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The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2.
Endologix, Inc.
TV-AB2380-N
In Commercial Distribution
- M701TVAB2380N1 ()
- Stent Graft Proximal Diameter
- Catheter Working Length
- Delivery System Outer Profile
- Integral Sheath Inner Diameter
- Covered Stent Graft Length
TV-AB2380-N
- Abdominal aorta endovascular stent-graft
The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution
- M701TVAB2380E1 ()
- Catheter Gauge: 14 French
- Outer Diameter: 23 Millimeter
TV-AB2380-E
- Abdominal aorta endovascular stent-graft
The TriVascular® Ovation iX™ Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal stent graft aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs and iliac extensions as required. The TriVascular Ovation iX Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution
- M701TVAB2080J1 ()
- Outer Diameter: 20 Millimeter
- Catheter Gauge: 14 French
TV-AB2080-J
- Abdominal aorta endovascular stent-graft
A multi-lumen device with two balloons mounted near the distal tip.
Zoll Circulation, Inc.
1027
In Commercial Distribution
- 00849111030007 ()
8700-000775-01
- Intravascular occluding balloon catheter, image-guided
LEAD 459888 ATTAIN PERFORMA USA
MEDTRONIC, INC.
459888
Not in Commercial Distribution
- 00643169169081 ()
- Length: 88.0 Centimeter
- Coronary venous pacing lead
LEAD 459878 ATTAIN PERFORMA USA
MEDTRONIC, INC.
459878
In Commercial Distribution
- 00643169169036 ()
- Length: 78.0 Centimeter
- Coronary venous pacing lead
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System.
The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader data
and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Endotronix, Inc.
100543-00
In Commercial Distribution
- 00850008997051 ()
- Implantable pulmonary artery pressure monitoring system
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System.
The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include:
• Interrogates the Cordella Sensor to verify proper working condition.
• Facilitates linking of component serial numbers to patient IDs.
• Calibrates the Cordella Sensor to a reference pressure at the time of implantation.
• Trains patient on optimal Reader placement post-procedure.
• Recalibrates the Cordella Sensor to a reference pressure post-implant.
• CalEQ is operated by Endotronix personnel only.
Endotronix, Inc.
100622-00
In Commercial Distribution
- 00850008997020 ()
- Implantable pulmonary artery pressure monitoring system
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System.
The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.
Endotronix, Inc.
100102-01
In Commercial Distribution
- 00850008997013 ()
- Implantable pulmonary artery pressure monitoring system
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System.
Cordella PA Sensor
The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex.
Delivery System
The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.
Endotronix, Inc.
100303-05
In Commercial Distribution
- 00850008997006 ()
- Implantable pulmonary artery pressure monitoring system