Device Description : Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller

Device Description : Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us (View more) 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. (View less)

Device Description : Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC (View more) 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. (View less)

Device Description : Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Cathet (View more) 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. (View less)

Device Description : The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, dispo (View more) 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. (View less)

Device Description : TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas (View more) 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. (View less)

Device Description : TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas (View more) 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. (View less)

Device Description : TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravas (View more) 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. (View less)

Device Description : The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravasc (View more) 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. (View less)

Device Description : TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular (View more) 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. (View less)