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Cardio.>Arrhytmia. 3D NonInvasive Loca-lization System.
Intended>ACQuisition, Analysis, Display
& storage of cardiac electro-
physiology data and maps for
analysis by a physician.
Intended>Used as Pre-Procedure>Planning
tool for patients with structu-
rally normal hearts undergoing
ablation treatment for idiopa-
thic ventricular arrhythmias.
System Consists of a hand-held 3D came-
ra, & an off-the-shelf laptop
computer with proprietary soft-
ware.
System Uses MRI or CT Scan along with a
standard 12-lead ΕCG to computer-
generate color-coded 3D mapping
images of the heart to indicate
the area of earliest activation.
Using a 3D photograph of the pa-
tient s chest, an MRI or CT
(DICOM image), and a standard 12-
lead ECG, the system generates a
3D rendering of the patient s
heart with superimposed color
coding to indicate the area of
earliest activation.
EU Approval Year : 2017.
USA Approval Date: 2019. 06.26.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 07.07.




Cardio.>Arrhytmia. Atrial Fibrillation (AFi). Diag.: High Resolution (HR) Imaging & Non-Contact Mapping System.
Detects & Displays both Standard Volta-
ge-based & HR "Dipole Density (Charge-
Source) Maps". The System uniquely com-
bines "UltraSound (US) Anatomy Construc-
tion" with ability to map the "Electri-
cal-Conduction" of each "HeartBeat" to
Identify Complex Arrhytmias across the
entire "Atrial Chamber". Following each Ablation Treat. the Heart can be "Re-
Mapped" in seconds to continually Visua-
lize any changes from the prior Mapping.
Individualized & Personalized Catheter
Ablation.
IntraCardiac Echocardiography (ICE) &
ElectroAnatomic Mapping Systems.
System ACQuires up to 115,000 Ultra-
Sound (US) Data Points/Minute to rapidly
create an Anatomic Reconstruction of a
chamber of heart & up to 150,000 Biopo-
tential samples/Second to create a 3D
map of cardiac electrical activity of whole chamber in real-time.
System allows ElectroPhysiologists to
tailor TREATs. for each individual pa-
tient & then adapt that TREAT. Iterati-
vely-on the fly-while the patient is
still in ElectroPhysiology (EP) lab.
With System, Physicians can create a
full-chamber, 360-Degree Look at the
Atrium in Real-Time for each individual
patient enabling truly customized TREAT.
for every case using an iterative map,
ablate, re-map, ablate strategy.
EU Approval Date : 2016. 05.04.
USA Approval Date: 2017. 10.24.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2020. 01.26.




Cardio.>Arrhytmia. Atrial Fibrillation Mapping. HD Grid Catheter SE (Sensor Enabled).
EU Approval Date : 2017. 12.
USA Approval Date: 2018. 05.03.
(*) Company; Patent: TradeMark & Web-
Site Available on Request.
UpDate: 2019. 03.01.




Cardio.>Arrhytmia. Atrial Flutter (AFl). Treat.: Irrigated Ablation Catheter SE (Sensor Enabled).
USA Approval Date: 2017. 03.01.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 03.07.




Cardio.>BioTherapeutic Delivery System. Percutaneous Catheter Delivery System.
Local Delivery of Cell and Gene based Therapies to treat Heart Failure, Myocardial Infarction, Ischemia, and Cardiac Conduction Disorders
EU CE Mark Renewal Date: 2019. 10.08
till 2024. 05.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2020. 04.29.




Cardio.>Coronary Artery Disease. Calci- fied Plaque. Treat.: Lithotripsy.
Integrates Angioplasty Balloon Catheter
devices with the Calcium-disrupting
power of sonic pressure waves known as
lithotripsy.
EU Approval Date: 2017. 05.15.
EU Launch Date: 2018. 05.21.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 11.03.




Cardio.>Coronary Artery Disease. DIAG.:
GuideWire Fractional Flow Reserve (FFR)
During Percutaneous Coronary Interven-
tion (PCI).
Indications:
to direct a catheter through a blood vessel and to measure blood pressure
in the heart and in the coronary blood vessels.
Patient Outcomes Improvement>
>over Angiography alone.
EU Launch Date: 2016. 05.18.
(*) Company; Patents; TradeMark & Web-
Sites Available on Request.
UpDate: 2019. 03.12.




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.>Ostial System Dual-Balloon Angioplasty Catheter.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2018. 12.31.




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.


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