Medical Device Daily...April 19, 2016 article.....
Nowcardio a potential triple threat in ambulatory arrhythmia monitoring
By David Godkin, Staff Writer
Event Cardio Group Inc. is moving forward with its Canadian plan for commercializing Nowcardio, an advanced ambulatory arrhythmia monitoring system - this following the device’s certification to Canadian Medical Devices Conformity Assessment System standards. Event Cardio has also signed an agreement with Newmarket, Ontario’s The Stornoway Group Inc. to accelerate regulatory approvals in Europe, Australia and the U.S.
“We’re absolutely thrilled,” Event Cardio President and CEO John Bentivoglio told Medical Device Daily. “We’ve been working on this for four years and we believe we have the best device for ambulatory arrhythmia monitoring available in the world today.”
Bentivoglio stakes his claim on the combination of three distinct technologies in Nowcardio to monitor, record, transmit and analyze a patient’s cardiac data: an event recorder stores brief recordings of ECG activity when activated by the patient in response to symptoms. Mobile cardiac outpatient telemetry or “loop recording” provides several days of ECG monitoring in patients with symptoms suggestive of a significant cardiac arrhythmia.
Meantime, a Holter monitor records cardiac events likely to occur within 24 or 48 hours to record events - usually too short to capture infrequent symptoms of arrhythmia. By combining Holter with event and telemetry recording, Nowcardio “can do it all,” said Bentivoglio, monitoring and recording a patient’s cardiac status for up to thirty days.
“Most important, though, is that all of that is done in real time,” Bentivoglio said. “You could be in Toronto and your doctor in Ottawa and he could have immediate access to whatever test is underway at that moment.” Cardiac data from a single-lead ECG patch worn by the patient is transferred via Bluetooth and fob to a remote computerized data monitoring center for interpretation by hospital staff.
Also critical to ambulatory arrhythmia monitoring is patient acceptance – precisely where Holter monitors fall down, Event Cardio’s Chief Engineer Richard Smith explained to Medical Device Daily. “A lot of patients won’t keep it on because there are a lot of leads, a lot of wires and it’s uncomfortable. So you don’t get the kind of diagnostic yield required.” By reducing the weight and electronic complexity, the single-lead Nowcardio is worn more comfortably by patients, he said, to produce a greater data yield.
No one is more sensitive to his patients’ comfort than Yaariz Khaykin, an electrophysiologist at Southlake Regional Health Center in Newmarket, Ontario. “My patients come back to me and say ‘please, please don’t order another two week Holter.’” But the verdict is still out, he told Medical Device Daily, on single lead ECGs. “It makes sense, depending upon the patients’ willingness to have anything attached to their skin for prolonged periods of time.”
Peter Zimetbaum, Associate Chief and Director of Clinical Cardiology Beth Israel Deaconess Medical Center, contrasts the Holter monitor with the Zio Patch made by San Francisco’s Irhythm Technologies Inc. The lightweight, single-use cardiac event patch continuously records heartbeats for up to thirty days, compared to twenty-four to forty-eight hours using the Holter.
“Both of these devices provide comprehensive arrhythmia analysis,” he told Medical Device Daily, “but neither provides that data in real time to the physician. The Zio patch has the distinctive advantage of comfort for the patient with a longer period of surveillance.”
Dublin-based Medtronic plc’s Seeq Mobile Cardiac Telemetry is also a simple peel-and-stick sensor attached to the patient’s chest, but has real time monitoring ability. There, the impediment could be cost: “The Seeq is expensive, costing about US$700,” Zimetbaum said. “Event recorders and even the Zio patch are only US$200. So there’s a big cost differential when you have these more advanced devices.”
How might Nowcardio compare once it’s on the market? That’s still to be determined. So far, money coming in to Event Cardio Group has been for developing the product, i.e. a second tranche of C$325,000 CAD from a group of individuals who are party to C$1.5 million in subscription agreements disclosed on Feb. 17, 2016. To date, the group has advanced C$660,000 of the C$1.5 million. According to company literature this second tranche of funds will largely be used to further the commercialization of the Nowcardio.
