Koronar TM - NTM Devices
TMFrom Indigenous Idea to Newtech SolutionKoronar
TMStent MaterialDelivery system usable lengthDelivery System Y-Adaptor PortsStent delivery balloonBalloon inflation pressureGuiding catheter inner diameterGuide WireStrut Thickness (µm)Polymer Bio-DegradationPushability and TrackabilityStent RecoilForeshorteningStent architectureSurgical Grade Cobalt chromium (L605), laser cut from seamless tubing in a serpentine patterncoated with a polymer and Sirolimus mixture.140cmSingle access port to the inflation/deflation lumen. A guidewire exit port is located at 25cm fromthe tip. Designed for guidewire 0.014” (0.36mm).Nylon balloon, nominally 1.0mm longer than stent, mounted stent length and location is definedby radio opaque GOLD 18K marker at proximal and distal to stent.Nominal inflation pressure: 8 atm ,Rated burst pressure: 16 atm*.5 Fr(1.4mm) Compatible0.014 inch60100% 6-7 WeeksExcellent 6% 2%Hybrid Cell Design with Non-Linear linksPercentage of Drug ReleaseKoronar has proven drug release kinetics Initial Burst Release of 40%-50% Sirolimus in the first week followed by sustained releaseupto 40-48 days to maintain therapeutic sirolimus drug concentration to optimize the anti tissue proliferative action.120
TMThe Koronar Sirolimus eluting stent system is a combination product comprised of two regulated components: a device (a coronary stentsystem) and a drug product (a formulation of Sirolimus contained in a polymer coating) pre mounted on balloon catheter between twoGOLD 18K radio opaque marker bands.The component is coated on the stent. This coating consists of a blend of sirolimus drug (the active ingredient) and biodegradablepolymers (the inactive ingredient).Sirolimus is a Macrocyclic lactone produced by Streptomyces hygroscopicus.The chemical name of Sirolimus is (3S, 6R, 7E, 9R, 10R, 12 R, 14S, 15E, 17E, 19 E, 21S, 23S, 26R, 27R, 34aS) -9, 10, 12, 13, 14, 21,22, 23, 24, 25, 26, 27, 32, 33, 34 ahexadecahydro 9, 27 dihydroxy - 3 - [(1R) - 2 - [(1S, 3R, 4R) - 4 - hydroxyl - 3 ethoxycyclohexyl] - 10,21- dimethoxy- 6, 8, 12, 14, 20, 26- hexamethyl - 23, 27 - epoxy - 3H - pyrido [2, 1 - c] [1, 4] oxaazacyclohentriacontine - 1, 5, 11, 28, 29(4H, 6H, 31H) – pentone.Its molecular formula is C51H79NO13 and M.Wt. is 914.2.Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile& has a melting temperature of approximately 183- 185 C. Sirolimus belongs to a class of therapeutic agents known as macro cycliclactones or macrolides. It is a cytostatic drug and an immunosuppressant.It inhibits cell motility by suppression of m-TOR mediated 56K1 and 4E-BP1 pathways.It inhibits T-Lymphocyte activation and proliferation occurring in response to antigen and cytokine. It also inhibits antibody production. Itdemonstrates anti- proliferative activities.PolymerThe inactive ingredient of the coating consists of a blend of lactide and glycolide based biodegradable polymers.These polymers control the drug release kinetics and they degrade as the drug is released from the stent.*Nominal Pressure**RBP (Rated Burst Pressure)
TMManufacturer :stent@ntmdevices.comMfg. Lic. No. :786-B(H)Document No: NTM/BR/01Revision - 00
TMCoherentFrom Indigenous Idea to Newtech SolutionWith Biodegradable Polymerwww.ntmdevices.com
TMCoherentSirolimus Eluting Coronary Stent SystemCoherent Sirolimus Eluting Coronary Stent SystemStent MaterialDelivery System usable lengthDelivery System Y Adaptor PortsStent Delivery BalloonBalloon Infiation pressureGuiding Catheter inner diameterGuide WireStrut Thickness (μm)Polymer Bio-DegradationPushablity and TrackablityStent RecoilForeshorteningStent architectureImplantable Cobalt Chromium (L605), laser cut seamless tubing in a serpentinepattern coated with a polymer and Sirolimus mixture.140 cmSingle access port to the inflation/deflation lumen. A guide wire exit port is located at25 cm from the tip. Designed for guidewire 0.014" (0.36 mm)Nylon balloon, nominally 1.0 mm longer than stent, mounted stent length andlocation in defined by radiopaque Gold 18K marker at proximal and distal to stent.Nominal inflation Pressure : 8 atm*Rated burst pressure : 16 atm5 Fr. (1.40mm) Compatible0.014 inches75 5100 % 7-8 weeksExcellent 6% 2%Hybrid cell design with Non-Linear links*8 atm for 2.25 to 3.00 vessel and length 8 to 26 mm9 atm for 3.25 to 4.50 vessel and length 30 to 54 mmwithGold MarkerbandProven Drug Release KineticsPercentage of Drug ReleaseCoherent has proven drug release kinetics Initial Burst Release of 30% to 40% Sirolimus in the first week followed by sustainedrelease upto 50-60 days to maintain therapeutic sirolimus drug concentration to optimize the anti tissue proliferative action.Days
TMCoherentSirolimus Eluting Coronary Stent SystemThe Coherent Sirolimus eluting stent system is a combination product comprised of two regulated components : a device (acoronary stent system) and a drug product (a formulation of Sirolimus contained in a polymer coating) pre mounted a ballooncatheter between two GOLD radio opaque marker bands.Stent Diameter (measured at 37.5 C tolerance 0.10 mm)Pressure Bar4678*910111213141516**1718202.25mm2.00 mm2.10 mm2.15 mm2.23 mm2.25 mm2.28 mm2.30 mm2.32 mm2.35 mm2.39 mm2.41 mm2.43 mm2.45 mm2.47 mm2.48 mm2.50mm2.30 mm2.35 mm2.40 mm2.49 mm2.51 mm2.54 mm2.59 mm2.62 mm2.65 mm2.67 mm2.70 mm2.72 mm2.75 mm2.79 mm2.81 mm2.75mm2.54 mm2.60 mm2.65 mm2.75 mm2.78 mm2.80 mm2.86 mm2.89 mm2.92 mm2.95 mm2.98 mm3.01 mm3.04 mm3.08 mm3.12 mm3.00mm2.75 mm2.80 mm2.90 mm2.99 mm3.02 mm3.04 mm3.10 mm3.14 mm3.18 mm3.20 mm3.22 mm3.26 mm3.30 mm3.35 mm3.40 mm3.50mm3.30 mm3.39 mm3.42 mm3.45 mm3.48 mm3.51 mm3.62 mm3.66 mm3.70 mm3.74 mm3.78 mm3.80 mm3.82 mm3.86 mm3.89 mm4.00mm3.80 mm3.85 mm3.89 mm3.98 mm4.00 mm4.02 mm4.12 mm4.16 mm4.20 mm4.24 mm4.27 mm4.30 mm4.32 mm4.36 mm4.40 mm4.50mm4.25 mm4.30 mm4.40 mm4.49 mm4.52 mm4.55 mm4.58 mm4.60 mm4.65 mm4.68 mm4.72 mm4.75 mm4.78 mm4.81 mm4.85 mm*Nominal Pressure ; ** Rated Burst Pressure. # For stent size above 34 mm , kindly refer compliance chart on the outer label.Drug Component DescriptionCoherent Sirolimus stent is coating consists of a blend of sirolimus drug (the active ingredient) and biodegradable polymers(the inactive ingredient). Sirolimus is a Macrocyclic lactone produced by steptomyces hygroscopicus.The chemical nameof sirolimus (also known as rapamycin) is -epoxy-3H-pyrido[2,1-c ][1,4] pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2.Structural formula of sirolimus3D Stick model
TMCoherentSirolimus Eluting Coronary Stent SystemOrderding InformationNT/CS/22508Length of StentDiameter of stent 225 is 2.25 mmCS is Coherent StentNT is Newtech Medical DeviceStent DiameterLength08 mm12 mm14 mm18 mm22 mm26 mm30 mm34 mm38 mm42 mm46 mm50 mm54 mm2.25 mm2.50 mm2.75 mm3.00 mm3.50 mm4.00 mm4.50 45054For all Newtech Medical Devices ProductsKindly scanManufacturer :Newtech Medical Devices14/5 Mathura Road, Faridabad, Haryana 121003, INDIA.stent@ntmdevices.comwww.ntmdevices.comMfg Lic. No. 786-B(H)Doc/Rev. No. NTM/BR/01 / 00www.ntmdevices.comDoc/Rev. No. NTM/S/PKG/004-00
InsistentFrom Indigenous Idea to Newtech SolutionTM
InsistentTMSirolimus Eluting Coronary Stent SystemInsistent Sirolimus Eluting Coronary Stent SystemStent MaterialDelivery System usable lengthDelivery System Y Adaptor PortsStent Delivery BalloonBalloon Infiation pressureGuiding Catheter inner diameterGuide WireStrut Thickness (μm)Polymer Bio-DegradationPushablity and TrackablityStent RecoilForeshorteningStent architectureImplantable Cobalt Chromium (L605), laser cut seamless tubing in a serpentinepattern coated with a polymer and Sirolimus mixture.140 cmSingle access port to the inflation/deflation lumen. A guide wire exit port is located at25 cm from the tip. Designed for guidewire 0.014" (0.36 mm)Nylon balloon, nominally 1.0 mm longer than stent, mounted stent length andlocation in defined by radiopaque Gold 18K marker at proximal and distal to stent.Nominal inflation Pressure : 8 atm*Rated burst pressure : 16 atm5 Fr. (1.40mm) Compatible0.014 inches65 5100 % 7-8 weeksExcellent 6% 2%Hybrid cell design with Non-Linear links*8 atm for 2.25 to 3.00 vessel and length 8 to 26 mm9 atm for 3.25 to 4.50 vessel and length 30 to 54 mmwithGold MarkerbandProven Drug Release KineticsPercentage of Drug ReleaseInsistent has proven drug release kinetics Initial Burst Release of 30% to 40% Sirolimus in the first week followed by sustainedrelease upto 50-60 days to maintain therapeutic sirolimus drug concentration to optimize the anti tissue proliferative action.Days
InsistentTMSirolimus Eluting Coronary Stent SystemThe Insistent Sirolimus eluting stent system is a combination product comprised of two regulated components : a device (acoronary stent system) and a drug product (a formulation of Sirolimus contained in a polymer coating) pre mounted a ballooncatheter between two GOLD radio opaque marker bands.Stent Diameter (measured at 37.5 C tolerance 0.10 mm)Pressure Bar4678*910111213141516**1718202.25mm2.00 mm2.10 mm2.15 mm2.23 mm2.25 mm2.28 mm2.30 mm2.32 mm2.35 mm2.39 mm2.41 mm2.43 mm2.45 mm2.47 mm2.48 mm2.50mm2.30 mm2.35 mm2.40 mm2.49 mm2.51 mm2.54 mm2.59 mm2.62 mm2.65 mm2.67 mm2.70 mm2.72 mm2.75 mm2.79 mm2.81 mm2.75mm2.54 mm2.60 mm2.65 mm2.75 mm2.78 mm2.80 mm2.86 mm2.89 mm2.92 mm2.95 mm2.98 mm3.01 mm3.04 mm3.08 mm3.12 mm3.00mm2.75 mm2.80 mm2.90 mm2.99 mm3.02 mm3.04 mm3.10 mm3.14 mm3.18 mm3.20 mm3.22 mm3.26 mm3.30 mm3.35 mm3.40 mm3.50mm3.30 mm3.39 mm3.42 mm3.45 mm3.48 mm3.51 mm3.62 mm3.66 mm3.70 mm3.74 mm3.78 mm3.80 mm3.82 mm3.86 mm3.89 mm4.00mm3.80 mm3.85 mm3.89 mm3.98 mm4.00 mm4.02 mm4.12 mm4.16 mm4.20 mm4.24 mm4.27 mm4.30 mm4.32 mm4.36 mm4.40 mm4.50mm4.25 mm4.30 mm4.40 mm4.49 mm4.52 mm4.55 mm4.58 mm4.60 mm4.65 mm4.68 mm4.72 mm4.75 mm4.78 mm4.81 mm4.85 mm*Nominal Pressure ; ** Rated Burst Pressure. # For stent size above 34 mm , kindly refer compliance chart on the outer label.Drug Component DescriptionInsistent Sirolimus stent is coating consists of a blend of sirolimus drug (the active ingredient) and biodegradable polymers(the inactive ingredient). Sirolimus is a Macrocyclic lactone produced by steptomyces hygroscopicus.The chemical nameof sirolimus (also known as rapamycin) is -epoxy-3H-pyrido[2,1-c ][1,4] pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2.Structural formula of sirolimus3D Stick model
InsistentTMSirolimus Eluting Coronary Stent SystemOrderding InformationNT/IS/22508Length of StentDiameter of stent 225 is 2.25 mmIS is Insistent StentNT is Newtech Medical DeviceStent DiameterLength08 mm12 mm14 mm18 mm22 mm26 mm30 mm34 mm38 mm42 mm46 mm50 mm54 mm2.25 mm2.50 mm2.75 mm3.00 mm3.50 mm4.00 mm4.50 45054For all Newtech Medical Devices ProductsKindly scanManufacturer :Newtech Medical Devices14/5 Mathura Road, Faridabad, Haryana 121003, INDIA.stent@ntmdevices.comwww.ntmdevices.comMfg Lic. No. 786-B(H)Doc/Rev. No. NTM/BR/01 / 00Doc/Rev. No. NTM/S/PKG/004-00
EvroPlusTMEverolimus Eluting Coronary Stent Systemwww.ntmdevices.com
EvroPlus Everolims Eluting Coronary Stent SystemStent MaterialDelivery System usable lengthDelivery System Y Adaptor PortsStent Delivery BalloonBalloon Infiation pressureGuiding Catheter inner diameterGuide WireStrut Thickness (μm)Polymer Bio-DegradationPushablity and TrackablityStent RecoilForeshorteningStent architectureImplantable Cobalt Chromium (L605), laser cut seamless tubing in a serpentinepattern coated with a polymer and Everolimus mixture.140 cmSingle access port to the inflation/deflation lumen. A guide wire exit port is located at25 cm from the tip. Designed for guidewire 0.014" (0.36 mm)Nylon balloon, nominally 1.0 mm longer than stent, mounted stent length andlocation in defined by radiopaque Gold 18K marker at proximal and distal to stent.Nominal inflation Pressure : 8 atm*Rated burst pressure : 16 atm5 Fr. (1.40mm) Compatible0.014 inches60100 % 7-8 weeksExcellent 6% 2%Hybrid cell design with Non-Linear linksEvroPlus has proven drug release kinetics Initial Burst Release of 30% to 40% Evrolimus in the first week followed by sustainedrelease upto 48-50 days to maintain therapeutic Evrolimus drug concentration to optimize the anti tissue proliferative action.
4.00mm4.50 3.123.403.894.404.85
Stent DiameterLength08 mm12 mm14 mm18 mm22 mm26 mm30 mm34 mm38 mm42 mm46 mm50 mm54 mm2.25 mm2.50 mm2.75 mm3.00 mm3.50 mm4.00 mm4.50 45054Newtech Medical Devices
Newtech Medical Devices 14/5 Mathura Road, Faridabad, Haryana 121003, INDIA. stent@ntmdevices.com www.ntmdevices.com Mfg Lic. No. 786-B(H) Coherent Sirolimus Eluting Coronary Stent System Orderding Information NT/ /CS22508 Length of Stent Diameter of stent 225 is 2.25 mm CS is Coherent Stent NT is Newtech Medical Device TM www.ntmdevices.com
How to Export NTM Maps to Visio Network Topology Mapper works with Visio 2007, 2010, 2012, and 2013. To export to Microsoft Visio , click 'File' on the main menu, select 'Export' and choose 'Visio' from the available format options. After the discovery process is complete, rearrange your map the way you want it to look.
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Class Is/Im/Ir devices 2 Class IIa devices 4 Class IIb Annex VIII rule 12 devices 8 Class IIb implantable – Well-Established Technologies (WET) 10 Class IIb non-implantable non rule 12 devices (non WET) 10 Class IIb implantable devices (excluding WET) 14 Class III non-implantable devices 16 Class III implantable devices 18 Custom-made Class III implantable .
protocols and in identifying patients with potential M. chimaera infections with exposure to these devices. (Received 16 June 2021; accepted 14 August 2021) Mycobacterium chimaera is a slow-growing nontuberculous mycobacteria (NTM) and a member of the Mycobacterium avium complex (MAC). M. chimaera is commonly found in the environ-
ISO 80369-6:2016 shall be described as ‘ISO 80369-6 devices’. Devices that use the Luer connector will be described as ‘Luer devices’. The ISO 80369-6:2016 standard refers to ‘neuraxial’ devices. However, devices for both central and peripheral neural routes are impacted by the standard. Hence, these
Apr 01, 2014 · hardware components are available for iOS devices. System Components (iOS Devices) 1 Case with LPM mounts for iPad (9.7-inch) 5th and 6th generation mobile devices 2 Case with LPM mounts for iPhone X and iPhone XS mobile devices 3 Case with LPM mounts for iPhone 7 and iPhone 8 mobile devices 4 Adhesive mounting plate 5 Lumify Power Module (LPM) 3
Classification Rules -MDR, Annex VIII MDR MDD Rules 1 -4: Non-invasive devices Rules 5 -8 : Invasive devices Rules 9 -13 : Active Devices Rules 14 -22 : Special rules Rules 1 -4 : Non-invasive devices Rules 5 -8 : Invasive devices Rules 9 -12 : Active devices Rules 13 -18 : Special rules
3 CLEFS The clef, a symbol that sits at the leftmost side of the staff, specifies which lines and spaces belong to which notes. In a sense, the clef calibrates or orients the staff to specific notes. The three most common clefs are: The Treble clef for high range notes The Bass clef for low range notes The Alto clef for middle range notes The Treble clef (also called the G Clef because it .
