Download - FDA Clears New Mechanical Thrombectomy Platformaspirationmedical.com/press/05-06-2020-aspire-max.pdf · Mechanical Thrombectomy System includes (20) new large-lumen, flexible, and

FDAClearsNewMechanicalThrombectomyPlatformNewlargecatheterplatformFDAclearedtoremovebloodclotsfromperipheralvessels

PARKCITY,UT,May6,2020/24-7PressRelease.ControlMedicalTechnologyannouncedtheFDAclearedtheControl7–11FMechanicalThrombectomyplatformtoremovebloodclotsfromperipheralvessels.Bloodclotremoval(thrombectomy)isacommonprocedure.Coronarythrombectomyisassociatedwithacutemyocardialinfarction(AMI),neurovascularthrombectomyisassociatedwithacuteischemicstroke,andperipheralthrombectomyisassociatedwithperipheralarterialdisease(PAD),acutelimbischemia(ALI),criticallimbischemia(CLI),chronictotalocclusion(CTO),deepveinthrombosis(DVT),pulmonaryembolism(PE),andotherperipheralvasculardisease(PVD).“ThisFDAclearancequadruplesourproductofferingandimprovesourabilitytohelppatients,”saidShawnFojtik,PresidentofControlMedicalTechnologyinParkCity,Utah.“TheControl7–11FMechanicalThrombectomySystemincludes(20)newlarge-lumen,flexible,andkink-resistantcathetersw/dilatorspoweredbytheControlMechanicalAspiratorand/oranelectromechanicalpump.”Duringaprocedure,clinicianstypicallyaccessthefemoralarteryorvein,trackacatheteroveraguidewiretothethrombus,andthenapplylow-performancesuctionwithabasicsyringeorpulsedcontinualhigh-performancevacuumwithaControlMechanicalAspiratororanelectromechanicalpump.“Bloodclotsrangefromsoft-freshclotstohard-agedthrombus,”continuedMr.Fojtik.“Cliniciansneedmorecost-effectivetoolstoremovebloodclots.Weplantointroducemorecatheterandelectromechanicalpumpinnovationsforuseinperipheral,coronary,andneurovascularprocedures.”ThenewControl7–11FMechanicalThrombectomySystemincludes7F(0.090”)outerdiameter(OD)to11F(0.140”)ODcatheterswithflexibledilatorsforimprovedtracking.CathetersmaybeconnectedtotheControlAspiratorand/oranelectromechanicalpumpforincreasedspeed,force,volume,andcontrol.ControlMedical’splatformalsoincludestheControl5-6FMechanicalThrombectomySystemwithover-the-wirecathetersforperipheralvasculatureandtheControlRX-LPMechanicalThrombectomySystemwithrapidexchangecathetersforperipheralandcoronaryvasculature.DatawasrecentlypublishedusingtheControlRX-LPMechanicalThrombectomySystem’storemovebloodclotsfromtotalocclusionsduringheartattack[AdamsG,CavrosN,TaiZ,“Novel

MechanicalThrombectomyDeviceforTreatmentofAcuteMyocardialInfarction:ARetrospectiveReport,”JournalofInvasiveCardiology,2020;32(4):142-146].ControlMedicalTechnologyisaprivatecompanythatdesigns,develops,andcommercializesmedicaldeviceswww.AspirationMedical.com.ControlMedicalTechnologyMediacontact:CarmenAguilara(954)[email protected].