A paperclip-sized revolution in cardiac electrophysiology is afoot in a bright white lab at Abbott Laboratories in Sylmar, where the world’s first Bluetooth- and smartphone-enabled implantable cardiac monitor are coming off the assembly line. Formerly the home of St. Jude Medical, which Abbott bought last year, the facilities now serve as the center of Abbott’s cardiac rhythm business, Cardiac Rhythm Management Medical Director Dr. Avi Fischer said. “This is the headquarters, if you will, for (our implantable cardiac rhythm device) activities,” Fischer said. The company’s latest invention, Confirm Rx, is mounted with a Bluetooth sensor that works with a smartphone app to record and send data about a patient’s heart rhythm to her physician. With a battery that lasts up to two years and a symptom tracker on the app, it’s designed to help doctors diagnose patients with cardiac arrhythmias that take place every once in a while. “We’ve taken a lot of uncertainty out of it just by using what we’re all used to using and carrying it around with us every day,” Fischer said. Al Mann to Abbott The technology that makes the Confirm Rx device possible stems in part from the legendary entrepreneur behind several of the Valley region’s most valuable biotechnology companies: Al Mann. In 1965, Mann founded Pacesetter Systems Inc., which manufactured pacemakers developed with Mann’s assistance in a physics laboratory at Johns Hopkins University. He sold the firm in 1985 to Munich-based Seimens, which sold it to St. Jude Medical in 1994. St. Jude was acquired by Abbott last January for $25 billion. Abbott’s Sylmar facilities are home to the company’s cardiac arrhythmias sector, which is part of its larger heart failure division. The site is centered on research, development and manufacturing of implantable devices for diagnosing and treating cardiac conditions. Though the division has other domestic manufacturing facilities in Arizona, South Carolina and Minnesota, about 70 percent of its research and development activities take place in Sylmar, Vishnu Charan, divisional vice president of operations, said. “We have a good presence of manufacturing (in Sylmar),” he said. “Most of the R&D for all of our cardiac (rhythm management) products happens over here.” Those products include pacemakers, leads, defibrillators and implantable cardiac monitors such as the Confirm Rx. Technicians assemble, test and package the devices with machines and, in some cases, by hand. The Confirm Rx device fills a void in the market of implantable cardiac monitoring devices, and not just because it’s high-tech. Similar devices are designed to track arrhythmias that occur over 24- to 48-hour periods, while the Confirm Rx can be worn for as long as two years. That’s a critical differentiation for diagnosing heart conditions in patients who experience arrhythmias every once in a while rather than within a short period, Fischer explained. “Unlike an Apple Watch or a Fitbit, there are very clear indications for this device,” he said. Patients who get it have typically undergone a battery of diagnostic tests that have not been able to catch their arrhythmia. The endurance of Confirm Rx’s battery allows their heart rhythm to be tracked for long periods of time. “That, along with the smartphone element, has really changed this into a very state-of-the-art kind of device,” Fischer said. Phone advantage The fact that the Confirm Rx can communicate with a smartphone is an advantage, Dr. Thomas Deering, chief quality officer of the Piedmont Heart Institute in Atlanta, told the Business Journal in an email. He and his colleagues have firsthand experience using the device, along with competitors. “The rhythm information obtained can then be sent from the smartphone at a scheduled time with confirmation, obviating the need for an additional transmission device in the home,” Deering said. Other devices, including Abbott’s older cardiac monitors, required separate equipment to record and send information about the patient’s heart rhythm to a physician. Confirm Rx’s smartphone application, called myMerlin, records data on the patient’s heart rhythm constantly. If a patient is aware of an arrhythmia when it happens, she can opt to send that information to her physician immediately along with notes about the symptoms. Otherwise, the data is sent at a scheduled time. “If the patient has one of these implanted and they have an event that’s asymptomatic, the device will still record it and transmit it (later),” Fischer said. “There’s the automated transmission and the patient-triggered transmission – you can do both.” Abbott involved a wide range of patients in the process of developing the app, he added. The company surveyed potential users, from teens to patients in their late 80s, to get feedback on the user experience. “We didn’t want a device and an app that was good for young people but not for old people,” Fischer explained. “We really put a lot of thought into designing the app.” One risk with all implantable cardiac monitors is false positive or negative recordings, Deering noted. While technical improvements have made such errors less likely, they still persist. “An excessive number of false positive recordings could overwrite real arrhythmias,” he wrote. The platform attached to the Confirm Rx attempts to circumvent these issues by making it easy for physicians to program specific parameters that constitute a cardiac event. The symptom-tracking feature on the app helps rule out conditions as well, Fischer explained. “Sometimes the diagnostic capabilities are not just finding things, but also ruling things out,” he said. “Many of us can attest to the patient that comes in and says they felt terrible, lightheaded and passed out, but their heart rhythm is stable.” Market value The market for implantable cardiac monitors is expected to reach $682 million by 2023, driven by demand for small, easily implanted devices to diagnose heart conditions as well as epilepsy, according to Dublin-based research firm Research and Markets. The U.S. Food and Drug Administration approved the Confirm Rx for sale in October 2017. Abbott declined to disclose the price per unit. But while it is a profitable product, according to Charan, it might be too soon to tell if the momentum will last. The health industry’s move toward a compensation model that emphasizes health outcomes over procedure volumes means that the patients who use Confirm Rx will need to show significant improvement for hospitals to justify the expense. “There’s always a question about health economics, and whether we are providing the right therapy and making sure that we are helping society,” Charan said. “Institutions are not going to implant our product if they are not going to provide the right monetary economic benefit.” Though Abbott has no immediate plans to expand its physical presence in Sylmar, it has been adding workers. The company has increased its workforce by between 5 and 10 percent over the past year, Charan said. “We’re making sure we have the right talent in the right place,” he added.