Search Results

The Jot Dx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Jot Dx™ ICM DM4500 System consists of the Jot Dx™ ICM Model DM4500 Implantable Device, Implant Tools (Incision tool Model DM3520 and Insertion tool Model DM3510), Confirm Rx ICM Accessory Kit DM3500A, Magnet, Clinician Programmer (Merlin PCS Programmer Model 3650), myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)), and Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator). The ICM is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability.

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as the following: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Confirm Rx™ ICM System consists of the following key features and components: Confirm Rx™ ICM Model DM3500 Implantable Device, Implant Tools (Incision tool model DM3520 and Insertion tool model DM3510), Confirm Rx ICM Accessory Kit DM3500A, Magnet, Clinician Programmer (Merlin PCS Programmer Model 3650), myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)), and Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator). The ICM is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability.

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Confirm RxTM ICM System consists of the following key features and components: - Confirm RxTM ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. - Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool are used to implant the device subcutaneously. - Magnet: The magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions). - Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information. - myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)): The mobile application provides the means for the patient to activate EGM recording in the Confirm Rx™ device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network. - Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net system allows physicians to remotely monitor and diagnose patients' cardiac events.

The Agilis HisPro Steerable Catheter With Electrodes is indicated to provide a pathway for delivery and support of transvenous devices within the chambers and vasculature of the heart and can be used for electrogram recording and stimulation.

The Agilis HisPro Steerable Catheter With Electrodes is a deflectable, slittable catheter with two distal tip electrodes. It serves as a delivery conduit for devices such as cardiac leads. The distal portion can be formed into a "U" shape, when fully deflected, to facilitate positioning of the tip at a desired location in the heart. The 10.5 Fr catheter has a braided shaft with a multi-durometer outer Pebax jacket. The catheter has a 7 Fr diameter lumen that allows for delivery of a 6Fr cardiovascular transvenous device, including a 6Fr pacing lead. The Agilis HisPro catheter's proximal handle consists of a rotating actuator with passive locking mechanism for deflecting the distal portion, a hemostasis valve for leak-proof delivery, and an integrated cable incorporating a 4-pin electrical connection for connecting to external electrical systems via a commercially available electrophysiology cable. The tip electrodes provide the ability to sense intracardiac electrogram (EGM) and pace when connected to the Merlin™ Pacing System Analyzer (PSA) or the WorkMate Claris™ Recording System. The sensing and pacing feature of the Agilis HisPro catheter provides the ability to identify the desired location in the heart. Accessories packaged for use with the Agilis HisPro catheter include dilator, guidewire for vascular access, cable adaptor pins for connection to the Merlin PSA via the electrophysiology cable, valve bypass tools for lead insertion, three-way stopcock and slitter. The catheter and the packaged accessories are provided as a sterile single-use device.

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Abbott Confirm RxTM (ICM) System consists of the following key features and components: - Confirm Rx™ ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. - Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously. - Model 3111 Magnet: SJM donut magnet, facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions). - Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information. - myMerlin™ Patient App (Model APP1000 (Android) and APP1001 (iOS)): The mobile application provides the means for the patient to activate EGM recording in the Confirm RxTM device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network. - Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net MN5000 system allows physicians to remotely monitor and diagnose patients' cardiac events.

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm RxTM ICM has not been specifically tested for pediatric use.

The Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include: - Patient-initiated triggering of EGM storage using the myMerlin™™ Patient App for mobile devices. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review. - Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals. - Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration. - The ability to identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable. - Remote care monitoring.