trong-dieu-tri-soc-tim-va-viec-bo-nhiem-ong-d-keith-grossman-vao-hoi-dong-quan-tri\/"},"modified":"2026-04-09T00:04:30","modified_gmt":"2026-04-08T17:04:30","slug":"cong-ty-supira-medical-thong-bao-viec-fda-da-phe-duyet-thu-nghiem-lam-sang-then-chot-support-ii-nhung-tien-bo-trong-dieu-tri-soc-tim-va-viec-bo-nhiem-ong-d-keith-grossman-vao-hoi-dong-quan-tri","status":"publish","type":"post","link":"https:\/\/saigonbiz.com\/vn\/cong-ty-supira-medical-thong-bao-viec-fda-da-phe-duyet-thu-nghiem-lam-sang-then-chot-support-ii-nhung-tien-bo-trong-dieu-tri-soc-tim-va-viec-bo-nhiem-ong-d-keith-grossman-vao-hoi-dong-quan-tri\/","title":{"rendered":"C\u00f4ng ty Supira Medical Th\u00f4ng B\u00e1o vi\u1ec7c FDA \u0111\u00e3 Ph\u00ea Duy\u1ec7t Th\u1eed Nghi\u1ec7m L\u00e2m S\u00e0ng Then Ch\u1ed1t SUPPORT II, Nh\u1eefng Ti\u1ebfn B\u1ed9 trong \u0110i\u1ec1u Tr\u1ecb S\u1ed1c Tim v\u00e0 vi\u1ec7c B\u1ed5 Nhi\u1ec7m \u00d4ng D. Keith Grossman v\u00e0o H\u1ed9i \u0110\u1ed3ng Qu\u1ea3n Tr\u1ecb"},"content":{"rendered":"
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C\u00e1c c\u1ed9t m\u1ed1c quan tr\u1ecdng kh\u1eb3ng \u0111\u1ecbnh ti\u1ebfn b\u1ed9 l\u00e2m s\u00e0ng v\u00e0 c\u1ee7ng c\u1ed1 n\u1ec1n t\u1ea3ng th\u01b0\u01a1ng m\u1ea1i<\/i><\/p>\n

LOS GATOS, California<\/span>, ng\u00e0y 8 th\u00e1ng 4 n\u0103m 2026<\/span> \/PRNewswire\/ —\u00a0Supira Medical, Inc.<\/b><\/a>\u00a0(Supira), m\u1ed9t c\u00f4ng ty giai \u0111o\u1ea1n l\u00e2m s\u00e0ng\u00a0 t\u1eadp trung v\u00e0o vi\u1ec7c chuy\u1ec3n \u0111\u1ed5i th\u1ecb tr\u01b0\u1eddng thi\u1ebft b\u1ecb h\u1ed7 tr\u1ee3 t\u00e2m th\u1ea5t qua da (pVAD), h\u00f4m nay th\u00f4ng b\u00e1o \u0111\u00e3 \u0111\u01b0\u1ee3c FDA cho ph\u00e9p tri\u1ec3n khai Th\u1eed Nghi\u1ec7m Then Ch\u1ed1t SUPPORT II. Th\u1eed nghi\u1ec7m n\u00e0y \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 cung c\u1ea5p d\u1eef li\u1ec7u cho h\u1ed3 s\u01a1 xin c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m (PMA) v\u00e0 l\u00e0 m\u1ed9t b\u01b0\u1edbc ti\u1ebfn quan tr\u1ecdng trong l\u1ed9 tr\u00ecnh th\u00e2m nh\u1eadp th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3.<\/p>\n

SUPPORT II (SU<\/u>pira System in P<\/u>atients Undergoing High-Risk P<\/u>ercutaneous CO<\/u>ronaR<\/u>y InT<\/u>ervention (H\u1ec7 Th\u1ed1ng Supira d\u00f9ng cho B\u1ec7nh Nh\u00e2n Tr\u1ea3i Qua Can Thi\u1ec7p M\u1ea1ch V\u00e0nh Qua Da Nguy C\u01a1 Cao – HRPCI)) l\u00e0 m\u1ed9t nghi\u00ean c\u1ee9u c\u00f3 \u0111\u1ed1i ch\u1ee9ng ng\u1eabu nhi\u00ean, ti\u1ebfn c\u1ee9u nh\u1eb1m \u0111\u00e1nh gi\u00e1 t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a pVAD th\u1ebf h\u1ec7 m\u1edbi tr\u00ean nh\u1eefng b\u1ec7nh nh\u00e2n tr\u1ea3i qua HRPCI. Nghi\u00ean c\u1ee9u s\u1ebd tuy\u1ec3n ch\u1ecdn t\u1ed1i \u0111a 385 b\u1ec7nh nh\u00e2n t\u1ea1i t\u1ed1i \u0111a 40 \u0111\u1ecba \u0111i\u1ec3m tr\u00ean kh\u1eafp Hoa K\u1ef3. C\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u ch\u00ednh c\u1ea5p qu\u1ed1c gia d\u1eabn d\u1eaft nghi\u00ean c\u1ee9u g\u1ed3m Ti\u1ebfn s\u0129 Ajay Kirtane (Gi\u00e1o S\u01b0 Y Khoa t\u1ea1i \u0110\u1ea1i h\u1ecdc Columbia, Tr\u01b0\u1eddng Cao \u0110\u1eb3ng Y Khoa Vagelos\/B\u1ec7nh Vi\u1ec7n New York-Presbyterian) v\u00e0 Ti\u1ebfn S\u0129 David Kandzari (Gi\u00e1m \u0110\u1ed1c Vi\u1ec7n Tim M\u1ea1ch Piedmont ki\u00eam Gi\u00e1m \u0110\u1ed1c Khoa H\u1ecdc c\u1ee7a Piedmont Healthcare, Atlanta, GA).<\/p>\n

Ti\u1ebfn s\u0129 Kandzari chia s\u1ebb: “Trong HRPCI, quy\u1ebft \u0111\u1ecbnh s\u1eed d\u1ee5ng h\u1ed7 tr\u1ee3 huy\u1ebft \u0111\u1ed9ng th\u01b0\u1eddng b\u1ecb \u1ea3nh h\u01b0\u1edfng b\u1edfi kh\u1ea3 n\u0103ng ti\u1ebfp c\u1eadn, t\u00ednh kh\u1ea3 thi v\u00e0 s\u1ef1 c\u00e2n b\u1eb1ng gi\u1eefa h\u1ed7 tr\u1ee3 v\u1edbi hi\u1ec7u qu\u1ea3 th\u1ee7 thu\u1eadt. M\u1ed9t h\u1ec7 th\u1ed1ng c\u00f3 th\u1ec3 cung c\u1ea5p h\u1ed7 tr\u1ee3 tu\u1ea7n ho\u00e0n hi\u1ec7u qu\u1ea3 v\u1edbi k\u00edch th\u01b0\u1edbc nh\u1ecf g\u1ecdn h\u01a1n c\u00f3 ti\u1ec1m n\u0103ng m\u1edf r\u1ed9ng \u0111\u1ed1i t\u01b0\u1ee3ng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u00e0 n\u00e2ng cao hi\u1ec7u qu\u1ea3 \u0111i\u1ec1u tr\u1ecb.”<\/p>\n

Theo Ti\u1ebfn s\u0129 Kirtane: “Vi\u1ec7c s\u1eed d\u1ee5ng pVAD \u0111\u00fang c\u00e1ch cho ph\u00e9p c\u00e1c b\u00e1c s\u0129 th\u1ef1c hi\u1ec7n c\u00e1c th\u1ee7 thu\u1eadt ph\u1ee9c t\u1ea1p nh\u1ea5t m\u1ed9t c\u00e1ch an to\u00e0n, mang \u0111\u1ebfn c\u01a1 h\u1ed9i HRPCI cho nh\u1eefng b\u1ec7nh nh\u00e2n v\u1ed1n c\u00f3 r\u1ea5t \u00edt l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00e2y. Vi\u1ec7c kh\u1edfi \u0111\u1ed9ng th\u1eed nghi\u1ec7m ng\u1eabu nhi\u00ean then ch\u1ed1t cho thi\u1ebft b\u1ecb h\u1ed7 tr\u1ee3 huy\u1ebft \u0111\u1ed9ng m\u1edbi, k\u00edch th\u01b0\u1edbc nh\u1ecf g\u1ecdn h\u01a1n n\u00e0y l\u00e0 m\u1ed9t b\u01b0\u1edbc ti\u1ebfn quan tr\u1ecdng trong vi\u1ec7c n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng ch\u0103m s\u00f3c cho nh\u00f3m b\u1ec7nh nh\u00e2n c\u00f3 nguy c\u01a1 cao nh\u1ea5t.”<\/p>\n

Ti\u1ebfn b\u1ed9 trong \u0111i\u1ec1u tr\u1ecb S\u1ed1c Tim<\/b><\/p>\n

Ngo\u00e0i th\u1eed nghi\u1ec7m SUPPORT II, c\u00f4ng ty c\u0169ng \u0111ang n\u1ed7 l\u1ef1c c\u1ea3i thi\u1ec7n c\u00e1c l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n b\u1ecb s\u1ed1c tim. Kinh nghi\u1ec7m \u0111i\u1ec1u tr\u1ecb g\u1ea7n \u0111\u00e2y b\u00ean ngo\u00e0i Hoa K\u1ef3 \u0111\u00e3 ghi nh\u1eadn nh\u00f3m b\u1ec7nh nh\u00e2n s\u1ed1c tim \u0111\u1ea7u ti\u00ean s\u1eed d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p ti\u1ebfp c\u1eadn \u0111\u1ed9ng m\u1ea1ch n\u00e1ch qua da \u0111\u1ec3 cho ph\u00e9p b\u1ec7nh nh\u00e2n v\u1eadn \u0111\u1ed9ng trong khi 10Fr pVAD \u0111ang ho\u1ea1t \u0111\u1ed9ng.<\/p>\n

Nh\u00ecn chung, nh\u1eefng c\u1ed9t m\u1ed1c n\u00e0y l\u00e0m n\u1ed5i b\u1eadt ti\u1ec1m n\u0103ng c\u1ee7a thi\u1ebft b\u1ecb h\u1ed7 tr\u1ee3 tu\u1ea7n ho\u00e0n c\u01a1 h\u1ecdc t\u1ea1m th\u1eddi th\u1ebf h\u1ec7 m\u1edbi; m\u1edf r\u1ed9ng c\u00e1c l\u1ef1a ch\u1ecdn ti\u1ebfp c\u1eadn, h\u1ed7 tr\u1ee3 kh\u1ea3 n\u0103ng v\u1eadn \u0111\u1ed9ng v\u00e0 n\u00e2ng cao ph\u01b0\u01a1ng th\u1ee9c qu\u1ea3n l\u00fd b\u1ec7nh nh\u00e2n nguy k\u1ecbch.<\/p>\n

\u0110\u1ed1i v\u1edbi c\u00e1c b\u00e1c s\u0129 tim m\u1ea1ch can thi\u1ec7p v\u00e0 chuy\u00ean gia v\u1ec1 suy tim, thi\u1ebft b\u1ecb h\u1ed7 tr\u1ee3 huy\u1ebft \u0111\u1ed9ng to\u00e0n di\u1ec7n v\u1edbi s\u1ef1 linh ho\u1ea1t trong v\u1ecb tr\u00ed ti\u1ebfp c\u1eadn qua da v\u00e0 kh\u1ea3 n\u0103ng v\u1eadn \u0111\u1ed9ng c\u1ee7a b\u1ec7nh nh\u00e2n trong qu\u00e1 tr\u00ecnh h\u1ed7 tr\u1ee3 l\u00e0 nh\u1eefng b\u01b0\u1edbc \u0111i quan tr\u1ecdng h\u01b0\u1edbng t\u1edbi vi\u1ec7c c\u1ea3i thi\u1ec7n to\u00e0n b\u1ed9 quy tr\u00ecnh ch\u0103m s\u00f3c cho b\u1ec7nh nh\u00e2n s\u1ed1c tim.<\/p>\n

B\u1ed5 nhi\u1ec7m \u00f4ng D. Keith Grossman, m\u1ed9t chuy\u00ean gia k\u1ef3 c\u1ef1u trong ng\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf, l\u00e0m Th\u00e0nh Vi\u00ean \u0110\u1ed9c L\u1eadp c\u1ee7a H\u1ed9i \u0110\u1ed3ng Qu\u1ea3n Tr\u1ecb<\/b><\/p>\n

Song song v\u1edbi nh\u1eefng c\u1ed9t m\u1ed1c l\u00e2m s\u00e0ng n\u00e0y, Supira c\u0169ng th\u00f4ng b\u00e1o b\u1ed5 nhi\u1ec7m \u00f4ng D. Keith Grossman v\u00e0o H\u1ed9i \u0110\u1ed3ng Qu\u1ea3n Tr\u1ecb c\u1ee7a c\u00f4ng ty. V\u1edbi h\u01a1n 40 n\u0103m kinh nghi\u1ec7m l\u00e3nh \u0111\u1ea1o trong ng\u00e0nh c\u00f4ng ngh\u1ec7 y t\u1ebf v\u00e0 t\u1eebng \u0111\u00f3ng vai tr\u00f2 n\u1ec1n t\u1ea3ng trong l\u0129nh v\u1ef1c h\u1ed7 tr\u1ee3 tu\u1ea7n ho\u00e0n c\u01a1 h\u1ecdc, \u00f4ng\u00a0Grossman s\u1ebd gi\u00fap c\u1ee7ng c\u1ed1 tr\u1ecdng t\u00e2m c\u1ee7a c\u00f4ng ty trong vi\u1ec7c m\u1edf r\u1ed9ng quy m\u00f4 \u0111\u1ec3 s\u1eb5n s\u00e0ng th\u01b0\u01a1ng m\u1ea1i h\u00f3a s\u1ea3n ph\u1ea9m v\u00e0 t\u0103ng tr\u01b0\u1edfng.<\/p>\n

Ti\u1ebfn S\u0129 Nitin Salunke, Ch\u1ee7 T\u1ecbch ki\u00eam Gi\u00e1m \u0110\u1ed1c \u0110i\u1ec1u H\u00e0nh c\u1ee7a Supira Medical, cho bi\u1ebft: “\u00d4ng Keith mang \u0111\u1ebfn s\u1ef1 k\u1ebft h\u1ee3p qu\u00fd gi\u00e1 gi\u1eefa k\u1ef7 lu\u1eadt v\u1eadn h\u00e0nh, s\u1ef1 am hi\u1ec3u th\u1ecb tr\u01b0\u1eddng v\u00e0 t\u1ea7m nh\u00ecn chi\u1ebfn l\u01b0\u1ee3c. Vi\u1ec7c \u00f4ng \u1ea5y gia nh\u1eadp H\u1ed9i \u0110\u1ed3ng Qu\u1ea3n Tr\u1ecb v\u1edbi t\u01b0 c\u00e1ch l\u00e0 th\u00e0nh vi\u00ean \u0111\u1ed9c l\u1eadp ph\u1ea3n \u00e1nh cam k\u1ebft c\u1ee7a ch\u00fang t\u00f4i trong vi\u1ec7c x\u00e2y d\u1ef1ng m\u1ed9t t\u1ed5 ch\u1ee9c kh\u00f4ng ch\u1ec9 kh\u00e1c bi\u1ec7t v\u1ec1 n\u0103ng l\u1ef1c l\u00e2m s\u00e0ng m\u00e0 c\u00f2n c\u00f3 kh\u1ea3 n\u0103ng ho\u1ea1t \u0111\u1ed9ng tr\u00ean quy m\u00f4 l\u1edbn.”<\/p>\n

\u00d4ng Grossman nh\u1eadn \u0111\u1ecbnh: “Supira \u0111\u00e3 thi\u1ebft l\u1eadp m\u1ed9t n\u1ec1n t\u1ea3ng l\u00e2m s\u00e0ng v\u00e0 c\u00f4ng ngh\u1ec7 v\u1eefng ch\u1eafc, t\u1ea1o n\u00ean v\u1ecb th\u1ebf \u0111\u1ed9c \u0111\u00e1o \u0111\u1ec3 thay \u0111\u1ed5i th\u1ecb tr\u01b0\u1eddng pVAD \u0111ang ph\u00e1t tri\u1ec3n v\u00e0 v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c khai th\u00e1c tri\u1ec7t \u0111\u1ec3. T\u00f4i r\u1ea5t mong \u0111\u01b0\u1ee3c \u0111\u1ed3ng h\u00e0nh c\u00f9ng c\u00f4ng ty trong qu\u00e1 tr\u00ecnh ti\u1ebfn h\u00e0nh th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng then ch\u1ed1t v\u00e0 chu\u1ea9n b\u1ecb tr\u1edf th\u00e0nh m\u1ed9t trong nh\u1eefng \u0111\u01a1n v\u1ecb h\u00e0ng \u0111\u1ea7u trong vi\u1ec7c cung c\u1ea5p c\u00e1c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n b\u1ecb s\u1ed1c tim v\u00e0 can thi\u1ec7p m\u1ea1ch v\u00e0nh qua da nguy c\u01a1 cao (PCI).”<\/p>\n

Gi\u1edbi thi\u1ec7u v\u1ec1 Supira Medical, Inc. <\/b><\/p>\n

Supira Medical t\u1eadp trung v\u00e0o vi\u1ec7c ph\u00e1t tri\u1ec3n thi\u1ebft b\u1ecb h\u1ed7 tr\u1ee3 t\u00e2m th\u1ea5t qua da pVAD th\u1ebf h\u1ec7 m\u1edbi, ph\u1ee5c v\u1ee5 c\u00e1c b\u1ec7nh nh\u00e2n c\u00f3 nguy c\u01a1 cao tr\u1ea3i qua c\u00e1c th\u1ee7 thu\u1eadt can thi\u1ec7p v\u00e0 b\u1ec7nh nh\u00e2n s\u1ed1c tim. \u0110\u1ebfn nay, H\u1ec7 Th\u1ed1ng Supira \u0111\u00e3 \u0111\u01b0\u1ee3c \u1ee9ng d\u1ee5ng \u0111i\u1ec1u tr\u1ecb tr\u00ean 99 b\u1ec7nh nh\u00e2n. \u0110\u1ec3 t\u00ecm hi\u1ec3u th\u00eam v\u1ec1 Supira Medical, vui l\u00f2ng truy c\u1eadp www.supiramedical.com<\/a>.<\/p>\n

Thi\u1ebft b\u1ecb h\u1ed7 tr\u1ee3 t\u00e2m th\u1ea5t qua da pVAD r\u1ea5t quan tr\u1ecdng trong vi\u1ec7c h\u1ed7 tr\u1ee3 ch\u1ee9c n\u0103ng tim m\u1ea1ch trong qu\u00e1 tr\u00ecnh can thi\u1ec7p m\u1ea1ch v\u00e0nh qua da (HRPCI) v\u00e0 \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb s\u1ed1c tim. B\u1ec7nh nh\u00e2n HRPCI th\u01b0\u1eddng c\u00f3 c\u1ea5u tr\u00fac m\u1ea1ch v\u00e0nh ph\u1ee9c t\u1ea1p, huy\u1ebft \u0111\u1ed9ng h\u1ecdc suy gi\u1ea3m v\u00e0 nhi\u1ec1u b\u1ec7nh l\u00fd n\u1ec1n. Trong khi \u0111\u00f3, s\u1ed1c tim l\u00e0 m\u1ed9t t\u00ecnh tr\u1ea1ng c\u00f3 t\u1ef7 l\u1ec7 t\u1eed vong cao do tim qu\u00e1 y\u1ebfu kh\u00f4ng th\u1ec3 b\u01a1m \u0111\u1ee7 m\u00e1u \u0111\u1ebfn c\u00e1c c\u01a1 quan tr\u1ecdng y\u1ebfu, th\u01b0\u1eddng l\u00e0 h\u1eadu qu\u1ea3 c\u1ee7a nh\u1ed3i m\u00e1u c\u01a1 tim ho\u1eb7c suy tim.<\/p>\n

H\u1ec7 Th\u1ed1ng Supira hi\u1ec7n v\u1eabn \u0111ang trong qu\u00e1 tr\u00ecnh nghi\u00ean c\u1ee9u v\u00e0 ch\u01b0a \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p kinh doanh t\u1ea1i Hoa K\u1ef3 hay b\u1ea5t k\u1ef3 n\u01a1i n\u00e0o kh\u00e1c tr\u00ean th\u1ebf gi\u1edbi. Theo lu\u1eadt li\u00ean bang, thi\u1ebft b\u1ecb n\u00e0y ch\u1ec9 \u0111\u01b0\u1ee3c ph\u00e9p s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch nghi\u00ean c\u1ee9u.<\/p>\n

Li\u00ean H\u1ec7 Truy\u1ec1n Th\u00f4ng:<\/b>
Craig Brandli
Ph\u00f3 Ch\u1ee7 T\u1ecbch Marketing
craig@supiramedical.com<\/a><\/p>\n

Logo –\u00a0https:\/\/mma.prnasia.com\/media2\/2950608\/SupiraMedical_Logo_Logo_Logo.jpg?p=medium600<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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