Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017.

According to the press release, Abbott produces the Confirm RxTM ICM, which is marketed as the slimmest ICM available. Pictured on the right, Abbott states that the Confirm RxTM is designed to continuously monitor a patient’s heart rhythm and proactively transmit information via the myMerlinTM mobile app, thereby allowing physicians to follow their patients remotely and ICMaccurately diagnose arrhythmias.  As noted on the Confirm RxTM webpage, the ICM is placed by a physician under local anesthesia by making a small incision in the pectoral region, inserting the ICM under the skin using an insertion tool, and then closing the incision. “Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator,” said Georg Nölker, M.D. in prepared remarks.  Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark approval.

According to Abbott, the myMerlinTM mobile app makes it easy for patients to stay connected to their physicians.  A listing of the product features from the Confirm RxTM product website includes:

  • Transmit nightly data reports automatically simply by being in range of the smartphone;
  • Manually record patient symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate;
  • Confirm patient data was transmitted to their physician;
  • Automatic alerts when they have missed a scheduled transmission;
  • Offers secure transmission of patient data.

Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses, views these results as a step forward in ICM technology, stating:

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.

Dr. Christopher Piorkowski, said to be one of the first physicians to implant the Confirm RxTM ICM, stated:

The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF.

As reported by the press release, the Confirm RxTM ICM is available in select European countries, with full European release expected during the second quarter of 2017.  It further states that the device is currently under review by the U.S. Food and Drug Administration.

Albert Sueiras
Albert Sueiras is an associate in the Orange County office. Mr. Sueiras received his bachelor's degree in Biomedical Engineering, cum laude, from the University of Miami and also received his master's degree in Biomedical Engineering, cum laude, from the University of Florida. He received his J.D. from the University of Florida Levin College of Law, where he was a member of Phi Delta Phi. During law school, Mr. Sueiras externed at the United States Patent and Trademark Office within Art Unit 3733, focusing on patent examination of orthopedic surgical instrumentation. Mr. Sueiras also participated in a patent prosecution externship at Banyan Biomarkers, Inc. in Alachua, Florida, a firm specializing in the discovery of biomarkers for traumatic brain injury and neurotoxicity. Mr. Sueiras worked as a summer associate at the firm in 2015 and joined the firm in 2016.
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