03.13.14
In this case, smaller is definitely better. Minneapolis, Minn.-based Medtronic Inc. has gained 510(k) clearance from the U.S. Food and Drug Administration (FDA) and the CE mark for its Reveal Linq insertable cardiac monitor (ICM) system. With these clearances, Medtronic commences the global launch of the tiny ICM which is approximately a third of the size of an AAA battery.
Medtronic claims the monitor allows physicians to continuously and wirelessly monitor a patient’s heart for up to three years, with 20 percent more data memory than its larger predecessor, Reveal XT.
In addition to its continuous and wireless monitoring capabilities, the system provides remote monitoring through the Carelink Network, which allows physicians to request notifications to alert them if their patients have had cardiac events. The Reveal Linq ICM is indicated for patients who experience symptoms such as dizziness, palpitation, syncope (fainting) and chest pain that may suggest a cardiac arrhythmia, and for patients at increased risk for cardiac arrhythmias.
“The Reveal Linq ICM monitor can help patients find answers to problems that may be heart-related without interrupting their lifestyle,” said Rod Passman, M.D., professor and associate director of cardiac electrophysiology at the Northwestern University Feinberg School of Medicine in Chicago, Ill. “The simplified procedure and insertion tools make the device faster and easier for physicians to implant, which may expand access to more patients needing long-term monitoring.”
Placed just beneath the skin through a small incision of less than 1 centimeter in the upper left side of the chest, the Reveal Linq ICM reportedly is often nearly invisible to the naked eye once inserted. The device is placed using a minimally invasive insertion procedure, hoped to simplify the experience for both physicians and patients. The Reveal Linq ICM is magnetic resonance-conditional, allowing patients to undergo magnetic resonance imaging (MRI) if needed.
“This miniaturized monitoring system is the result of many years of product development work from engineers focused on shrinking the size of medical devices while maintaining their power and improving benefits for patients,” said Pat Mackin, president of Medtronic’s Cardiac Rhythm Disease Management (CRDM) business and senior vice president. “This is game-changing technology for patients who need cardiac monitoring.”
The Reveal Linq system also includes the new Mycarelink patient monitor, a simplified remote monitoring system with global cellular technology that transmits patients’ cardiac device diagnostic data to their clinicians from nearly any location in the world.
“This is a technology that is going to help us reach more patients at risk for cardiac arrhythmias and help healthcare systems more efficiently manage difficult patient populations,” said Randy Lieberman, M.D., director of electrophysiology at Detroit Medical Center.
Following the Reveal Linq launch, Medtronic also announced the first U.S. implant of the equally small Micra transcatheter pacing system (TPS). The device successfully was implanted at New York University Langone Medical Center by Larry Chinitz, M.D., director of the university’s Heart Rhythm Center, as part of the Medtronic global pivotal clinical trial. The Micra TPS is an investigational device worldwide.
At one-tenth the size of a conventional pacemaker and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is attached to the heart wall and can be repositioned or retrieved if needed. The miniature device does not require the use of wires, known as “leads,” to connect to the heart. Attached to the heart via small tines, the pacemaker delivers electrical impulses that pace the heart through an electrode at the end of the device.
“With its small size and minimally invasive procedure, this technology represents the future of pacing,” said Chinitz. “Eliminating the need for a lead and pocket has the potential to reduce complications and recovery times compared to traditional pacemaker implants, which would be a major benefit to patients.”
In contrast to current pacemaker implant procedures, the Micra TPS implant does not require a surgical incision in the chest or the creation of a “pocket” under the skin. This eliminates a potential source of device-related complications, and any visible sign of the device.
“Micra TPS is an example of the investment we have made in disruptive technology, specifically the miniaturization of implantable cardiac devices,” Mackin said. “Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency. The FDA’s interactive review with CRDM was a key part of the [investigational device exemption] application approval process, and through our global Micra TPS clinical trial, we intend to generate evidence of these benefits to patients and clinicians throughout the world.”
The Micra TPS study is a single-arm, multi-center global clinical trial that will enroll up to 780 patients at approximately 50 centers. Initial results from the first 60 patients, followed up to three months, are expected in the second half of 2014.
Medtronic claims the monitor allows physicians to continuously and wirelessly monitor a patient’s heart for up to three years, with 20 percent more data memory than its larger predecessor, Reveal XT.
In addition to its continuous and wireless monitoring capabilities, the system provides remote monitoring through the Carelink Network, which allows physicians to request notifications to alert them if their patients have had cardiac events. The Reveal Linq ICM is indicated for patients who experience symptoms such as dizziness, palpitation, syncope (fainting) and chest pain that may suggest a cardiac arrhythmia, and for patients at increased risk for cardiac arrhythmias.
“The Reveal Linq ICM monitor can help patients find answers to problems that may be heart-related without interrupting their lifestyle,” said Rod Passman, M.D., professor and associate director of cardiac electrophysiology at the Northwestern University Feinberg School of Medicine in Chicago, Ill. “The simplified procedure and insertion tools make the device faster and easier for physicians to implant, which may expand access to more patients needing long-term monitoring.”
Placed just beneath the skin through a small incision of less than 1 centimeter in the upper left side of the chest, the Reveal Linq ICM reportedly is often nearly invisible to the naked eye once inserted. The device is placed using a minimally invasive insertion procedure, hoped to simplify the experience for both physicians and patients. The Reveal Linq ICM is magnetic resonance-conditional, allowing patients to undergo magnetic resonance imaging (MRI) if needed.
“This miniaturized monitoring system is the result of many years of product development work from engineers focused on shrinking the size of medical devices while maintaining their power and improving benefits for patients,” said Pat Mackin, president of Medtronic’s Cardiac Rhythm Disease Management (CRDM) business and senior vice president. “This is game-changing technology for patients who need cardiac monitoring.”
The Reveal Linq system also includes the new Mycarelink patient monitor, a simplified remote monitoring system with global cellular technology that transmits patients’ cardiac device diagnostic data to their clinicians from nearly any location in the world.
“This is a technology that is going to help us reach more patients at risk for cardiac arrhythmias and help healthcare systems more efficiently manage difficult patient populations,” said Randy Lieberman, M.D., director of electrophysiology at Detroit Medical Center.
Following the Reveal Linq launch, Medtronic also announced the first U.S. implant of the equally small Micra transcatheter pacing system (TPS). The device successfully was implanted at New York University Langone Medical Center by Larry Chinitz, M.D., director of the university’s Heart Rhythm Center, as part of the Medtronic global pivotal clinical trial. The Micra TPS is an investigational device worldwide.
At one-tenth the size of a conventional pacemaker and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is attached to the heart wall and can be repositioned or retrieved if needed. The miniature device does not require the use of wires, known as “leads,” to connect to the heart. Attached to the heart via small tines, the pacemaker delivers electrical impulses that pace the heart through an electrode at the end of the device.
“With its small size and minimally invasive procedure, this technology represents the future of pacing,” said Chinitz. “Eliminating the need for a lead and pocket has the potential to reduce complications and recovery times compared to traditional pacemaker implants, which would be a major benefit to patients.”
In contrast to current pacemaker implant procedures, the Micra TPS implant does not require a surgical incision in the chest or the creation of a “pocket” under the skin. This eliminates a potential source of device-related complications, and any visible sign of the device.
“Micra TPS is an example of the investment we have made in disruptive technology, specifically the miniaturization of implantable cardiac devices,” Mackin said. “Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency. The FDA’s interactive review with CRDM was a key part of the [investigational device exemption] application approval process, and through our global Micra TPS clinical trial, we intend to generate evidence of these benefits to patients and clinicians throughout the world.”
The Micra TPS study is a single-arm, multi-center global clinical trial that will enroll up to 780 patients at approximately 50 centers. Initial results from the first 60 patients, followed up to three months, are expected in the second half of 2014.