Here is another example of how the diagnostic technologies used by anatomic pathology and clinical laboratories are evolving toward minute devices that deliver data wirelessly to electronic health records and healthcare databases for access by physicians and lab professionals

Anatomic pathologists and clinical laboratory managers keeping track of new implantable patient monitoring devices should find Abbott Laboratories’ (Abbott) recent technology release of great interest.

It’s an insertable cardiac monitor (ICM), also known as an implantable loop recorder, called Confirm Rx that, once implanted, can continuously monitor a patient’s heart rate and, using Bluetooth wireless technology, transmit collected data to physicians via a smartphone app. Abbott claims it is the “world’s first smartphone-compatible ICM.”

The laboratory’s website states, “The Confirm Rx ICM offers convenient, connected, and continuous monitoring for insight into your patients’ conditions and symptoms, including syncope, palpitations, and [atrial fibrillation] before or after ablation therapy and cryptogenic stroke—with fewer interruptions to their daily lives.”

Healthcare providers can implant Confirm Rx underneath the skin of a patient’s chest in just a few minutes using a simple insertion tool. The monitoring device is about the size of a small paper clip and has a two-year battery life. It provides physicians and their patients with an innovative way to identify and monitor abnormal heart rhythms or cardiac arrhythmias.

Transmitting ICM Data Using Smartphone App

Data collected by the Confirm Rx can be transmitted to a healthcare professional using the myMerlin for Confirm Rx smartphone app, developed by St. Jude Medical, which is now Abbott Laboratories (NYSE:ABT). No home-based transmitter, handheld activator, or additional equipment is required. However, individuals who use the Confirm Rx need to keep their smartphones within five feet of their bodies to ensure a continuous connection.

“Confirm Rx shows what we can do with cutting edge communication technology and the most advanced medical devices that provide new opportunities to improve patient care,” stated Avi Fischer, MD, Divisional VP Medical Affairs, and Medical Director for Cardiac Rhythm Management at Abbott, in a news release.

“By offering a device that uses Bluetooth wireless technology from the patient’s smartphone, we can help physicians easily and remotely diagnose potentially dangerous abnormal heart beats without requiring the patient to use a separate or cumbersome recording device,” Fischer concluded.

The myMerlin mobile app transmits its data to the Merlin.net Patient Care Network, where doctors and patients can simultaneously track symptoms, synchronize personal data, and view a transmission history.

“Prior to the evolution of this technology, the ability to monitor patients was really short-lived. But this allows the monitoring to continue and allows the patient to continue to live their lives unhindered,” noted Sean C. Beinart, MD, Cardiologist and Medical Director, Cardiovascular Research Washington Adventist Hospital, in an Abbott product release.

Sean-Beinart-MD-Abbott-Laboratories-Confirm-RX

“Whenever you’re dealing with rhythm problems in the heart, being able to identify risk can sometimes mean the difference between life and death. The key is finding out what happened: What’s the cause of your symptoms?” Sean C. Beinart, MD (above), FACC, FHRS, a Cardiologist and Medical Director, Cardiovascular Research Washington Adventist Hospital, stated in an Abbott Laboratories video. Click on this link to watch the video. (Caption and video copyright: Abbott Laboratories.)

Peace of Mind through Technology

According to Abbott’s website, up to 7.1 million people in the United States are living with irregular heartbeats. The stroke risk for these individuals is five times higher than the risk for those without arrhythmias. When properly diagnosed, the condition is highly treatable.

“The stakes are very high,” Beinart stressed. “What the Confirm Rx does is it gives both me and my patient peace of mind that we’ve got them covered.”

Abbott obtained the Confirm Rx device when it acquired St. Jude Medical last year. The US Food and Drug Administration (FDA) approved the device in October of 2017. The first implantation of the Confirm Rx device took place in November.

The feedback received from users regarding the Confirm Rx has been positive and has helped increase Abbott’s electrophysiology sales by 16% during the last quarter of 2017, Fischer told CNBC.

“The types of patients have varied from younger to older, and [the devices] are being implanted for a variety of conditions,” Fischer stated. “Sometimes it’s to diagnose or to rule something out.”

As more implantable diagnostic monitoring/reporting devices are brought to the market, it is expected that some will be designed to measure some of the same biomarkers used in the assays performed by clinical laboratories. As that happens, clinical labs will have opportunities to serve medical facilities, physicians, and patients in new and more timely ways.

These implantable diagnostic devices may also give medical laboratories another way to be of value in the collection, storing, analysis, and reporting of the data obtained by the monitors, along with other lab tests doctors may order.

—JP Schlingman

Related Information:

Medicine Is Moving from Implantables to ‘Chipables’

Heart Monitor Links Patients to Doctors Using the One Thing They’re Unlikely to Forget Their Phones

Abbott Launches the First and Only Smartphone Compatible Insertable Cardiac Monitor in the U.S.

Heart Monitoring, Everywhere You Go

Confirm Rx Patient Brochure (PDF)