- Medtronic on Tuesday said it received FDA 510(k) clearance and CE marking for its Linq II insertable cardiac monitor that can be programmed remotely by a patient's physician. The company plans to launch the device in the U.S. and European markets later this summer.
- The device is designed for long-term monitoring of patients with abnormal heart rhythms who infrequently experience symptoms such as dizziness, palpitations, fainting and chest pain.
- Medtronic's marketing authorization news comes less than two weeks after Boston Scientific announced 510(k) clearance for its LUX-Dx insertable cardiac monitor to detect arrhythmias. Like Medtronic's device, the Boston Scientific system can be adjusted remotely.
Remote monitoring and programming capabilities for medical devices have gained a new level of attention in the COVID-19 era by reducing the need for as much in-person interaction with doctors. Medtronic CEO Geoff Martha has called such features critical for devices and asserted that the company is well positioned to take advantage of hospitals' growing demand for the functions, particularly as providers work to reduce their employees' exposure to the virus.
In addition to remote programming, the Linq II device allows patients to choose between two monitoring avenues. Patients can use their smartphones to automatically transfer device data with a mobile app that enables secure communication via Bluetooth, or they can transmit device data via a home communicator.
Patient data generated through continuous monitoring can aid physicians in the diagnosis and management of chronic cardiac arrhythmias such as atrial fibrillation. Medtronic said the Linq II system can also detect premature ventricular contraction, which is an extra, abnormal heartbeat that begins in the ventricles and disrupts the heart rhythm.
The latest version fo the device, described as being one-third the size of a AAA battery, has better accuracy in detecting abnormal heart rhythms as well as improved longevity of 4.5 years, Medtronic said. The company claims the longevity of its Reveal Linq insertable cardiac monitor is up to three years. Medtronic also touted low published rates of false atrial fibrillation detection and a reduction for physicians in time spent reviewing monitor data transmissions as benefits of the new device.
In addition to Boston Scientific, Medtronic is also competing against Abbott, with its Confirm Rx system, in the market for insertable cardiac monitors. Newcomer Boston Scientific has valued the market at about $750 million.
Medtronic's Martha said in May that the pandemic did not appear to be affecting the authorization process for products undergoing U.S. regulatory review. The company gained FDA approval in June for its Percept deep brain stimulator that can record a patient's brain signals while delivering treatment for conditions such as Parkinson's disease, epilepsy and obsessive-compulsive disorder. Medtronic is awaiting FDA decisions on devices including the InterStim Micro sacral nerve stimulator, a treatment for incontinence, and for the MiniMed 770G hybrid closed loop insulin pump system.