TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravas
TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32).Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, dispo
The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, disposable coronary catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The dual-modality intravascular imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer and laser-based near infrared spectroscopy (NIRS) for simultaneous acquisition of vessel structure and plaque composition data— a single catheter, a single pullback, two sets of data. The Dualpro™ IVUS+NIRS Imaging Catheter features a durable hydrophilic coating for improved deliverability.Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.The OKAY® II Y-Connector Set reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y-connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. (YOK0E)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. (YOK0E)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
OKAY II reduces blood loss during procedures through the use of a hemostatic val
OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.
Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC
Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC-C195-22) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us
Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubi
30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubing and 3 position stopcock for balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubi
30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubi
30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 3 position stopcock for angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
OKAY II reduces blood loss during procedures through the use of a hemostatic val
OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.
OKAY II reduces blood loss during procedures through the use of a hemostatic val
OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.
Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Cathet
Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Catheter Kit (TVC-C195-32) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™(TVC-MC9, TVC-MC9i, and properly configured TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and 50 MHz Extended Bandwidth ultrasonics for simultaneous acquisition of vessel structure and plaque composition— a single catheter, a single pullback, two sets of data. The Insight XB catheter features a 50MHz Extended Bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular
TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. This model of TVC Imaging System is designed to be installed in the catheterization laboratory and minimize usage of space. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32). Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravasc
The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated Extended Bandwidth IVUS imaging and NIRS (near infrared spectroscopy) technologies to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42). Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The NuVision Connector Cable is a non-sterile, reusable connector cable intended
The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system.
The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed
The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.
TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular
TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. This model of TVC Imaging System is designed to be installed in the catheterization laboratory and minimize usage of space. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32). Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravasc
The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated Extended Bandwidth IVUS imaging and NIRS (near infrared spectroscopy) technologies to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42). Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravas
TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32).Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging. Non-RoHsIndications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas
TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging. Non-RoHsIndications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, dispo
The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, disposable coronary catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The dual-modality intravascular imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer and laser-based near infrared spectroscopy (NIRS) for simultaneous acquisition of vessel structure and plaque composition data— a single catheter, a single pullback, two sets of data. The Dualpro™ IVUS+NIRS Imaging Catheter features a durable hydrophilic coating for improved deliverability.Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Cathet
Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Catheter Kit (TVC-C195-32) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™(TVC-MC9, TVC-MC9i, and properly configured TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and 50 MHz Extended Bandwidth ultrasonics for simultaneous acquisition of vessel structure and plaque composition— a single catheter, a single pullback, two sets of data. The Insight XB catheter features a 50MHz Extended Bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC
Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC-C195-22) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC
Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC-C195-22) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us
Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us
Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-
The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-
The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Veno
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Veno
Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter