Biotronik’s heart failure prediction tech gains CE mark

GERMANY – Biotronik has announced the CE-mark approval and launch of HeartInsight, a remote heart failure (HF) management solution designed to identify patients at higher risk of HF decompensation early on.

HeartInsight will be presented for the first time at the European Heart Rhythm Association (EHRA) Congress next month.

Chief medical officer David Hayes remarked that “early identification of patients at higher risk for HF has the potential to improve outcomes, reduce hospital admissions and ultimately decrease overall costs while hopefully improving the patient’s quality of life.”

He added that “HeartInsight’s predictive alert allows clinicians to address problems before they turn into a clinical crisis.”

HeartInsight, according to Biotronik, predicts two out of every three HF hospitalizations and has an “industry-low false alert rate.”

The algorithm in the solution combines eight relevant HF parameters into a single predictive score and alerts clinicians when a pre-set threshold is crossed, indicating that a patient is at a higher risk of hospitalization.

According to the findings of the SELENE HF study, published last year in EP Europace, HeartInsight has a 66 percent alert sensitivity and a low false-alert burden, triggering only one every 17 months.

Furthermore, the company claims that the median alert time before an impending HF hospitalization was 42 days, which is earlier than other available solutions.

HeartInsight will be available to patients who have implantable cardiac resynchronization therapy and cardioverter defibrillation devices that are compatible.

The solution is integrated into the company’s Home Monitoring platform, which displays health data from a patient’s cardiac implant that is automatically transmitted each day.

Heart disease market overview

These multi-parameter remote monitoring devices are used not only by medical professionals but also by the health-conscious population, as sleep and activity monitors fall in these categories.

The increased death rate from chronic diseases in both developed and developing countries, such as the United States, raises public awareness of the importance of using early and simple monitoring devices.

According to the American Heart Association’s 2020 Heart Disease and Stroke Statistical Update Fact Sheet, an estimated 126.5 million people worldwide had ischemic heart disease in 2017, with males being more affected than females (68.5 and 57.9 million people, respectively).

 Furthermore, the ability to monitor a wide range of chronic conditions, such as cardiovascular conditions, is expected to drive demand for remote patient monitoring systems.

To increase market revenue, market participants used a variety of strategies such as product launches, product development, collaborations, and expansions.

For example, Masimo Corporation received FDA approval for the Neonatal RD SET Pulse Oximetry Sensors in December 2019.

Recent developments

Philips and BioIntelliSense announced a strategic collaboration in July 2020 to improve remote patient monitoring solutions.

Philips incorporated the latter’s BioSticker device into its portfolio of remote patient monitoring (RPM) devices, which monitor chronic conditions.

BioTelemetry acquired the On.Demand remote patient monitoring (RPM) platform operated by Envolve People Care Inc., a Centene Corporation subsidiary, in July 2020.

This acquisition adds chronic remote patient monitoring solutions to BioTelemetry’s current portfolio of acute care connected health products and services, with a focus on diabetes, hypertension, and chronic heart failure.

In January, Implicity, a provider of remote patient monitoring and cardiac data management solutions, has received FDA approval for a novel medical algorithm that analyzes ECG data from implantable loop recorders (ILRs).

The newly cleared 510(k) ILR ECG Analyzer is an artificial intelligence-based algorithm (AI).

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