Main > > >CORONARY. *
Acute Coronary Syndrome (ACS). Non-ST (Stent Thrombosis) Elevation (NSTE-ACS).
Rate of Thrombotic CardioVascular Events (combined endpoint of death, myocardial infarction, or refractory ischemia/re- peat cardiac procedure). Reduction:
Tirofiban.HCl Inj. High-Dose Bolus (HDB)
Brand.
CA Approval Date : 2017. 07.17.
USA Approval Date: 2016. 09.01.
(*) Company : Medicure Inc.
Patent : Expired.
TradeMark: Aggrastat
Web-Site :
www.medicure.com/aggrastat
UpDate: 2019. 02.18.
Acute Coronary Syndrome. Treat.:
Eptifibatide Inj. for IV Use. Brand
USA Approval Date: 1998. 05.18.
(*) Company : Merck & Co. Inc.
Patent : Expired
TradeMark: Integrilin
UpDate: 2019. 02.17.
Cardio.>Arteries. Imaging. (C)
Hybrid System with Simultaneous IntraVascular UltraSound (IVUS) and Optical Coherence Tomography (OCT) Capabilities.
Typically used by Interventional Cardiologists to Image Coronary Anatomy during Angioplasty and Stenting Procedures.
CA Approval Date : 2019. 03.16.
USA FDA 510(k) Clearance: 2018. 05.01.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 03.21.
Cardio.>Artery Disease. DIAG.:Fractio-nal Flow Reserve (FFR)+coronary Compu- ter Tomography Angiography (cCTA)
Imaging.
CA Approval Date : ?
EU Approval Year : 2011.
JP Approval Date : 2016. 11.17.
USA Approval Date: 2014. 12.01.
(*) Company; Patents; Product Name &
Web-Site Available on Request.
UpDate: 2019. 09.23.
Cardio.>Artery Disease. Everolimus Eluting Coronary Stent System
EU Approval Date : 2017. 10.
JP Approval Date : 2018. 04.
USA Approval Date: 2018. 05.23.
(*) Company : Abbott.
TradeMark: XIENCE Sierra
Web-Site : www.xiencestent.com
UpDate: 2018. 05.24.
Cardio.>Artery Disease. Multi Vessel CAD. NonInvasive Evaluation. Fractional Flow Reserve (FFR) Device.
3D Reconstruction of Entire Coronary Tree with FFR values along each Vessel.
Delivers Objective FFR Guidance needed
to optimize PCI therapy decisions.
Derived from Routine X-Rays ACQuired during a diagnostic Angiogram procedure.
Performed Intra-Procedurally during Coronary Angiography.
Use during PCI Intervention.
USA Approval Date: 2018. 12.20.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 07.08.
Cardio.>Artery Disease. Prognostics.
Coronary Calcium Algorithm.
USA FDA 510(k) Clearance: 2018. 07.11.
(*) Company : Zebra Medical Vision Ltd.
Web-Site: www.zebra-med.com
UpDate: 2018. 07.12.
Cardio.>Automated Remote Ischemic Conditioning Device RIC).
Emergency Medicine.
Indications: - Contrast Induced Acute
Kidney Injury
- Elective Percutaneous
Coronary Intervention
(PCI)
- ST-Elevation Myocardial
Infarction
Intended Use: Patients > 18 Years Under
going:
- CardioThoracic Surgery
- Interventional Cardio
Thoracic Procedures
- Evolving MI
Setting: Ambulance; Hospital.
CA Approval Date: ?
EU Approval Date: 2012. 07.18.
(*) Companies; Patents; TradeMark & Web-
Sites Available on Request.
UpDate: 2019. 07.14.
Cardio.>Balloon.
OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.
USA 510(k) Clearance: 2018. 03.01.
(*) Company : Cardiovascular Systems Inc
Web-Site: csi360.com
UpDate: 2018. 03.02.
Cardio.>Guide Extension Catheter.>>
>Creates a Smooth Pathway for balloon
and/or stent delivery by providing
greater flexibility and a smooth
surface. This is important with complex
lesions, calcium, tortuous vessels, and
distal lesions.
>Device Facilitates Delivery of
Interventional Devices in Complex PCI
(percutaneous coronary intervention)
Procedures.
Version 0I EU Launch : 2013. 07.12.
Version 0I USA Launch : 2013. 07.12.
Version II USA Approval: 2017. 03.23.
Version II USA Launch : ?
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 08.22.
Cardio.>Heart Failure (HF). Functional Mitral Regurgitation (FMR). TREAT.: Right Heart Transcatheter Mitral Valve repair (TMVr) Device.
Acute Hemodynamic Efficacy.
FMR results from "Dilation of Left>
>Ventricle" (main pumping chamber of the
heart). As left ventricle increases in
size, the mitral valve also expands.
This "dimensional" increase leads to
MR. which reduces amount of blood flow
out of left ventricle. FMR associated
with "reduced functional capacity"
Implantable Device>Proximal Anchor>
>& Distal Anchor. Utilizing proximity of
coronary sinus to mitral annulus
apparatus, , the device is designed to
reduce mitral annulus dilatation upon
deployment, thereby reducing FMR,
Rapidly delivered via the venous
vasculature, ..
Mitral Regurgitation (MR) grades 2+,3+>
>&4+
Non-Surgical Treatment
Percutaneous Mitral Annuloplasty therapy
Reduce Mitral Annulus Dilatation.
EU Approval Date: 2011. 09.29.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 09.16.
Cardio.>Hystology-Validated Image Analy- sis Software for evaluating "Atheroscle- rotic Plaque" Stability from a single Coronary Computed Tomography Angiogram (CTA) enabled by Machine Intelligence.
EU Approval Date : ?
USA Approval Date: 2018. 12.21.
(*) Company; Patent; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 12.14.
Cardio.>Implantable Cardiac Monitor (ICM) & Patient Alerting System for Acute Coronary Syndromes (ACSs.).
Implantation: Like Pacemaker in less
than 1 hour under local
anesthetic.
Indication : Patients have had prior
ACS events including
Myocardial Infarctions
(Heart Attacks) or
unstable Angina and who
remain at high risk for
recurrent ACS events.
EU Approval Date : 2010. 09.21.
USA Approval Date: 2018. 04.18.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 07.07.
Cardio.>Percutaneous Coronary Intervention (PCI). AntiCoagulant.
Bivalirudin for Injection.
EU Approval Date : 2004. 09.22.
USA Approval Date: 2000. 12.15.
Patents No. 5 & 6 Expiration Date: 2028. 07.27.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2018. 01.23.
Cardio.>Percutaneous Coronary Intervention (PCI). Robotic Assisted.
Vascular Robotics.
JP Approval Date : 2018. 06.09.
USA Approval Date: 2012. 07.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2018. 08.02.
Cardio.>Percutaneous Coronary Intervention (PCI). Steerable MicroCa- theter.
CN Approval Date : 2020. 02.20.
EU Approval Date : ?
USA Approval Dare: ?
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2020. 02.23.
Cardio.>Post CABG (Coronary Artery Bypass Graft). Vein Graft Disease. Prevention: External Co/Cr Stent.
EU Approval Date: 2013. 02.15.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2018. 02.25.
Cardio.>Ridaforolimus-Eluting Coronary Stent System.
About Percutaneous Coronary Intervention (PCI).
PCI is a NonSurgical Procedure that often uses a Catheter to place a Stent to Open Blocked Coronary Arteries caused by "Coronary Artery Disease. (CAD)."
EU Approval Date : 2017. 10.26.
USA Approval Date: 2017. 11.30.
(*) Company; Patents; TradeMarks & Web-
Sites Available on Request.
UpDate: 2017. 12.01.
Guide Extension Catheter. to Support Complex Coronary Cases.
FDA Cleared and CE Marked.
Global Launch Date: 1019. 05.16.
(*) Company : Medtronic.
TradeMark: Telescope
UpDate: 2019. 08.20.
Percutaneous Coronary Intervention (PCI). Anticoagulant. Bivalirudin.
USA Approval Date: 2018. 01.22.
(*) Company: Baxter.
UpDate: 2019. 03.25.
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