Four Recent Developments in Cardiotech

If you’ve read my feature article in this issue, you already know that pulsed field ablation (PFA) is an exciting and competitive new market in the cardiovascular technology sector. Some of the largest medical device makers are competing for share of the PFA market, with a few smaller companies making it their main mission.

(If you haven’t yet read it, my article begins on page 64.)

The cardiovascular market is vast, so I decided to share four developments outside the scope of PFA that are in various stages of development. 

AccurKardia’s ECG-Based AI Screening

Granted U.S. Food and Drug Administration (FDA) breakthrough device designation at the beginning of October, the tool is used to screen for aortic valve stenosis—narrowing of the aortic valve.

The software leverages the ubiquity of electrocardiogram (ECG) to spot potential cases within millions of ECGs already present in healthcare system electronic health records. This can help identify and prioritize which patients should undergo echocardiograms for a definitive diagnosis.

AccurKardia believes the solution will be particularly impactful in underserved regions where cardiology specialists and advanced imaging aren’t readily available. The company also hopes by allowing earlier detection and intervention that the software could save payers millions of dollars in healthcare costs, while optimizing resource use and enhancing sustainability of healthcare services.

“Our mission is to improve patient outcomes and save lives by transforming ECG into a broad biomarker, with initial focus in cardiology,” said AccurKardia co-founder and CEO Juan C. Jimenez. “Our AVS detection technology is the first application of its kind in the detection of structural heart disease, where the condition is chronically underdiagnosed, has a high mortality rate, and can otherwise be treated successfully.”

Pi-Cardia’s ‘ShortCut’

This device, granted FDA clearance in September, is touted as the world’s first dedicated leaflet modification device. It allows valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients that are at risk of coronary obstruction.

TAVR has become the preferred treatment for aortic stenosis, recently surpassing surgery even in patients younger than 65. As bioprosthetic valves degenerate over time, these patients will at some point likely need a valve-in-valve procedure to be performed, and a significant portion of them who are at risk for coronary obstruction will require leaflet splitting with ShortCut.

Future planned indication expansion into native and bicuspid valves may mean that around 30% of future TAVR cases will require leaflet modification with ShortCut to be performed safely and obtain optimal results for patients.

Siemens Healthineers’ Blood Test to Predict Heart Attacks

The Atellica IM High-Sensitivity Troponin I (TnIH) blood test earned a new prognosis claim to help identify patients at risk of death and major cardiac events that could occur up to a year after presenting to the emergency department with signs and symptoms of acute coronary syndrome. It’s the first test of its kind in the U.S. to receive FDA clearance for prognosis.

The test was first cleared by the FDA for in vitro diagnostic use in quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) to help diagnose acute myocardial infarction. The Atellica IM TnIH blood test is used in many hospitals across the country to measure cardiac troponin I in a patient’s blood. Cardiac troponin I is a specific and sensitive biomarker that indicates heart muscle injury.

With a 10-minute time to the first result, the Atellica IM TnIH test now can be used as an aid in prognosis for 30-, 90-, 182-, and 365-day all-cause mortality and major adverse cardiac events in patients presenting with signs and symptoms suggestive of acute coronary syndrome.

Elucid’s PlaqueIQ Image Analysis Software

PlaqueIQ gained FDA clearance in the beginning of October. It’s described as the first FDA-cleared non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, for characterization of plaques.

PlaqueIQ utilizes first-line diagnostic CCTA and develops comprehensive, interactive reports to help physicians virtually “see” plaque at the vessel level. Use of the software can potentially enable earlier identification of higher-risk plaque before the presence of symptoms or major adverse events.

Physicians send patient images to Elucid with a single click, Elucid then applies PlaqueIQ’s image-restoration algorithms to the file to mitigate motion and calcium blooming artifacts. Specially trained analysts segment the data, creating a 3D model of the patient’s coronary arteries. The software then identifies, classifies, and quantifies tissue structure and composition.

Elucid is currently performing beta testing on PlaqueIQ and anticipates making the software available for limited release later in Q4 2024. The company is also pursuing an indication for non-invasive measurement of fractional flow reserve, derived from its PlaqueIQ technology, to measure coronary blockages and the extent of ischemia.