MIAMI, Dec. 11, 2024 (GLOBE NEWSWIRE) -- RapidPulse, Inc., a Delaware corporation headquartered in Miami, Florida focused on improving the treatment success rate for acute ischemic stroke (AIS) announced that the United States Food and Drug Administration (FDA) agreed that RapidPulse can begin enrollment in an Investigational Device Exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow U.S. and European patient enrollment in 2025 to commence in a study designed to demonstrate the RapidPulse patented method of precisely pulsed aspiration is safe and effective in the treatment of AIS. RapidPulse's technology is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits.

The RapidPulse® system which will be used in the IDE study was recently trialed in nineteen LVO patients enrolled at Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asuncion in Paraguay and Istanbul Aydin Universitesi in Turkey. "Using the new RapidPulse® system, we achieved a 68% first pass effect of TICI 2c or better. This means almost 7 out of 10 AIS patients had near perfect or perfect reperfusion after one attempt. We were just as impressed that the RapidPulse catheter is as navigable as the benchmark catheters on the market and that 100% of patients achieved TICI 2b or higher within three passes," stated Serdar Geyik, M.D. the lead investigator in Istanbul.

kAm%96 #2A:5!F=D6 !:G@E2= $EF5J :D E2C86E65 E@ 6?C@== 2AAC@I:>2E6=J 'f_ A2E:6?ED H:E9 C646?E @?D6E @7 DJ>AE@>D :?5:42E:G6 @7 =2C86 G6DD6= @44=FD:@? W{'~X :? px$] x? E96 &]$] 2=@?6[ 6249 J62C 2? 6DE:>2E65 f__[___ DEC@<6D @44FC H96? 2 4=@E 3=@4<D 3=@@5 7=@H E@ E96 3C2:?]' !C:@C DEF5:6D 92G6 D9@H? A2E:6?ED 92G6 =@H6C C2E6D @C >@CE2=:EJ 2?5 >@C3:5:EJ H96? 4=:?:4:2?D 42? 7F==J C6DE@C6 3=@@5 7=@H @? E96 7:CDE 2EE6>AE 2E 4=@E C6>@G2=]a q6EE6C 4=@E C6>@G2= C2E6D 2=D@ C65F46 E96 9@DA:E2= =6?8E9 @7 DE2J 2?5 @G6C2== 962=E942C6 DJDE6> 4@DED]bk^Am kAm!C6G:@FD=J usp\4=62C65 56G:46D 7@C E96 EC62E>6?E @7 DEC@<6 FD6 6:E96C DE2E:4 2DA:C2E:@?[ 2 DE6?E C6EC:6G6C[ @C 2 4@>3:?2E:@? @7 E96 EH@] w@H6G6C[ >@DE AF3=:D965 DEF5:6D 92G6 D9@H? E96D6 4FCC6?E=J 2G2:=23=6 E649?@=@8:6D @?=J 249:6G6 4@>A=6E6 @C ?62C 4@>A=6E6 C6A6C7FD:@? @? E96 7:CDE 2EE6>AE :? 2AAC@I:>2E6=J c @FE @7 '_ A2E:6?ED] #2A:5!F=D6 :D E96 7:CDE 4@>A2?J E@ A2E6?E 2 DJDE6> E92E C2A:5=J 4J4=6D 2DA:C2E:@? 2?5 :D 56D:8?65 E@ :>AC@G6 E96 C2E6 @7 7F== 4=@E :?86DE:@? H:E9 9:896C C6A6C7FD:@? C2E6D @? E96 7:CDE A2DD 2?5 56>@?DEC2E6 :>AC6DD:G6 C6DF=ED H96? FA E@ E9C66 A2DD6D 2C6 >256]k^AmkAm#2A:5!F=D6 92D 56G6=@A65 2 4@>A=6E6 DJDE6> :?4=F5:?8 2 AC@AC:6E2CJ 4@?D@=6 E@ 56=:G6C AC64:D6[ AF=D65 2DA:C2E:@?[ 9:89=J EC24<23=6 42E96E6CD[ 2?5 2 D>2CE EF3:?8 D6E H9:49 6?DFC6D #2A:5!F=D6'D AC@AC:6E2CJ 4J4=:4 2=8@C:E9> :D EF?65 E@ 6249 42E96E6C D:K6] "%9C@F89 @FC 6IE6?D:G6 56G6=@A>6?E H@C<[ H6 <?@H E96 2=8@C:E9>'D AC64:D:@? 2?5 9@H :E :D EC2?D=2E65 E9C@F89 E96 42E96E6C E@ E96 4=@E 7246 :D 4C:E:42= E@ 9:89 DF446DD C2E6D[" D2:5 $62? |4qC2J6C[ rt~ @7 #2A:5!F=D6] "~FC DJDE6> :D >256 E@ 2==@H DEC@<6 E62>D E@ BF:4<=J 2?5 62D:=J 86E 2 C62==J A@H6C7F= E@@= 7@C 4=@E C6>@G2= E@ E96 C:89E =@42E:@? D@ E96J 92G6 E96 36DE 492?46 @7 C6DE@C:?8 7F== C6A6C7FD:@? @? E96 7:CDE A2DD]"k^AmkAmp AC:@C DEF5J H:E9 E96 #2A:5!F=D6® DJDE6> 56>@?DEC2E65 A9JD:4:2?D H6C6 23=6 E@ 249:6G6 2 a'\A@:?E :>AC@G6>6?E :? E96:C 7:CDE A2DD 4=@E C6>@G2= C2E6 H96? 4@>A2C65 E@ 4@?E6>A@C2CJ A2E:6?ED H9@ H6C6 EC62E65 H:E9 ;FDE DE2E:4 2DA:C2E:@?]ck^AmkAmx?DE:EFE:@?2= #6G:6H q@2C5 2AAC@G2=D >FDE 36 @3E2:?65 AC:@C E@ :?:E:2E:?8 6?C@==>6?E 2E E96 :?G6DE:82E:@?2= D:E6D] &A@? 4@>A=6E:@? @7 E96 #2A:5!F=D6 !:G@E2= $EF5J[ E96 52E2 H:== 36 DF3>:EE65 E@ E96 usp :? 4@?D:56C2E:@? 7@C C646:G:?8 d'_W<X 4=62C2?46 E@ >2C<6E E96 56G:46] |@C6 :?7@C>2E:@? @? E96 #2A:5!F=D6 !:G@E2= $EF5J 6?5A@:?ED 2?5 A2CE:4:A2E:?8 9@DA:E2= DJDE6>D 42? 36 7@F?5 2E k2 9C67lQ9EEADi^^HHH]8=@36?6HDH:C6]4@>^%C24<6Cn52E2l~Ia+D_~?}p%65?'ytABHh|B!afAv_tp$hhH~;hDy(3*b7K!8*A$rDaI+3{5\e\3(p)Gu&Gc=h4r)@)8c'u*&\*)>0@H_"'g?:@z}sd$>6+@lQ C6=lQ?@7@==@HQmHHH]4=:?:42=EC:2=D]8@Gk^2m]k^Am kAm{62C? >@C6 23@FE #2A:5!F=D6 2E k2 9C67lQ9EEADi^^HHH]8=@36?6HDH:C6]4@>^%C24<6Cn52E2la+'J+>@&t*p*cg{~7=DCeD*(y&HgKrAG7J&"(p0h}72fz7h:'v>@@'hrgD7?<45_p$~H{q9y#stafg@~{;x9)8x5~xs<hD2*$\A4(!bAHEplQ C6=lQ?@7@==@HQm9EEADi^^C2A:5AF=D6>65]4@>^k^2mk^AmkAm|tsxp r~}%pr%ik^AmkAms@F8 {255[ k2 9C67lQ9EEADi^^HHH]8=@36?6HDH:C6]4@>^%C24<6Cn52E2lh*})wd+|<a!s2#F0vw!+h>**@z:?bIH_b&|43'"e;AcD{+4A!hG\2~Gdb_h@5gvI=_3>KJfr_(|7Fs#5tc=+:78I*b758}K0f6F9y6)x?'8lQ C6=lQ?@7@==@HQm:?7@oC2A:5AF=D6>65]4@>k^2m[ b_d\aee\bbggk^AmkAmk^Amk@=mk=:mk2 9C67lQ9EEADi^^HHH]454]8@G^DEC@<6^52E2\C6D62C49^724ED\DE2ED^nrsr0ppC670'2=l9EEADi^^HHH]454]8@G^DEC@<6^724ED]9E>Q C6=lQ?@7@==@HQm9EEADi^^HHH]454]8@G^DEC@<6^724ED]9E>k^2mk^=:mk=:m+2:52E[ ~D2>2 ~][ 6E 2=] Qu:CDE A2DD 67764Ei 2 ?6H >62DFC6 7@C DEC@<6 E9C@>364E@>J 56G:46D]Q k6>m$EC@<6k^6>m ch[b Wa_'gXi ee_\eee]k^=:mk=:ms2HD@?[ y6DD6 6E 2=] "pDD@4:2E:@? 36EH66? 5:D23:=:EJ >62DFC6D 2?5 962=E942C6 4@DED 27E6C :?:E:2= EC62E>6?E 7@C 24FE6 DEC@<6]" k6>m$EC@<6k^6>m bg[e Wa__fXi 'ghb\g] 5@:i'_]''e'^$%#~ztpwp]'_e]cfabg'k^=:mk=:mq2;C2>:[ p][ 6E 2=] "#2A:5!F=D6%| 4J4=:4 2DA:C2E:@? DJDE6> 7@C 24FE6 :D496>:4 DEC@<6 5F6 E@ =2C86 G6DD6= @44=FD:@?D]" x?E6CG6?E:@?2= }6FC@C25:@=@8J] |2C49 a_ac] 5@:i'_]''ff^'dh'_'hhac'abh_hck^=:mk^@=mkAmk^AmkAmk^Am