Confirm Rx ICM approval
On May 8, 2017, Abbott Laboratories (ABT) announced the CE Marking (European Conformity) approval of the company’s Confirm Rx ICM (insertable cardiac monitor). ABT stock rose 0.09% that day. The news might also have had an impact on funds such as the Vanguard Value ETF (VTV), which holds approximately 0.75% of its total holdings in ABT.
Confirm Rx ICM is claimed to be the first smartphone-compatible ICM in the world and slimmer than other similar devices currently available. The device is available in select European countries. The full European launch is expected in 2Q17. In the United States, the device is currently under review. It was added to Abbott’s pipeline through the acquisition of St. Jude Medical in January 2017.
Confirm Rx ICM helps detect and monitor a patient’s heart rhythm through a mobile app (application) called myMerlin. The device’s data are uploaded wirelessly to the Merlin.net Patient Care Network. Remote cardiac monitoring without a bulky bedside or handheld transmitter is a first in the ICM market space. Medtronic’s (MDT) Reveal Linq ICM, which was approved in the United States and Europe on March 15, 2017, provides direct competition to the Confirm Rx ICM. The device wirelessly communicates data to the Medtronic CareLink network with a patient bedside monitor. Other major players in the cardiac monitoring market include Boston Scientific (BSX) and GE Healthcare, a subsidiary of General Electric (GE).
According to Abbott Laboratories, after the device was approved, implants took place in ten European countries, driven by the strong device adoption.
According to Mark D. Carlson, M.D., managing director and chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses, “Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance. The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.”
Next, let’s look at Abbott’s recent addition to its atrial fibrillation portfolio.